MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2004-06-04 for HEMO CLIPS 523800 UNK manufactured by Weck.
[15739504]
Pt had quadruple coronary artery bypass grafts with no intraoperative complications. Immediately postoperatively the pt hemorrhaged and developed cardiac tamponade. Upon reopening, bleeding from a vein graft was observed and repaired. Surgical clips that had been applied during surgery were missing.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 528877 |
| MDR Report Key | 528877 |
| Date Received | 2004-06-04 |
| Date of Report | 2004-06-03 |
| Date of Event | 2004-05-04 |
| Date Facility Aware | 2004-05-18 |
| Report Date | 2004-06-03 |
| Date Reported to FDA | 2004-06-03 |
| Date Reported to Mfgr | 2004-06-03 |
| Date Added to Maude | 2004-06-10 |
| 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 |
| 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 | HEMO CLIPS |
| Generic Name | TITANIUM LIGATING CLIP |
| Product Code | DSS |
| Date Received | 2004-06-04 |
| Model Number | 523800 |
| Catalog Number | UNK |
| Lot Number | UNK |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | * |
| Implant Flag | Y |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 518065 |
| Manufacturer | WECK |
| Manufacturer Address | * RESEARCH TRIANGLE PARK NC * US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening; 2. Required No Informationntervention | 2004-06-04 |