MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1993-07-01 for BIO MECHANICAL ANKLE PLAT FORM SYSTEM N/A manufactured by Camp.
[17169665]
Patient using baps board for second rusit. Patient heard a "snap" and was in mucle pain. Invalid data - regarding single use labeling of device. 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. Service records not available. No imminent hazard to public health claimed. Device used as labeled/intended. Device was evaluated after the event. Method of evaluation: visual examination. Results of evaluation: telemetry failure, patient's condition - predisposed event. Conclusion: no failure detected and product within specification. Certainty of device as cause of or contributor to event: invalid data. Corrective actions: none or unknown. The device was not destroyed/disposed of.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 5851 |
| MDR Report Key | 5851 |
| Date Received | 1993-07-01 |
| Date of Report | 1993-03-17 |
| Date of Event | 1993-03-11 |
| Date Facility Aware | 1993-03-11 |
| Report Date | 1993-03-17 |
| Date Reported to FDA | 1993-03-17 |
| Date Added to Maude | 1993-07-27 |
| 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 | BIO MECHANICAL ANKLE PLAT FORM SYSTEM |
| Generic Name | BAP'S BOARD |
| Product Code | INF |
| Date Received | 1993-07-01 |
| Model Number | N/A |
| Catalog Number | N/A |
| Operator | OTHER CAREGIVERS |
| Device Availability | Y |
| Implant Flag | * |
| Device Sequence No | 1 |
| Device Event Key | 5550 |
| Manufacturer | CAMP |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1993-07-01 |