MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-07-06 for MAYO-HEGAR NEEDLE DRIVER manufactured by Sklar Surgical Instruments.
[49164191]
Mayo-hegar needle driver broke during use. Needle was being released and metal piece popped off onto mayo stand. Needle driver removed from sterile field and reported an unsafe. Manufacturer: please note that we do not send products to the mfr, but you may arrange for pick-up by calling my number below.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5063281 |
| MDR Report Key | 5778204 |
| Date Received | 2016-07-06 |
| Date of Report | 2016-06-29 |
| Date of Event | 2016-06-08 |
| Date Added to Maude | 2016-07-08 |
| 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 | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | MAYO-HEGAR NEEDLE DRIVER |
| Generic Name | NEEDLE DRIVER |
| Product Code | KOA |
| Date Received | 2016-07-06 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SKLAR SURGICAL INSTRUMENTS |
| Manufacturer Address | 889 SOUTH MATLACK STREET WEST CHESTER PA 19382 US 19382 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2016-07-06 |