MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-05-19 for WILLOW 855038008128 manufactured by Thai Haso Ltd..
[145479849]
Customer reported that she had a red rash on her skin and itchy palms and feet and sought medical treatment. Customer claims that her rash was an anaphylactic allergic reaction to latex that was caused after wearing willow incontinence underwear for 16 hours.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3014498534-2019-10001 |
| MDR Report Key | 8622579 |
| Date Received | 2019-05-19 |
| Date of Report | 2019-04-05 |
| Date of Event | 2019-02-17 |
| Date Facility Aware | 2019-02-19 |
| Report Date | 2019-04-15 |
| Date Reported to FDA | 2019-04-15 |
| Date Reported to Mfgr | 2019-04-15 |
| Date Added to Maude | 2019-05-19 |
| 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 | 3 |
| 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 | INCONTINENCE UNDERWEAR |
| Product Code | EYQ |
| Date Received | 2019-05-19 |
| Model Number | 855038008128 |
| Device Availability | N |
| Device Age | 1 YR |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | THAI HASO LTD. |
| Manufacturer Address | BANGSAOTHONG, 10570 TH 10570 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-05-19 |