D
Patient 1
BANDING MECHANISM DID NOT DEPLOY APPROPRIATELY. BANDING WAS UNSUCCESSFUL.
MAUDE MDR 5427728
- MDR report key
- 5427728
- Report number
- MW5060087
- Event key
- 0
- Event type
- 3
- Date of event
- 2015-12-29
- Date received
- 2016-02-05
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 100
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Report source
- P
- Manufacturer link flag
- N
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | COOK MEDICAL 4,6,10 SHOOTER SAEED MULTI-BAND LIGATOR | BAND LIGATOR | WILSON-COOK MEDICAL INC. | FER | MBL-6-OV | W3650380 | * | * |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2016-02-05 | 0 | 1. H; 2. R |