MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1995-12-01 for DISPOSABLE PERFORATOR 26-1221 manufactured by Johnson & Johnson Professional, Inc..
[18082]
Perforator did not stop as soon as cranium was penetrated.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1007815 |
| MDR Report Key | 28396 |
| Date Received | 1995-12-01 |
| Date of Report | 1995-11-15 |
| Date of Event | 1995-11-15 |
| Date Added to Maude | 1995-12-05 |
| Event Key | 0 |
| Report Source Code | Voluntary 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 | 3 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DISPOSABLE PERFORATOR |
| Generic Name | DISPOSABLE PERFORATOR |
| Product Code | HFB |
| Date Received | 1995-12-01 |
| Catalog Number | 26-1221 |
| Lot Number | KM806 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 29331 |
| Manufacturer | JOHNSON & JOHNSON PROFESSIONAL, INC. |
| Manufacturer Address | RAYNHAM MA 02767 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1995-12-01 |