MalfunctionIOZ
PAVLIK HARNESS
Received Nov 27, 2002
Report 1035617-2002-00004 · MDR key 430667
Device
Generic name
Hip Abduction Device
Manufacturer
Zimmer Orthopaedic Surgical ProductsModel number
*Catalog number
1716
Lot number
NA
Product problems
- Difficult to Remove
Patient
49 DAY
- Laceration(s)
- Therapy/non-surgical treatment, additional
- Treatment with medication(s)
Narrative
Description of Event or Problem
A PT WEARING THE PAVLIK HARNESS CAME FOR A ROUTINE CHECK. WHEN REMOVING THE HARNESS, IT WAS NOTED THAT A STRING FROM THE FRONT VELCRO STRAP HAD CAUGHT ON THEIR CALF AND HAD ALLEGEDLY CAUSED A LACERATION. THE WOUND REQUIRED STERISTRIPS AND A COURSE OF ANTIBIOTICS.