MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-01-14 for PROPLAST manufactured by Vitek.
[3637]
Pt had teflon tmj implant placed in left tmj 6/18/85. During past year has experienced pain, intermittent swelling, and deviation to left side. Implant removed 11/17/93. Pathology review found foreign body granuloma and fibrosis. 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. 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, other, unanticipated adverse reaction - long term. Conclusion: none or unknown. Certainty of device as cause of or contributor to event: yes. Corrective actions: other. The device was not destroyed/disposed of.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7380 |
| MDR Report Key | 7380 |
| Date Received | 1994-01-14 |
| Date of Report | 1993-12-28 |
| Date of Event | 1993-11-17 |
| Date Facility Aware | 1993-11-17 |
| Report Date | 1993-12-28 |
| Date Reported to FDA | 1993-12-28 |
| Date Added to Maude | 1994-03-18 |
| 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 | PROPLAST |
| Generic Name | TEFLON PROPLAST LAMINATED FOSSA IMPLANT |
| Product Code | LJD |
| Date Received | 1994-01-14 |
| ID Number | 1.3 MM (SIZE) |
| Operator | OTHER HEALTH CARE PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | Y |
| Device Sequence No | 1 |
| Device Event Key | 7061 |
| Manufacturer | VITEK |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1994-01-14 |