MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-02-21 for WILLOW manufactured by Rewoven, Inc.
[137372378]
I used a new urinary incontinence panties product called willow ((b)(6)). After about 12-16 hours of use, i developed a severe rash covering my body from my scalp down to my knees. The rash was intensely red, pruritic, hot to touch, swollen lesions. The palms of my hands and feet were very itchy. I awoke to this rash at 6:00 in the morning. By the time i arrived at the emergency room, i was wheezing and having a difficult time breathing. I was treated with iv steroids, iv fluids and vistaril im. I was discharged with a 5 day burst of prednisone, and discharged home after several hours. Why was the person using the product? Urinary incontinence.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5084279 |
| MDR Report Key | 8366288 |
| Date Received | 2019-02-21 |
| Date of Report | 2019-02-19 |
| Date of Event | 2019-02-17 |
| 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 | WILLOW |
| 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 | REWOVEN, INC |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2019-02-21 |