MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1993-12-13 for CODMAN DISPOSABLE PERFORATOR 26-1221 manufactured by Codman & Shurtleff, Inc..
[2552]
Female patient in or trauma-disposable perforator used to drill burr-hole - malfunctioned - cut dura. Instrument should automatically stop prior to dura. Patient had sutures to dura - no further injury. Device labeled for single use. Patient medical status prior to event: invalid data. 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. Conclusion: invalid data. Certainty of device as cause of or contributor to event: invalid data. Corrective actions: device temporarily removed from service. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6395 |
| MDR Report Key | 6395 |
| Date Received | 1993-08-31 |
| Date of Event | 1993-07-22 |
| Date Facility Aware | 1993-07-22 |
| Date Reported to Mfgr | 1993-08-06 |
| Date Added to Maude | 1993-09-02 |
| 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 | CODMAN DISPOSABLE PERFORATOR |
| Generic Name | DISPOSABLE PERFORATOR 14MM WITH HUDSON END |
| Product Code | HGE |
| Date Received | 1993-12-13 |
| Model Number | 26-1221 |
| Catalog Number | 26-1221 |
| Lot Number | BK8093 |
| Operator | OTHER HEALTH CARE PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Device Sequence No | 1 |
| Device Event Key | 6084 |
| Manufacturer | CODMAN & SHURTLEFF, INC. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1993-08-31 |