MAUDE Adverse Event Report: HANDICARE USA MEDCARE SLINGS; PATIENT SLINGS

Device Problems Break (1069); Material Frayed (1262)

Patient Problems Death (1802); Head Injury (1879)

Event Date 02/23/2018

Event Type  Death  

Manufacturer Narrative

Initial report sent to fda by coroner office with report # mw5078137.Handicare received the notice from fda with medwatch report # mw5078137 on august 30, 2018 regarding the incident.The user facility never informed the manufacturer in regards to the incident.The device involved in this incident was discarded, no further investigation from the manufacturer is planned.See file page 6 of 9 for more details.[(b)(4)].

Event Description

Patient was being lifted from his bed to a chair via a mechanical lift, while patient was suspended in the air, one of the loops on a strap of the lift sling broke and the patient fell, striking his head on the ground.Patient suffered a traumatic head injury and later dies from his injuries.The cna performing the lift did ot use the assistance of a second staff member per nursing home policy, and a different loop broke on the mechanical lift sling about a week prior, but the sling was never replaced.According to other staff members, the loops were frayed and the seams were weak when they used ir for transferring the patient.Nursing home was cited for multiple violations related to the incident.

• Brand Name: MEDCARE SLINGS
• Type of Device: PATIENT SLINGS
• Manufacturer (Section D): HANDICARE USA; 10888 metro court; maryland heights 63043
• Manufacturer (Section G): HANDICARE USA; 10888 metro court; maryland heights 63043
• Manufacturer Contact: rekha janarthanan ; 10888 metro court; maryland heights 63043 ; 3142198682
• MDR Report Key: 7855946
• MDR Text Key: 119567313
• Report Number: 3007802293-2018-00039
• Device Sequence Number: 1
• Product Code: FSA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/07/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/30/2018
• Was Device Evaluated by Manufacturer?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Death