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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GRAHAM-FIELD LUMEX FULL-BODY MESH COMMODE SLING FULL BODY MESH COMMODE SLING, GHF-DSLR115

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GRAHAM-FIELD LUMEX FULL-BODY MESH COMMODE SLING FULL BODY MESH COMMODE SLING, GHF-DSLR115 Back to Search Results
Model Number FMC 116
Device Problems Break; Material Separation; Split
Event Date 02/24/2014
Event Type  Death  
Event Description

On (b)(6) 2014, at approximately 7:45 pm, nursing home staff attempted to assist resident with a hoyer lift transfer from a shower chair to the resident's bed. During the course of the transfer, the left lower strap of the sling broke suddenly, causing the resident to fall to his left side and to hit his head on the floor. As a result, the resident sustained multiple head and face injuries. He was transferred by ambulance to a local acute care hospital, where he expired a few hours later.

 
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Brand NameLUMEX FULL-BODY MESH COMMODE SLING
Type of DeviceFULL BODY MESH COMMODE SLING, GHF-DSLR115
Manufacturer (Section D)
GRAHAM-FIELD
2935 northeast parkway
atlanta GA 30360 280
MDR Report Key3788064
Report Number3788064
Device Sequence Number1
Product CodeFNG
Report Source User Facility
Reporter Occupation
Type of Report Initial
Report Date 04/25/2014
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/25/2014
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberFMC 116
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA04/25/2014
Distributor Facility Aware Date02/24/2014
Device Age6 mo
Event Location Nursing Home
Date Report TO Manufacturer04/25/2014
Is this a Reprocessed and Reused Single-Use Device? No

Patient TREATMENT DATA
Date Received: 04/25/2014 Patient Sequence Number: 1
Treatment
MODEL: PC350S4, SERIAL: (B)(4).
HOYER LIFT, MAKE: SUNRISE MACHINE AND TOOL (SMT)
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