MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2019-04-24 for ALWAYSHEAVYADULTINCONTINENCEDISCREET manufactured by Procter & Gamble Inc.
[143235579]
As the consumer has not returned the product or provided any product information other than the name, there is not enough information for investigation.
Patient Sequence No: 1, Text Type: N, H10
[143235580]
Asthma attack due to always fragrance [asthma]. Allergic reaction due to always fragrance [hypersensitivity]. Fragrance produced severe allergic reaction/fragrance so intense caused need for nebulizer-always discreet [perfume sensitivity]. The fragrance was not listed/have looked so very hard to find the allergy warning about the fragrance but am yet to find it [product label confusion]. Case description: a female consumer, age unspecified, provided a spontaneous report via social media on 25-mar-2019 that she used always heavy adult incontinence discreet for the first time beginning on an unknown date and the fragrance produced a severe allergic reaction, describing it was so intense that it caused her to have an asthma attack and the need for a nebulizer. She stated that the fragrance was not listed on the product. The case outcome was unknown. Treatment details: nebulizer. Relevant history: hist drug/prev exp: always boutique (the women's boutique pants gave me a severe asthma attack and hives which required a nebulizer. ); always (i've relied on always for years). Concomitant product(s): none reported. No further information was provided. 25-mar-2019 consumer follow-up received: the consumer reported that she administered her auto-adrenaline injector and was taken to the accident and emergency department. She stated that it is critical for labeling to contain whether a product contains fragrance. She reported that she put the product in an air tight storage bag so that it cannot affect her and she has looked very hard to find the allergy warning about the fragrance, but she is yet to find it. She stated that this (her symptoms) is only for opening the packet and pulling out a pair of pants, not even putting them on. The case outcome remained unknown. No further information was provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8022168-2019-00001 |
| MDR Report Key | 8545074 |
| Report Source | CONSUMER |
| Date Received | 2019-04-24 |
| Date of Report | 2019-03-25 |
| Date Mfgr Received | 2019-03-25 |
| Date Added to Maude | 2019-04-24 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MGR. REGULATORY FEMININE CARE |
| Manufacturer Street | WINTON HILL BUSINESS CENTER B6280 CENTER HILL AVENUE |
| Manufacturer City | CINCINNATI OH 45224 |
| Manufacturer Country | US |
| Manufacturer Postal | 45224 |
| Manufacturer G1 | PROCTER & GAMBLE INC |
| Manufacturer Street | 355 UNIVERSITY AVE |
| Manufacturer City | BELLEVILLE, ON |
| Manufacturer Country | CA |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ALWAYSHEAVYADULTINCONTINENCEDISCREET |
| Generic Name | GARMENT, PROTECTIVE, FOR INCONTINENCE |
| Product Code | EYQ |
| Date Received | 2019-04-24 |
| Lot Number | NOT AVAILABLE |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PROCTER & GAMBLE INC |
| Manufacturer Address | 355 UNIVERSITY AVE BELLEVILLE, ON CA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-04-24 |