PROCARE
Received Apr 24, 2026 · Event occurred Apr 1, 2026
Report 9616086-2026-00015 · MDR key 24990884
Device
Product problems
- Patient Device Interaction Problem
Patient
NA · Unknown
- Abrasion
Narrative
Description of Event or Problem
IT WAS REPORTED THAT THE HINGE OF THE BRACE POPPED THROUGH THE STITCHING OF THE MATERIAL RUBBING THE PATIENTS LEG CAUSING THE PATIENT TO BLEED, THE PATIENT SOUGHT MEDICAL ATTENTION AND RECEIVED FIST AID.
Additional Manufacturer Narrative
IT WAS REPORTED THAT THE HINGE OF THE BRACE POPPED THROUGH THE STITCHING OF THE MATERIAL RUBBING THE PATIENTS LEG CAUSING THE PATIENT TO BLEED, THE PATIENT SOUGHT MEDICAL ATTENTION AND RECEIVED FIRST AID. THE BRACE WAS NOT RETURNED FOR EVALUATION DUE TO THE PATIENT'S BLOOD ON THE BRACE, PHOTOS OF THE INJURY WERE ALSO NOT PROVIDED. IT WAS STATED THAT THE PATIENT WAS HEALING WELL BUT NO OTHER INFORMATION WAS PROVIDED. THE ROOT CAUSE COULD NOT BE ESTABLISHED. IF ADDITIONAL INFORMATION ON THIS REPORTED EVENT BECOMES AVAILABLE THIS INVESTIGATION WILL BE REEVALUATED AND A SUPPLEMENTAL REPORT WILL BE SUBMITTED.