MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-10-07 for CARE FUSION (V.MUELLER) KRAYENBUEHL NL 3086 manufactured by Care Fusion.
[28347045]
The micro tip of a surgical instrument broke during a surgical procedure. The tip was not recovered. May have gone into suction. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5056957 |
| MDR Report Key | 5148593 |
| Date Received | 2015-10-07 |
| Date of Report | 2015-10-06 |
| Date of Event | 2015-10-05 |
| Date Added to Maude | 2015-10-14 |
| 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 |
| 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 | CARE FUSION (V.MUELLER) KRAYENBUEHL |
| Generic Name | SHORT MICRO BALL TIP HOOK |
| Product Code | GDG |
| Date Received | 2015-10-07 |
| Model Number | NL 3086 |
| Catalog Number | NL 3086 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CARE FUSION |
| Manufacturer Address | 2200, 75 NORTH FAIRWAY DR. VERNON HILLS IL 60061 US 60061 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2015-10-07 |