MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-04-05 for SILICONE INJECTION manufactured by Unk.
[21675003]
Pt received silicone injections to buttock area. Developed alveolar hemorrhage which required icu admission to (b)(6) now on day 6.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5029690 |
| MDR Report Key | 3052704 |
| Date Received | 2013-04-05 |
| Date of Report | 2013-04-05 |
| Date of Event | 2013-03-29 |
| Date Added to Maude | 2013-04-12 |
| 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 | 0 |
| Reporter Occupation | PHARMACIST |
| 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 | SILICONE INJECTION |
| Generic Name | SILICONE INJECTION |
| Product Code | KGM |
| Date Received | 2013-04-05 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | UNK |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Deathisabilit | 2013-04-05 |