MAUDE Adverse Event Report: HANDICARE USA INC. INDEPENDENT LIFTER

Model Number 753986

Device Problem Device Slipped (1584)

Patient Problems Fall (1848); Bone Fracture(s) (1870)

Event Date 04/21/2017

Event Type  Injury  

Manufacturer Narrative

Outcome of investigation pending.A final report will be submitted upon completion.This report was originally submitted in december 2017.Vijai d jaladhi notified us that the initial report was missing for this submission on september 11, 2020, and asked us to resubmit the report with "initial" checked off (g7).

Event Description

Individual using the independent lifter had the leg supports slip from under both legs as they were being lifted up.In an attempt to lower themselves down they fell to the floor.They reported having fractures to the following areas: left hip, left tibia, left foot, left pinky toe, and right fibula.The patient has osteoporosis, and went to the hospital for treatment.

• Brand Name: INDEPENDENT LIFTER
• Type of Device: INDEPENDENT LIFTER
• Manufacturer (Section D): HANDICARE USA INC.; 10888 metro ct.; maryland heights MO 63043
• Manufacturer (Section G): HANDICARE USA INC.; 10888 metro ct.; maryland heights MO 63043
• Manufacturer Contact: laren mcintosh ; 10888 metro ct.; maryland heights, MO 63043 ; 3142198614
• MDR Report Key: 7143088
• MDR Text Key: 214542982
• Report Number: 3007802293-2017-00111
• Device Sequence Number: 1
• Product Code: FSA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: 753986
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/08/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Sex: Male