MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-09-17 for CRILE V. MUELLER manufactured by Mckesson Technologies, Inc..
[120415018]
During surgery the tip of the kelly clamp broke off 1 inch. Identified immediately. No fb (foreign body) retained.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7880813 |
| MDR Report Key | 7880813 |
| Date Received | 2018-09-17 |
| Date of Report | 2018-09-11 |
| Date of Event | 2018-08-16 |
| Report Date | 2018-09-11 |
| Date Reported to FDA | 2018-09-11 |
| Date Reported to Mfgr | 2018-09-17 |
| Date Added to Maude | 2018-09-17 |
| 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 | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CRILE V. MUELLER |
| Generic Name | SURGICAL CLAMP |
| Product Code | GDJ |
| Date Received | 2018-09-17 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MCKESSON TECHNOLOGIES, INC. |
| Manufacturer Address | 220 DAVIDSON AVE SOMERSET NJ 08873 US 08873 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-09-17 |