ALWAYSPADSULTRATHINULTRABASEVERWINGLONGNONDO

[76315686] Return of product has been requested. A lot number was provided by the reporter. Full evaluation will occur upon receipt of returned product.
Patient Sequence No: 1, Text Type: N, H10

[76315687] Bladder infection [cystitis], urinary tract infection [urinary tract infection], urinating blood [haematuria], allergic to the pads [hypersensitivity], spotted red rash all over private area-female genital [genital rash], burning sensation all over private area-female genital [genital burning sensation], itching all over private area-female genital [pruritus genital], rash in pad area [medical device site rash], burning sensation in pad area [medical device site paraesthesia], itching in pad area [medical device site pruritus], allergic broke out from pads [medical device site hypersensitivity]. Case description: a (b)(6) old female consumer reported via phone on (b)(6) 2017 that she used always pads ultra thin ultra base version wing long non deodorant 1 pad, 4 times a day ending two and half weeks ago on (b)(6) 2017 and she was allergic to them. She clarified that she initially experienced a red spotted rash in the area of the pad (genital/private area), had a burning sensation, and itching. She asserted that on the third day of experiencing the rash, she started urinating blood, called her physician, who advised her to go to the emergency room. According to the consumer, she was admitted to the hospital for four days with a bladder infection and urinary tract infection. Treatment consisted of antibiotics intravenously while in the hospital. Also, she had to go back to the hospital for intravenous antibiotics as an outpatient afterwards. Product use was discontinued. The case outcome was recovered. Relevant history: allergy: allergic to some laundry soap; drug allergies: allergic to lots of medications. Concomitant product(s): none reported. Other product used previously: yes, had used always infinity pads and broke out in genital rash. Exact product used previously: yes. No further information was provided.
Patient Sequence No: 1, Text Type: D, B5

[84438408] Return of product has been requested. A lot number was provided by the reporter. Full evaluation will occur upon receipt of returned product. This case was initially submitted on 31-may-2017 with the incorrect mfr report #. Please see the corrected initial submission: 8022168-2017-00001.
Patient Sequence No: 1, Text Type: N, H10

[84438409] Bladder infection [cystitis], urinary tract infection [urinary tract infection], urinating blood [haematuria], allergic to the pads [hypersensitivity], spotted red rash all over private area-female genital [genital rash], burning sensation all over private area-female genital [genital burning sensation], itching all over private area-female genital [pruritus genital], rash in pad area [medical device site rash], burning sensation in pad area [medical device site paraesthesia], itching in pad area [medical device site pruritus], allergic broke out from pads [medical device site hypersensitivity]. Case description: a (b)(6) female consumer reported via phone on (b)(6) 2017 that she used always pads ultra thin ultra base version wing long non deodorant 1 pad, 4 times a day ending two and half weeks ago on (b)(6) 2017 and she was allergic to them. She clarified that she initially experienced a red spotted rash in the area of the pad (genital/private area), had a burning sensation, and itching. She asserted that on the third day of experiencing the rash, she started urinating blood, called her physician, who advised her to go to the emergency room. According to the consumer, she was admitted to the hospital for four days with a bladder infection and urinary tract infection. Treatment consisted of antibiotics intravenously while in the hospital. Also, she had to go back to the hospital for intravenous antibiotics as an outpatient afterwards. Product use was discontinued. The case outcome was recovered. Relevant history: allergy: allergic to some laundry soap; drug allergies: allergic to lots of medications. Concomitant product(s): none reported. Other product used previously: yes, had used always infinity pads and broke out in genital rash. Exact product used previously: yes. No further information was provided.
Patient Sequence No: 1, Text Type: D, B5