MAUDE Adverse Event Report: Ortho & Surgical Products Enterprises S.A. Knee Immobilizer, Cutaway, 19IN; JOINT, KNEE, EXTERNAL BRACE

Model Number	ER4433-19
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Necrosis (1971); Blister (4537)
Date of Event	08/04/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
A end consumer reported, "i am reaching out to report a potential adverse effect that may be potentially associated with one of your products, the 19" knee immobilizer (ref er4433-19, lot 63307667 (second patient) ; lot 63351924 (third patient)).We have now had two separate cardiac surgery patients who required intra-aortic balloon pump placement and subsequently developed significant blistering and skin necrosis on the lower extremity of the immobilized leg.Both patients were using the same foam-based immobilizer model.In each case, the skin injury progressed to large bullae and one experienced full-thickness necrosis requiring advanced wound care.Biopsy confirmed skin necrosis in the second patient rather than an inflammatory or systemic dermatologic process.No friction, shear, or moisture-related issues were identified, and the immobilizers appeared to be applied correctly.".
Additional Manufacturer Narrative
A end consumer reported, "i am reaching out to report a potential adverse effect that may be potentially associated with one of your products, the 19" knee immobilizer (ref er4433-19, lot 63307667 (second patient) ; lot 63351924 (third patient)).We have now had two separate cardiac surgery patients who required intra-aortic balloon pump placement and subsequently developed significant blistering and skin necrosis on the lower extremity of the immobilized leg.Both patients were using the same foam-based immobilizer model.In each case, the skin injury progressed to large bullae and one experienced full-thickness necrosis requiring advanced wound care.Biopsy confirmed skin necrosis in the second patient rather than an inflammatory or systemic dermatologic process.No friction, shear, or moisture-related issues were identified, and the immobilizers appeared to be applied correctly." deroyal industries, inc.Requested return of the device, however, it was listed as unavailable.This investigation is not complete at this time.No further information is available at this time.We will provide follow-up report when additional information becomes available.

• Brand Name: Knee Immobilizer, Cutaway, 19IN
• Common Device Name: JOINT, KNEE, EXTERNAL BRACE
• 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 ; +1(865)362-2106
• MDR Report Key: 50193839
• Report Number: 3010452421-2026-00009
• Device Sequence Number: 9887185
• Product Code: ITQ
• UDI-Device Identifier: 00749756089760
• UDI-Public: 00749756089760
• 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,Followup
• Report Date (Section B): 09/23/2026

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: Health Professional
• Device Model Number: ER4433-19
• Device Lot Number: 63351924
• 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: 08/04/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/10/2026
• Supplement Report FDA Received Date: 09/23/2026
• 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): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown