MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2008-04-09 for SILICONE INJECTIONS manufactured by .
[843906]
"hi, i was injected with silicone injections in 2002 when a friend took me to a place where she was getting some injections, this stupid lady tell me that you don't do the injections to and i say i scare, and she say is nothing to scare everything be fine and now i fell some pain and my hips close to the buttock area where this woman injected me. I don't know why, but and after i was reading for information in the computer, i can't believe that woman lie to me, and i'm so sad how can doctors remove that please help im on pain now recommend some doctors i can believe i passing for this".
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5006333 |
| MDR Report Key | 1032534 |
| Date Received | 2008-04-09 |
| Date of Report | 2008-04-08 |
| Date of Event | 2002-06-15 |
| Date Added to Maude | 2008-04-28 |
| 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 | PATIENT |
| 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 INJECTIONS |
| Generic Name | NONE |
| Product Code | KGM |
| Date Received | 2008-04-09 |
| Device Availability | N |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 1000848 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening | 2008-04-09 |