MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1993-04-09 for DISPOSABLE PERFORATOR 14MM WITH HUDSON END 26-1221 manufactured by Codman.
[3475]
Perforator jammed and did not stop when cranium drilled. Can result in a dural tear. Caused a dural tear and significant blood loss to patient. Device labeled for single use. Patient medical status prior to event: unknown. 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 not evaluated after the event. Method of evaluation: no data. Results of evaluation: no data. Conclusion: no data. Certainty of device as cause of or contributor to event: yes. Corrective actions: device permanently removed from service. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 5480 |
| MDR Report Key | 5480 |
| Date Received | 1993-04-09 |
| Date of Report | 1993-03-11 |
| Date of Event | 1993-03-04 |
| Date Facility Aware | 1993-03-04 |
| Report Date | 1993-03-11 |
| Date Added to Maude | 1993-07-14 |
| 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 | DISPOSABLE PERFORATOR 14MM WITH HUDSON END |
| Generic Name | PERFORATOR |
| Product Code | HGE |
| Date Received | 1993-04-09 |
| Model Number | 26-1221 |
| Catalog Number | 26-1221 |
| Lot Number | MJ8127 |
| ID Number | H2022612211Y |
| Operator | OTHER HEALTH CARE PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Device Sequence No | 1 |
| Device Event Key | 5175 |
| Manufacturer | CODMAN |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1993-04-09 |