MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-09-21 for STERISTRIPS manufactured by Unk.
[121853881]
The pt had a skin allergy to the steristrips. The pt experience a rash while on the sulfa.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5080073 |
| MDR Report Key | 7902009 |
| Date Received | 2018-09-21 |
| Date of Report | 2018-09-18 |
| Date Added to Maude | 2018-09-24 |
| 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 |
| 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 | STERISTRIPS |
| Generic Name | STRIP, ADHESIVE, CLOSURE, SKIN |
| Product Code | FPX |
| Date Received | 2018-09-21 |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | UNK |
| Manufacturer Address | UNK UNK |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-09-21 |