MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2012-08-24 for * G-6050 manufactured by Applied Medical Resources Corp..
[2889447]
Mammary takedown required use of disposable "bulldog" clip to occlude blood flow until anastamosis. Surgeon noted blood in chest and discovered that the "bulldog" had fallen apart. All pieces were recovered.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2767085 |
| MDR Report Key | 2767085 |
| Date Received | 2012-08-24 |
| Date of Report | 2012-08-24 |
| Date of Event | 2012-08-02 |
| Report Date | 2012-08-24 |
| Date Reported to FDA | 2012-08-24 |
| Date Added to Maude | 2012-10-01 |
| 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 | * |
| Generic Name | SURGICAL CLIP |
| Product Code | DSS |
| Date Received | 2012-08-24 |
| Model Number | * |
| Catalog Number | G-6050 |
| Lot Number | 1162678 |
| ID Number | * |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | APPLIED MEDICAL RESOURCES CORP. |
| Manufacturer Address | 22872 AVENIDA EMPRESA RANCHO SANTA MARGARITA CA 92688 US 92688 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-08-24 |