MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1992-09-22 for CODMAN DISPOSABLE PERFORATOR 26-1221 manufactured by Johnson & Johnson/codman Division.
[16030446]
Perforator checked by scrub nurse x 2 and surgeon x 1 as outlined in package insert. As perforator passed through the skull it continued to run and caused laceration of dura. Dura was repaired. Incident resulted in no impairment to the patientdevice labeled for single use. Patient medical status prior to event: fair 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. 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: yes. Corrective actions: none or unknown. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1406 |
| MDR Report Key | 1406 |
| Date Received | 1992-09-22 |
| Date of Event | 1992-03-09 |
| Date Facility Aware | 1992-03-09 |
| Date Reported to Mfgr | 1992-03-20 |
| Date Added to Maude | 1992-09-29 |
| 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 PERFORATION 14MM W/HUDSON END |
| Product Code | KAT |
| Date Received | 1992-09-22 |
| Model Number | 26-1221 |
| Catalog Number | 26-1221 |
| Lot Number | LH845 |
| Operator | OTHER HEALTH CARE PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Device Sequence No | 1 |
| Device Event Key | 1349 |
| Manufacturer | JOHNSON & JOHNSON/CODMAN DIVISION |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1992-09-22 |