MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1993-01-26 for BREAST IMPLANTS manufactured by Dow Corning Mammary Implants.
[1011]
Patient with diagnosis of bilateral breast capsules. On 11/25/92 had removal of bilateral breast implants, bilateral capsulectomy. Implants were intact upon removal. Device labeled for single use. Patient medical status prior to event: satisfactory condition. There was not multiple patient involvement. Invalid data - on device service/maintenance. No data - regarding date last serviced. Service provided by: invalid data. Invalid data - service records availability. No imminent hazard to public health claimed. Invalid data - whether device used as labeled/intended. Device was evaluated after the event. Method of evaluation: actual device involved in incident was evaluated, visual examination. Results of evaluation: none or unknown. Conclusion: device failure directly caused event. Certainty of device as cause of or contributor to event: invalid data. Corrective actions: use of all similar devices stopped temporarily. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3248 |
| MDR Report Key | 3248 |
| Date Received | 1993-01-26 |
| Date of Report | 1992-12-03 |
| Date of Event | 1992-11-25 |
| Date Facility Aware | 1992-11-25 |
| Report Date | 1992-12-03 |
| Date Reported to FDA | 1992-12-03 |
| Date Reported to Mfgr | 1992-12-03 |
| Date Added to Maude | 1993-04-13 |
| 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 | 0 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Generic Name | BREAST IMPLANTS |
| Product Code | KCZ |
| Date Received | 1993-01-26 |
| Device Availability | Y |
| Implant Flag | Y |
| Device Sequence No | 1 |
| Device Event Key | 3030 |
| Manufacturer | DOW CORNING MAMMARY IMPLANTS |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1993-01-26 |