FDA Adverse Event
Malfunction
Summary report: N
MULTI-LINK MINI VISION RX CORONARY STENT SYSTEM
MDR report key: 1052383
·
Received May 23, 2008
Report
- Report Number
- 2024168-2008-00424
- Event Type
- Malfunction
- Date Received
- May 23, 2008
- Report Date
- April 23, 2008
- Manufacturer
- ABBOTT VASCULAR-CARDIAC THERAPIES
- Product Code
- MAF
- PMA / PMN Number
- PO20047
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IT
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
.
Description of Event or Problem · 1
REPORTING STATUS: MALFUNCTIONS. REPORTING RATIONALE: LARGER THAN EXPECTED DEVICE COULD CAUSE PT INJURY. DEVICE ISSUE: MISLABELED. THIS EVENT IS BEING FILED CONSERVATIVELY. IT WAS REPORTED THAT WHEN THE PHYSICIAN OPENED A BOX LABELED AS MINIVISION 2.5 X 15, MODEL 1007829-15, LOT NUMBER 7010931, FOUND INSIDE THE POUCH AND THE BOX WAS A VISION 3 X 15, MODEL1007842-15, LOT NUMBER 7120632. THE BOX WAS CLOSED BEFORE OPENING THE PACKAGING. NO ADD'L EVENT OR PT INFO IS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MULTI-LINK MINI VISION RX CORONARY STENT SYSTEM | 74MAF | MAF | ABBOTT VASCULAR-CARDIAC THERAPIES | NA | 7010931 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |