MAUDE Adverse Event Report: HANDICARE USA, INC. MEDCARE CARE SLING W/HEAD SUPPORT

Model Number	400032
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Codes	Fall (1848); Laceration(s) (1946)
Date of Event	03/03/2021
Type of Reportable Event	Malfunction
Event or Problem Description
While transferring a patient, one of the blue straps broke on the sling (rh shoulder), causing the patient to fall to the floor.Patient received a laceration injury to the left side of patient's forehead when he struck the ground.Patient received x-rays and follow-up treatment for the laceration and will continue to be monitored just in case.The care facility stated there were two cna's in the room at the time of the incident and both were participating in the transfer.Both the sling and the machine it was used on have been removed from service pending an investigation by safety staff at the hospital.
Additional Manufacturer Narrative
This investigation was conducted using submitted photos.The sling does not show signs of long-term fatigue or wear, nor does it show signs of extreme overload.Overload testing was conducted in-house, and the loop did not break in a similar fashion to this complaint.This failure was not able to be replicated, so the root cause is unknown.However, it was most likely caused by external damage during use; for example, the loop getting caught on a nonmoving object or damage from a sharp object such as keys, scissors, or a knife.

• Brand Name: MEDCARE CARE SLING W/HEAD SUPPORT
• Common Device Name: SLING
• Manufacturer (Section D): HANDICARE USA, INC.; 10800 metro court; maryland heights MO 63043
• MDR Report Key: 11547787
• Report Number: 3007802293-2021-00003
• Device Sequence Number: 19706744
• Product Code: FSA
• UDI-Device Identifier: 00810045512006
• UDI-Public: 00810045512006
• Combination Product (Y/N): N
• Initial Reporter State: MS
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date (Section B): 06/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 400032
• Device Catalogue Number: 400032
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/03/2021
• Supplement Date Received by Manufacturer: 03/03/2021
• Initial Report FDA Received Date: 03/22/2021
• Supplement Report FDA Received Date: 06/01/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Weight: 67