DeRoyal ER4433-19Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00749756089760), received between Aug 10, 2026 and Aug 10, 2026 — classified as 2 injuries.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryAug 10, 2026Adverse Event Without Identified Device or Use Problem

  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."

  Patient problems: Blister; Necrosis

  MAUDE report 50193839 ↗
• InjuryAug 10, 2026Adverse Event Without Identified Device or Use Problem

  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 (b)(4), 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."

  Patient problems: Blister; Necrosis

  MAUDE report 50193834 ↗