MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2010-10-01 for 3M ESPE RELIX UNICEM APPLICAP/MAXICAP manufactured by 3m.
[1473120]
Pt experienced an immediate allergic reaction after placement. Implantation, pain and left ear pain. Discomfort when blowing nose. No info on product given to pt.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5017633 |
| MDR Report Key | 1852921 |
| Date Received | 2010-10-01 |
| Date of Report | 2010-10-01 |
| Date of Event | 2010-09-01 |
| Date Added to Maude | 2010-10-08 |
| 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 | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 3M ESPE RELIX UNICEM APPLICAP/MAXICAP |
| Generic Name | PERMANENT CEMENT SELF ADHESIVE |
| Product Code | DYH |
| Date Received | 2010-10-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | 3M |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2010-10-01 |