inforMED
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 Corporation

Model number

NA

Catalog 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.