MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2013-10-30 for ALWAYS MAXI PAD, OVERNIGHT UNSCENTED manufactured by Procter & Gamble, Inc..
[15199415]
Allergic reaction [hypersensitivity]. Throat swelling, airway closing up [pharyngeal oedema]. Tongue started feeling funny then had tongue swelling [swollen tongue]. Lips swelling [lip swelling]. Hands and feet started to itch [pruritus]. Case description: a man reported that his wife, age unspecified, used always maxi pad, overnight unscented pad, for the first time, 1 applic, 1 only on (b)(6) 2013 and within seconds of application she had an allergic reaction where her hands and feet started to itch, tongue started to feel funny then she had swelling of her lips, tongue and throat and her throat was closing up to the point that she had difficulty talking. Within fifteen mins, her husband took her to a doctor's office close to a hospital where an epi-pen and another unspecified shot was administered to stop the swelling. Her husband mentioned that she started shaking after the epi-pen was administered but within ten minutes after the shot was administered his wife was almost back to normal. His wife was given three prescriptions: epi pen, loratadine and methylprednisolone. She discontinued use of the product and used the pads that she used previously. The case outcome was recovered. Past medical history included: allergy - none. Concomitant medications included: antihypertensives. No further info was provided.
Patient Sequence No: 1, Text Type: D, B5
[15661946]
Lot number (3213478600342130630) provided by the reporter, product requested but not received to date. Product and lot number investigation pending.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8022168-2013-00001 |
| MDR Report Key | 3472049 |
| Report Source | 04 |
| Date Received | 2013-10-30 |
| Date of Report | 2013-10-16 |
| Date of Event | 2013-10-15 |
| Date Mfgr Received | 2013-10-16 |
| Date Added to Maude | 2013-12-23 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Street | 6110 CENTER HILL AVENUE WINTON HILL BUSINESS CTR |
| Manufacturer City | CINCINNATI OH 45224 |
| Manufacturer Country | US |
| Manufacturer Postal | 45224 |
| Manufacturer G1 | PROCTER & GAMBLE, INC. |
| Manufacturer Street | 355 UNIVERSITY AVE. |
| Manufacturer City | BELLEVILLE, ONTARIO K8N5E9 |
| Manufacturer Country | CA |
| Manufacturer Postal Code | K8N 5E9 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ALWAYS MAXI PAD, OVERNIGHT UNSCENTED |
| Generic Name | NONE |
| Product Code | HHD |
| Date Received | 2013-10-30 |
| Lot Number | 3213478600342130630 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PROCTER & GAMBLE, INC. |
| Manufacturer Address | BELLEVILLE, ONTARIO CA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2013-10-30 |