ALWAYSPADSULTRATHINULTRABASEVERWINGLONGNONDO

[83541249] 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 (b)(6) 2017 with a duplicate mfr. Report # 8022168-2017-00001. This corrected initial submission, including product investigation, has the actual mfr report #.
Patient Sequence No: 1, Text Type: N, H10

[83541250] 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. On 07-jul-2017 received product investigation results: (conclusion code) manufactured as intended based on investigation: the production lot code 61837786401830283 entered at intake is not a complete or correct lot code. From the production records the lot code should be 6183478600381830283. The consumer has not returned samples to be evaluated. Retains were reviewed and no visible defects were found. The investigation results indicate that the subject product was manufactured as intended. No definitive root cause for the reported issue could be determined; however no plant cause was identified. No further investigation can be performed at this time. Quality assurance will continue to monitor this complaint code for signals and trends as part of the surveillance program of post market product complaint data.
Patient Sequence No: 1, Text Type: D, B5