MAUDE Adverse Event Report: ORTHO & SURGICAL PRODUCTS ENTERPRISES S.A. SHOULDER IMMOBILIZER, XXL; SLING, ARM

Model Number	A111009
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Hypersensitivity/Allergic reaction (1907); Burning Sensation (2146); Blister (4537)
Date of Event	08/29/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
An end user reported, "patient had an allergic reaction to the bicep cuff.".
Additional Manufacturer Narrative
An end consumer reported, "patient had an allergic reaction to the bicep cuff." deroyal industries inc.Requested the return of the device, however, it was unavailable to be returned.Deroyal reviewed the specifications as well as the work order for the lot of the shoulder imobilizer involved in the complaint and found no issues.Work in process was also reviewed and no issues were found within those records or inspections.The quality control inspection report was also reviewed.Eight units were randomly checked during the random inspections; all were found to be within specification and acceptable.Because of the nature of the reported complaint, an inventory check would not provide outputs for the investigation.A complaint to sales ratio was conducted between january of 2023 to september of 2025 and found to be (b)(4).Root cause: because the sample was unavailable for return and no issues were found in the production records, the root cause was unable to be determined.Corrective and preventive actions: because the root cause was unable to be determined, no corrective or preventive actions were taken.Deroyal will continue to monitor for trends around this item and issue.This investigation is complete at this time.No further information is available at this time.We will provide follow-up report if additional information becomes available.

• Brand Name: SHOULDER IMMOBILIZER, XXL
• Common Device Name: SLING, ARM
• Manufacturer (Section D): ORTHO & SURGICAL PRODUCTS ENTERPRISES S.A.; km 20.5 carretera a villa; zona 3 finca; morancito, villa canales 01065 ; GT 01065
• Manufacturer (Section G): ORTHO & SURGICAL PRODUCTS ENTERPRISES S.A.; km 20.5 carretera a villa; zona 3 finca; morancito, villa canales 01065 ; GT 01065
• Manufacturer Contact: reagan facemire ; 200 debusk lane; powell, TN 37849 ; 8653622106
• MDR Report Key: 23017347
• Report Number: 3010452421-2025-00001
• Device Sequence Number: 9573056
• Product Code: ILI
• UDI-Device Identifier: 00749756611763
• UDI-Public: 00749756611763
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/10/2025

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?: No
• Operator of Device: Lay User/Patient
• Device Model Number: A111009
• Device Lot Number: 62366796
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/29/2025
• Initial Report FDA Received Date: 09/10/2025
• 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): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown