FDA Adverse Event
Malfunction
Summary report: N
NIR W/SOX MONORAIL
MDR report key: 334182
·
Received May 17, 2001
Report
- Report Number
- 6000089-2001-00067
- Event Type
- Malfunction
- Date Received
- May 17, 2001
- Date of Event
- March 12, 2001
- Report Date
- March 14, 2001
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION, IRELAND, LTD
- Product Code
- MAF
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TU
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT PRIOR TO A CORONARY STENT PROCEDURE, IT WAS DISCOVERED THAT THE OUTER PACKAGING IS LABELED AS A 16MM 3.0 NIR W/SOX MONORAIL CATHETER, LOT NUMBER 3284104. THE INSIDE POUCH AND PRODUCT ARE LABELED AS A 16MM 3.0 NIR W/SOX CATHETER, LOT NUMBER 3247343. SAME CASE AS MFG. REPORT # 6000089-2001-68, 600089-2001-00076 AND 600089-2001-00077.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 23591 | NIR W/SOX MONORAIL | CORONARY STENT DELIVERY SYSTEM | MAF | BOSTON SCIENTIFIC CORPORATION, IRELAND, LTD | NIR REV 0 ELITE 16MM X 3.0 (7 CELL) | 3284104 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN |