MAUDE Adverse Event Report: ARJO DOMINICAN REPUBLIC SLING; LIFT, PATIENT, NON-AC-POWERED

Model Number	THA6I-XL-33
Medical Device Problem Code	Tear, Rip or Hole in Device Packaging (2385)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additionla information will be provided upon investigation conclusion.
Event or Problem Description
One of the sling straps had ripped off the sling.The sling damage was discovered in the laundry.
Additional Manufacturer Narrative
The collected information are currently analyzed.Additional information will be provided upon investigation conlusion.
Additional Manufacturer Narrative
The customer reported that one of the sling straps was broken and frayed.It was impossible to determine which strap was defective (shoulder or leg) as the customer sent a picture of the strap, not the whole sling.The sling failure was discovered in the laundry.No injuries were reported.It is unknown under what circumstances the sling malfunctioned; the broken strap was found in the laundry.The manufacturer requested that the sling be returned for further evaluation, but the sample was thrown away.Therefore, it was not possible to evaluate the sling, and define the root cause of reported malfunction.The review of complaints showed that the complaint is a singular occurrence.The instruction for use for hammock sling ( 001.03680) states that: " caution: if any abnormalities are detected after the sling inspection, or if you have any doubts about the sling safety, as a precaution and to ensure safety, stop using it." it was reported by the customer that the sling strap detached, and from that perspective, the sling did not meet the manufacturer¿s specifications.The malfunction occurred before use with the patient.No injuries were reported.The complaint was decided to be reportable due to the allegation of sling strap detachment.
Additional Manufacturer Narrative
The reporter's first and last name, the customer's email, and the customer's phone number were added.The device is distributed outside the us, and no gudid information exists.

• Brand Name: SLING
• Common Device Name: LIFT, PATIENT, NON-AC-POWERED
• Manufacturer (Section D): ARJO DOMINICAN REPUBLIC; building 9 piisa industrial pa km18 1/2 antigua carretera s; itabo 10903 ; DR 10903
• Manufacturer (Section G): ARJO DOMINICAN REPUBLIC; building 9 piisa industrial pa km18 1/2 antigua carretera s; itabo 10903 ; DR 10903
• Manufacturer Contact: justyna kielbowska ; ks. wawrzyniaka 2; komorniki 62-05-2 ; PL 62-052 ; 883337089
• MDR Report Key: 20759276
• Report Number: 3012292104-2024-00007
• Device Sequence Number: 9356233
• Product Code: FSA
• UDI-Device Identifier: 05055982773898
• UDI-Public: (01)05055982773898(11)240304
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 04/22/2026

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
• Operator of Device: Health Professional
• Device Model Number: THA6I-XL-33
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/24/2024
• Supplement Date Received by Manufacturer: Not provided; Not provided; Not provided
• Initial Report FDA Received Date: 11/22/2024
• Supplement Report FDA Received Date: 12/20/2024; 01/30/2025; 04/22/2026
• Date Device Manufactured: 03/04/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown