MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-02-25 for BIOPATCH ANTIMICROBIAL DR manufactured by Johnson And Johnson/ethicon.
[181212042]
Patients reports redness and itching when using biopatch. No other information provided. Reported to (b)(6) by: patient/ caregiver.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5093266 |
| MDR Report Key | 9753317 |
| Date Received | 2020-02-25 |
| Date of Report | 2020-02-07 |
| Date Added to Maude | 2020-02-26 |
| 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 | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BIOPATCH ANTIMICROBIAL DR |
| Generic Name | DRESSING, WOUND, DRUG |
| Product Code | FRO |
| Date Received | 2020-02-25 |
| Device Availability | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | JOHNSON AND JOHNSON/ETHICON |
| Brand Name | NULL NULL |
| Product Code | --- |
| Date Received | 2020-02-25 |
| Device Sequence No | 101 |
| Device Event Key | 0 |
| Manufacturer | J AND J MEDICAL |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-25 |