MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2002-03-01 for BRAVA BRA manufactured by Brava, Llc.
[263769]
Brava bras sells a class 11 medical device to enlarge breasts. A local dr and rptr both tried it and both developed blisters on breasts. When rptr called to complain the person who answered the phone said they did too. How can we force the mfr to warn or improve this product?
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1024232 |
| MDR Report Key | 380305 |
| Date Received | 2002-03-01 |
| Date of Report | 2002-03-01 |
| Date of Event | 2001-12-01 |
| Date Added to Maude | 2002-03-11 |
| 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 | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BRAVA BRA |
| Generic Name | BREAST ENLARGEMENT |
| Product Code | KCZ |
| Date Received | 2002-03-01 |
| Model Number | NA |
| Catalog Number | NA |
| Lot Number | UNK |
| ID Number | * |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Implant Flag | Y |
| Date Removed | V |
| Device Sequence No | 1 |
| Device Event Key | 369352 |
| Manufacturer | BRAVA, LLC |
| Manufacturer Address | 2601 SOUTH BAYSHORE DR #725 COCONUT GROVE FL 331339816 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2002-03-01 |