MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-03-01 for HAENE CLAMP GL 3100 manufactured by V. Muller Instruments -care Fusion-.
[3175007]
Tip of haene clamp broke off in the pt's vaginal during surgical intervention. The tip was retrieved. Diagnosis or reason for use: total vaginal hysterectomy.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5029251 |
| MDR Report Key | 2994393 |
| Date Received | 2013-03-01 |
| Date of Report | 2013-03-01 |
| Date of Event | 2013-03-01 |
| Date Added to Maude | 2013-03-11 |
| 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 | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HAENE CLAMP |
| Generic Name | HAENE CLAMP |
| Product Code | HCZ |
| Date Received | 2013-03-01 |
| Model Number | GL 3100 |
| Catalog Number | GL 3100 |
| Lot Number | GL 3100 |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | V. MULLER INSTRUMENTS -CARE FUSION- |
| Manufacturer Address | * SAN DIEGO CA * US * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2013-03-01 |