MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2004-09-07 for UNK manufactured by Unk.
[19243209]
One year status post rhinoplasty with placement of solid silicone implant. One month history of pain, tenderness, swelling and redness of nasal tip. Failed course of oral antibiotics. In for urgent removal of infected implant.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 542914 |
| MDR Report Key | 542914 |
| Date Received | 2004-09-07 |
| Date of Report | 2004-09-07 |
| Date of Event | 2004-09-03 |
| Date Facility Aware | 2004-09-03 |
| Report Date | 2004-09-07 |
| Date Reported to FDA | 2004-09-07 |
| Date Added to Maude | 2004-09-13 |
| Event Key | 0 |
| Report Source Code | User Facility 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 | UNK |
| Generic Name | SOLID SILICONE NASAL IMPLANT |
| Product Code | EPP |
| Date Received | 2004-09-07 |
| Model Number | UNK |
| Catalog Number | UNK |
| Lot Number | UNK |
| ID Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 1 YR |
| Implant Flag | Y |
| Date Removed | V |
| Device Sequence No | 1 |
| Device Event Key | 532284 |
| Manufacturer | UNK |
| Manufacturer Address | UNK UNK * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2004-09-07 |