FDA Adverse Event Summary report: N

LIFT SHEET INCLUDED IN A CLEAN UP INFECTION CONTROL SYSTEM

MDR report key: 1932895 · Received December 15, 2010

Report

Report Number
1932895
Date Received
December 15, 2010
Date of Event
December 2, 2010
Report Date
December 15, 2010
Manufacturer
MICROTEK MEDICAL, INC.
Product Code
KME
Report Source
User Facility report
Reporter Location
TX, US
Reporter Occupation
RISK MANAGER

Narratives

Description of Event or Problem · 1

RECENTLY WE REVIEWED A SURGERY CASE WHERE A PATIENT ALMOST SLID OFF AN OR TABLE. IT WAS DETERMINED THE PATIENT WAS CORRECTLY POSITIONED. DURING THE REVIEW STAFF MADE A COMMENT REGARDING A CONTRIBUTING FACTOR COULD HAVE BEEN THE LIFT SHEET. THEY REPORTED THE LIFT SHEETS WERE "SLIPPERY." SOME STAFF MEMBERS SAID THEY QUIT USING THE LIFT SHEETS BECAUSE OF THIS REASON. ADDITIONALLY THE LIFT SHEET WAS NOT ALWAYS USED BECAUSE THE SHEET WOULD STRETCH OR "GIVE" WHEN A PATIENT'S WEIGHT WAS PLACED ON IT. THIS TYPE OF PRODUCT WAS USED FOR APPROXIMATELY ONE YEAR. FROM A HUMAN FACTOR STANDPOINT STAFF DID NOT REPORT THIS EARLIER AS THEY SAID THEY LIKED THE OTHER COMPONENTS INCLUDED IN THE MULTI PACK.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 LIFT SHEET INCLUDED IN A CLEAN UP INFECTION CONTROL SYSTEM LIFT SHEET KME MICROTEK MEDICAL, INC. NA C10318

Patients

Seq Age Sex Outcome Treatment
1 *