MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1993-04-27 for BREAST PROSTHESIS NI manufactured by Mcghan Texture Breast Prosth..
[3134]
Prosthesis was removed because of capsule formationdevice labeled for single use. Patient medical status prior to event: invalid data. 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. Device used as labeled/intended. Invalid data - regarding evaluation by user after event. Method of evaluation: none or unknown. Results of evaluation: none or unknown. Conclusion: none or unknown. Certainty of device as cause of or contributor to event: invalid data. Corrective actions: device discarded. The device was destroyed/disposed of.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 4749 |
| MDR Report Key | 4749 |
| Date Received | 1993-04-27 |
| Date of Report | 1993-04-02 |
| Report Date | 1993-04-02 |
| Date Reported to Mfgr | 1992-01-08 |
| Date Added to Maude | 1993-06-07 |
| 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 |
| Brand Name | BREAST PROSTHESIS |
| Generic Name | NA |
| Product Code | KCZ |
| Date Received | 1993-04-27 |
| Model Number | NI |
| Catalog Number | NI |
| Lot Number | NI |
| ID Number | SIZE 210CC |
| Operator | OTHER |
| Device Availability | N |
| Device Age | 01-MAR-89 |
| Implant Flag | * |
| Device Sequence No | 1 |
| Device Event Key | 4465 |
| Manufacturer | MCGHAN TEXTURE BREAST PROSTH. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1993-04-27 |