3M FUTURO KNEE COMFORT SUPPORT WITH STABILIZER
Received Feb 7, 2020 · Event occurred Feb 4, 2020
Report MW5092850 · MDR key 9686612
Device
Generic name
Stocking, Medical Support (to Prevent Pooling Of Blood In Legs)
Manufacturer
3m CompanyModel number
34-8721-5433-0/0917Lot number
N/A
Product problems
- Break
Patient
62 YR
- Pain
- Pain
Narrative
Description of Event or Problem
I PURCHASED A 3M FUTURO SUPPORT BRACE ON (B)(6) 2019. I USED IT TO SUPPORT AN ARTHRITIC LEFT KNEE WHEN I EXERCISE AT MY FITNESS CENTER. DURING EXERCISE ON (B)(6) 2020, I NOTICED A SHARP PAIN ON THE LEFT SIDE OF MY KNEE CAP. WHEN I REMOVED THE SUPPORT BRACE, I NOTICED THAT THE STEEL STABILIZER MESH BROKE IN HALF AND PIERCED THROUGH THE FABRIC DIGGING INTO MY KNEE. LATER YESTERDAY, I RETURNED THE SUPPORT BRACE TO (B)(6) AND RECEIVED A NEW ONE. THE SUPPORT BRACE DOES WORK WELL BUT THE MANUFACTURER SHOULD BE MADE AWARE OF THE DEFECT WITH THE STABILIZER AND IT¿S ABILITY TO DO BODILY HARM. FDA SAFETY REPORT ID # (B)(4).