MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1992-07-31 for AUTOMATIC SKULL PERFORATOR - DISP 26-1221 manufactured by Codman Inc..
[1955]
Routine exposure of occipital region for tumor. Burn holes to be placed near sinus - perforator slowed but didn't stop then plunged - sinus bleeding controlled with topical coagulant. 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. Results of evaluation: component failure, fail-safe systems. Conclusion: device failure occurred and was related to event. Certainty of device as cause of or contributor to event: invalid data. Corrective actions: device returned to manufacturer/dealer/distributor. The device was not destroyed/disposed of.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3932 |
| MDR Report Key | 3932 |
| Date Received | 1992-07-31 |
| Date of Report | 1991-12-04 |
| Date of Event | 1991-12-03 |
| Date Facility Aware | 1991-12-03 |
| Report Date | 1991-12-04 |
| Date Reported to FDA | 1991-12-04 |
| Date Reported to Mfgr | 1991-12-04 |
| Date Added to Maude | 1993-05-10 |
| 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 | AUTOMATIC SKULL PERFORATOR - DISP |
| Generic Name | PERFORATOR |
| Product Code | KAT |
| Date Received | 1992-07-31 |
| Catalog Number | 26-1221 |
| Device Availability | Y |
| Implant Flag | N |
| Device Sequence No | 1 |
| Device Event Key | 3671 |
| Manufacturer | CODMAN INC. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1992-07-31 |