MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-11-15 for STYLE 76 DOUBLE LUMEN IMPLANTS NI manufactured by Mcghan.
[5992]
49 yo female who complains of chronic fatigue syndrome after being implanted in may 1985. She was taken to the or and the operative report revealed that there were bilateral capsular and a right ruptured implants. Device labeled for single use. Patient medical status prior to event: fair 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. Device used as labeled/intended. Device was evaluated after the event. Method of evaluation: invalid data, invalid data. Results of evaluation: invalid data. 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 | 9667 |
| MDR Report Key | 9667 |
| Date Received | 1994-11-15 |
| Date of Event | 1994-07-12 |
| Date Facility Aware | 1994-07-12 |
| Date Reported to Mfgr | 1994-07-12 |
| Date Added to Maude | 1995-01-13 |
| 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 |
| Brand Name | STYLE 76 DOUBLE LUMEN IMPLANTS |
| Generic Name | NA |
| Product Code | FGH |
| Date Received | 1994-11-15 |
| Model Number | NI |
| Catalog Number | NI |
| Lot Number | NI |
| ID Number | NI |
| Operator | OTHER HEALTH CARE PROFESSIONAL |
| Device Availability | N |
| Implant Flag | Y |
| Device Sequence No | 1 |
| Device Event Key | 9319 |
| Manufacturer | MCGHAN |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1994-11-15 |