InjuryMDA
MMC SILICONE GEL SHEETING
Received Feb 23, 1998 · Event occurred Jan 4, 1998
Report 2021296-1998-00001 · MDR key 151935
Device
Generic name
Silicone Gel Sheeting
Manufacturer
Cui CorporationModel number
NACatalog number
MMC-91
Lot number
3-105061
Patient
UNKNOWN
Narrative
Description of Event or Problem
PHYSICIAN INDICATED THAT PT BEGAN TO HAVE SIGNFICIANT BLISTERING SHORTLY AFTER USING GEL SHEETING. HE BELIEVES THAT PROBLEM DEVELOPED INTO FULL THICKNESS SKIN NECROSIS DUE TO SECONDARY INFECTION. PROBLEM DID NOT DEVELOP WHERE SHEETING WAS APPLIED, BUT IN AREAS NEARBY. PHYSICIAN DID NOT FEEL THE DEVICE WAS INVOLVED, HOWEVER HE DID NOT FEEL HE COULD RULE OUT THE POSSIBLITY, SO CUI IS REPORTING IN GOOD FAITH.