MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-02-05 for COOK MEDICAL 4,6,10 SHOOTER SAEED MULTI-BAND LIGATOR MBL-6-OV manufactured by Wilson-cook Medical Inc..
[37976435]
Banding mechanism did not deploy appropriately. Banding was unsuccessful.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5060087 |
| MDR Report Key | 5427728 |
| Date Received | 2016-02-05 |
| Date of Report | 2016-02-05 |
| Date of Event | 2015-12-29 |
| Date Added to Maude | 2016-02-10 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 | COOK MEDICAL 4,6,10 SHOOTER SAEED MULTI-BAND LIGATOR |
| Generic Name | BAND LIGATOR |
| Product Code | FER |
| Date Received | 2016-02-05 |
| Model Number | MBL-6-OV |
| Lot Number | W3650380 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | WILSON-COOK MEDICAL INC. |
| Manufacturer Address | WINSTON SALEM NC 27105 US 27105 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2016-02-05 |