FDA Adverse Event Other Summary report: N

8030916-2008-00028

MDR report key: 1150096 · Received August 29, 2008

Report

Report Number
8030916-2008-00028
Event Type
Other
Date Received
August 29, 2008
Product Code
FSA
Report Source
Manufacturer report

Narratives

Additional Manufacturer Narrative · 1

LOCAL DISTRIBUTOR RECEIVED NOTIFICATION OF POSSIBLE INCIDENT AT THIS FACILITY. PHONE CALL TO FACILITY ON 8/6/08 REP SPOKE WITH ADMIN WHO DID NOT KNOW DATE OF THIS ALLEGED INCIDENT, COULD NOT PROVIDE LIFT MODEL TYPE OR SERIAL NUMBER. REPORT RECEIVED INDICATED THAT A NON-LIKO MANUFACTURING SLING WAS USED TO TRANSFER THE RESIDENT. LIKO STRONGLY DISCOURAGES THE USE OF NON-APPROVED SLINGS AND ACCESSORIES WITH THEIR EQUIPMENT. THE SLING USED IN THE TRANSFER WAS NOT A LIKO MANUFACTURING SLING, AND THEREFORE WAS NOT DESIGNED, TESTED OR APPROVED FOR USE WITH A LIKO PT LIFT. USER GUIDES ARE CLEAR IN INSTRUCTION AS TO THE PROPER AND SAFE USE OF THE PRODUCT. THIS INCIDENT IS VIEWED AS USER ERROR AND NOT A PRODUCT PROBLEM. LIFT IS STILL IN USE AT THE FACILITY.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 FSA

Patients

Seq Age Sex Outcome Treatment
1