MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-02-21 for ATTENDS PULL UPS manufactured by Attends Healthcare Products / Domtar Ai, Inc.
[137370826]
On (b)(6) 2019 the consumer stated that she opened two packages of the products. The inside of the packages smelled like burnt plastic or pesticides. The consumer also stated that the smell caused her to have headaches. The consumer has purchased the same product for years but never had this problem. On (b)(6) 2019 the consumer contacted the manufacturer and was advised that the smell is not their fault. Product description: adult underwear, product category: personal care, product type: personal protection.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5084290 |
| MDR Report Key | 8366424 |
| Date Received | 2019-02-21 |
| Date of Report | 2019-02-06 |
| Date of Event | 2019-02-03 |
| Date Added to Maude | 2019-02-25 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | ATTENDS PULL UPS |
| Generic Name | GARMENT, PROTECTIVE, FOR INCONTINENCE |
| Product Code | EYQ |
| Date Received | 2019-02-21 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ATTENDS HEALTHCARE PRODUCTS / DOMTAR AI, INC |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-02-21 |