InjuryNOC
PEDI-WRAP
Received Sep 3, 2015 · Event occurred Sep 1, 2015
Report MW5056029 · MDR key 5064100
Device
Product problems
- Protective Measures Problem
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
MEDI-KID CO., SELLS A PRODUCT CALLED PEDI-WRAPS WHICH ARE ARM IMMOBILIZERS FOR KIDS AFTER SURGERY TO KEEP THE KIDS' ARMS STRAIGHT SO THAT THEY CAN'T DAMAGE A NEWLY REPAIRED LIP OR PALATE. I UNDERSTAND THIS IS A CLASS 1 DEVICE AND IS EXEMPT FROM BEING APPROVED. HOWEVER, THEY SELL A SHOULDER STRAP THAT ATTACHES TO THE TOP OF EACH IMMOBILIZER AND WRAP BEHIND THE CHILD'S NECK. THEY INCLUDE THESE TO HELP KEEP THE IMMOBILIZERS FROM SLIPPING OFF THE CHILD'S ARM. THIS STRAP IS APPROX 14" LONG. THIS STRAP IS NOT EXEMPT PER YOUR GUIDELINES AND IS A SERIOUS STRANGULATION HAZARD. I FEEL LIKE THIS IS DEATH WAITING TO HAPPEN.