MalfunctionFYB

SRI/SURGICAL EXPRESS, INC

Received Jan 6, 2005 · Event occurred Dec 8, 2004

Report 2028626-2005-00001 · MDR key 565625

Device

Generic name

Surgical Gown, Large, Liquidproof, Ns

Manufacturer

Sri/surgical Express, Inc.

Model number

Catalog number

7503X

Lot number

409790

Product problems

Nonstandard Device

Patient

Unknown (for use when the patient's condition is not known)

Narrative

Description of Event or Problem

AN SDP TECHNICIAN WHO WAS WASHING INSTRUMENTS IN A BASIN OF CLEANING SOLUTION, REPORTED EXPERIENCING A STRIKE THROUGH OF FLUID INSIDE THE SLEEVES OF A LIQUIDPROOF SURGICAL GOWN. IT IS ALLEGED THAT THE CLEANING SOLUTION SOAKED THROUGH.