MAUDE Adverse Event Report: Arjo Dominican Republic Disposable clip sling; Lift, Patient, Non-Ac-Powered

Model Number	MFA1000M-XL-L1
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/17/2026
Type of Reportable Event	Malfunction

• Brand Name: Disposable clip 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 ; +48()883337089
• MDR Report Key: 50231533
• Report Number: 3012292104-2026-00013
• Device Sequence Number: 10344748
• Product Code: FSA
• UDI-Device Identifier: 05055982770897
• UDI-Public: (01)05055982770897(10)2002845102(11)251021
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 09/04/2026

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: Other
• Device Model Number: MFA1000M-XL-L1
• Device Lot Number: 2002845102
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/21/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/13/2026
• Supplement Report FDA Received Date: 09/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/21/2025
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown