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

Model Number FMC 116

Device Problems Break (1069); Material Separation (1562); Split (2537)

Patient Problems Death (1802); Concussion (2192)

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.

• Brand Name: LUMEX FULL-BODY MESH COMMODE SLING
• Type of Device: FULL BODY MESH COMMODE SLING, GHF-DSLR115
• Manufacturer (Section D): GRAHAM-FIELD; 2935 northeast parkway; atlanta GA 30360 280
• MDR Report Key: 3788064
• MDR Text Key: 4430412
• Report Number: 3788064
• Device Sequence Number: 1
• Product Code: FNG
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• 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 Received: 04/25/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FMC 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 FDA: 04/25/2014
• Distributor Facility Aware Date: 02/24/2014
• Device Age: 6 MO
• Event Location: Nursing Home
• Date Report to Manufacturer: 04/25/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: MODEL: PC350S4, SERIAL: (B)(4).; HOYER LIFT, MAKE: SUNRISE MACHINE AND TOOL (SMT)
• Patient Outcome(s): Death; Hospitalization; Life Threatening
• Patient Age: 93 YR
• Patient Weight: 85