MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1992-07-31 for 200-221 DG II manufactured by Acra Cut.
[16612463]
The acra cut perforator which was powered by a codman pneumatic cranitome (prod #26-5030) purchased in nov 1991 failed to disongage and plunged into the sinus. 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. Invalid data - regarding whether event presents imminent hazard. Device used as labeled/intended. Invalid data - regarding evaluation by user after event. Method of evaluation: invalid data. Results of evaluation: invalid data. Conclusion: invalid data. Certainty of device as cause of or contributor to event: invalid data. Corrective actions: device returned to manufacturer/dealer/distributor, user education provided. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3925 |
| MDR Report Key | 3925 |
| Date Received | 1992-07-31 |
| Date of Report | 1992-03-05 |
| Date of Event | 1992-01-14 |
| Date Facility Aware | 1992-01-14 |
| Report Date | 1992-03-05 |
| Date Reported to Mfgr | 1992-01-29 |
| 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 |
| Generic Name | DISPOSABLE SKULL PERFORATOR |
| Product Code | KAT |
| Date Received | 1992-07-31 |
| Model Number | 200-221 DG II |
| Catalog Number | 200-221 DG II |
| Lot Number | 907 |
| Operator | OTHER HEALTH CARE PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Device Sequence No | 1 |
| Device Event Key | 3664 |
| Manufacturer | ACRA CUT |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1992-07-31 |