FDA Adverse Event
Malfunction
Summary report: N
ABBOTT VASCULAR
MDR report key: 6452837
·
Received March 31, 2017
Report
- Report Number
- MW5068834
- Event Type
- Malfunction
- Date Received
- March 31, 2017
- Report Date
- March 30, 2017
- Manufacturer
- ABBOTT VASCULAR
- Product Code
- MAF
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Description of Event or Problem · 1
DEFECTIVE PRODUCT (STENT OFF BALLOON WHEN REMOVED FROM PACKAGE), NOT USED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 232642 | ABBOTT VASCULAR | MULTI-LINK MINI VISION RX | MAF | ABBOTT VASCULAR | 2.0X23RX | 5031941 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 71 YR |