MalfunctionIOZ
PAVILIK HARNESS
Received Mar 6, 2002
Report 1035617-2002-00002 · MDR key 381121
Device
Generic name
Hip Abduction Splint
Manufacturer
Zimmer Ortho Surgical ProductsModel number
*Catalog number
00-1716-011-00
Lot number
60110011
Product problems
- Sticking
Patient
NO INFO
- Discomfort
Narrative
Description of Event or Problem
THE HARNESS WAS FITTED TO AN INFANT, THE CHILD SEEMED TO BE IN SOME DISCOMFORT AND WOULD NOT STOP CRYING. ON EXAMINATION OF THE HARNESS THE POINT OF AN INDUSTRIAL SEWING NEEDLES WAS ALLEGEDLY DISCOVERED EMBEDDED IN THE LINING.