DeathMDR
COMFORT WEAR
Received Mar 26, 2003 · Event occurred Feb 7, 2003
Report 1062379-2003-00001 · MDR key 452311
Device
Generic name
Female Girdle
Manufacturer
The Marena Group, Inc.Model number
LGSCatalog number
LGS
Lot number
NA
Product problems
- Unknown (for use when the device problem is not known)
Patient
41 YR
- Death
Narrative
Description of Event or Problem
COMPANY RECEIVED A SUMMONS CLAIMING THAT THEIR GARMENT CAUSED THE DEATH OF PATIENT WHO HAD UNDERGONE LIPOSUCTION. THE GARMENT WAS SOLD BY DISTRIBUTER TO MEDICAL CENTER AND PRESCRIBED BY DR. COMPANY HAS NO FURTHER INFORMATION. FACILITY STOCKED SEVERAL BRANDS OF COMPRESSION GARMENTS AND COMPANY IS NOT 100% CERTAIN COMPANY MANUFACTURED THIS PRODUCT.