MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1998-07-30 for JODEE BRA UNK manufactured by Jodee Bra, Inc..
[110012]
Rptr wore product once, "something oozed out". Rptr sent it back to mfr who would not evaluate the product or give her a replacement.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1014272 |
| MDR Report Key | 179950 |
| Date Received | 1998-07-30 |
| Date of Report | 1998-07-30 |
| Date of Event | 1998-07-01 |
| Date Added to Maude | 1998-08-03 |
| 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 | JODEE BRA |
| Generic Name | EXTERNAL BREAST PROSTHESIS |
| Product Code | KCZ |
| Date Received | 1998-07-30 |
| Model Number | UNK |
| Catalog Number | UNK |
| Lot Number | UNK |
| ID Number | STYLE 44 |
| Operator | LAY USER/PATIENT |
| Device Availability | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 174986 |
| Manufacturer | JODEE BRA, INC. |
| Manufacturer Address | 3100 N. 29TH AVE. HOLLYWOOD FL 33020 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1998-07-30 |