MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-04-23 for KERRISON PUNCH (GOLD TIP) manufactured by Aesculap, Inc.
[3269616]
Small gold tip on 1 mm kerrison punch broke while in use during procedure (surgical). Surgeon retrieved piece.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5029929 |
| MDR Report Key | 3080375 |
| Date Received | 2013-04-23 |
| Date of Report | 2013-04-17 |
| Date of Event | 2013-04-12 |
| Date Added to Maude | 2013-04-29 |
| 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 | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | KERRISON PUNCH (GOLD TIP) |
| Generic Name | NONE |
| Product Code | KBB |
| Date Received | 2013-04-23 |
| ID Number | FF771R |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AESCULAP, INC |
| Manufacturer Address | 3773 CORPORATE PKWY CENTER VALLEY PA 18034 US 18034 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2013-04-23 |