PROFORE KIT LF ANKLE CIRC 18-25CM Case 8 66000770Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05031844013876), received between Jul 23, 2021 and Feb 16, 2022 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Device Difficult to Setup or Prepare” (1 report).

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. What reports can and can't tell you · How this data works · Data updated Oct 18, 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.

• MalfunctionFeb 16, 2022Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare

  IT WAS REPORTED THAT IT IS NOT POSSIBLE TO UNROLL COBAN LAYER OF TEN (10) PROFORE KIT LF ANKLE CIRC 18-25CM CASE 8 AS IT IS STICKING ON ITSELF, TEARING AND CREATING AN UNEVEN COMPRESSION LAYER APPLICATION. IT IS UNKNOWN IF THIS WAS NOTICED UPON INSPECTION OR WHILE SETTING UP FOR TREATMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13540356 ↗
• InjuryJul 23, 2021Failure to Unfold or Unwrap; Adverse Event Without Identified Device or Use Problem; Failure to Unfold or Unwrap; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, THE USE OF AN COMPLAINED UNKN PROFORE MAY HAVE CAUSED A CLINIC NURSE TO BE CURRENTLY OFF OF WORK BECAUSE OF AN INJURY. IT IS UNKNOWN HOW WAS THIS INJURY ADDRESSED, THE TYPE OF THE INJURY AND THE CURRENT STATE OF THE NURSE.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Unspecified Tissue Injury

  MAUDE report 12217061 ↗