MAUDE Adverse Event Report: HANDICARE HANDICARE; DISPOSABLE POSITIONING SLING

Model Number	547810
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/01/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Customer reported an mdr to fda: "while transferring the patient from the bed that patient arrived in from outpatient setting to bariatric hospital bed using a hoyer that is approved for 1000lbs and a transfer sheet also approved for 1000lbs, the transfer sheet ripped when lifting the patient over the bed.The patient was immediately lowered onto his outpatient bed and the maneuverer was aborted.The patient stated he was okay and not injured.The lift was about 4-5 inches above the bed when it ripped.".
Additional Manufacturer Narrative
Incident was not communicated to us directly but via an mdr (b)(4) the user submitted to fda.This is a single-use device that is marked with "disposable" and "do not wash" on the product label.The ifu also states that the sling is disposable and cannot be laundered.In the user reported mdr, the user responded "yes" to the question "is this a single-use device that was reprocessed and reused on a patient".This device is not intended to be washed and reused and doing so can cause degredation of the material which could potentially lead to the issue the user experienced.

• Brand Name: HANDICARE
• Common Device Name: DISPOSABLE POSITIONING SLING
• Manufacturer (Section D): HANDICARE; 10888 metro ct.; maryland heights, mo 63043 ; CA 63043
• Manufacturer (Section G): CORDICA MEDICAL; 1180 mike allen ave.; lot 9 parque industrial; reynosa, reynosa tamaulipas C.P. 8878; MX C.P. 88788
• Manufacturer Contact: lauren stover ; 10888 metro ct.; maryland heights, MO 63043 ; 3149436468
• MDR Report Key: 25247753
• Report Number: 3007802293-2026-00002
• Device Sequence Number: 9596894
• Product Code: FSA
• UDI-Device Identifier: 00810045514659
• UDI-Public: 00810045514659
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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: Other
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 05/21/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 547810
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/21/2026
• Supplement Date Received by Manufacturer: 04/21/2026
• Initial Report FDA Received Date: 05/21/2026
• Supplement Report FDA Received Date: 06/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 36 YR
• Patient Sex: Male