InjuryIPM
ORTHO SKIN
Received Aug 26, 2015 · Event occurred Aug 20, 2015
Report MW5055846 · MDR key 5045373
Device
Generic name
Waterproof Cast Liner
Manufacturer
Ortho Care Casting, LlcModel number
2"OS2Catalog number
052
Product problems
- Patient-Device Incompatibility
Patient
Not reported
- Local Reaction
Narrative
Description of Event or Problem
SURGEON REPORTED ADVERSE SKIN REACTIONS IN 5/5 PATIENTS POST OPERATIVELY INCLUDING SKIN MACERATION IN 1/5. ALL PATIENT'S HAD APPLIED INTRAOP, "ORTHO SKIN" WATERPROOF CAST LINER. DIAGNOSIS OR REASON FOR USE: APPLIED INTRAOP B SURGEON DURING THE TIMEFRAME. EVENT ABATED AFTER USE STOPPED OR DOSE REDUCED? YES.