MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2012-10-25 for HEMOSTAT * manufactured by Kny Scheerer.
[19727566]
During the removal of a power port, the hemostat that was clamping the patient's port broke. The nurse specialist successfully located and removed the broken piece of the hemostat from the patient's body. The patient was not injured. Up until four years ago, the hemostats were etched with the date of purchase and this particular hemostat has an etched date, but etching is not legible. The hemostat was inspected visually before packaging into the procedure kit, but the fractured jaw would not be visible with this type of inspection.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2817658 |
| MDR Report Key | 2817658 |
| Date Received | 2012-10-25 |
| Date of Report | 2012-10-25 |
| Date of Event | 2012-09-26 |
| Report Date | 2012-10-25 |
| Date Reported to FDA | 2012-10-25 |
| Date Added to Maude | 2012-11-02 |
| 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 | 0 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HEMOSTAT |
| Generic Name | HEMOSTAT, SURGICAL |
| Product Code | HRQ |
| Date Received | 2012-10-25 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | NURSE |
| Device Availability | Y |
| Device Age | 5 YR |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | KNY SCHEERER |
| Manufacturer Address | * * * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-10-25 |