MalfunctionITW
MUELLER SPORT CARE ANKLE SUPPORT
Received May 15, 2009 · Event occurred Apr 8, 2009
Report MW5011111 · MDR key 1386562
Device
Product problems
- Tears, rips, holes in device, device material
Patient
58 YR
- Pain
- Physical Entrapment
- Discomfort
Narrative
Description of Event or Problem
THE DEVICE (ANKLE SUPPORT) WAS TIGHT AND CAUSED HIGH DEGREE OF DISCOMFORT WHILE WEARING IT. I BOUGHT SIZE LARGE WHICH THE PACKAGING STATED WAS FOR MEN'S SHOE SIZE 11-13. I WEAR SIZE 10 1/2 SHOE. THE PRODUCT WAS TIGHT AND CONSTRICTIVE ON THE ANKLE. THE PRODUCT INFORMATION ON THE BOX STATED THAT LARGE WAS FOR MEN SHOE SIZE 11-13. I WEAR SIZE 10 1/2. ALSO WHILE PUTTING ON THE PRODUCT THERE WAS A RIPPING SOUND AND UPON EXAMINATION THE PRODUCT WAS RIPPED. DATES OF USE: 2009. DIAGNOSIS OR REASON FOR USE: ANKLE PAIN. EVENT ABATED AFTER USE STOPPED OR DOSE REDUCED: YES.