PROFORE 18-25CM ANKLE CIRC. Case 8 66000016Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 05031844000746), received between Aug 19, 2020 and Mar 23, 2022 — classified as 1 injury, 18 malfunctions.

The most frequently reported specific device problem is “Failure to Unfold or Unwrap” (12 reports).

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 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 23, 2022Contamination; Contamination

  IT WAS REPORTED THAT, THE BLACK AND WHITE DOTS WERE FOUND ON THE 4TH LAYER OF PROFORE 18-25CM ANKLE CIRC. CASE 8. PATIENT WAS CONCERNED THE SAFETY OF THIS PROFORE 4TH LAYER. THE PROCEDURE WAS COMPLETED WITHOUT DELAY USING A S+N BACK-UP DEVICE. PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13865445 ↗
• MalfunctionFeb 1, 2022Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare

  IT WAS REPORTED THAT THE CUSTOMER PROVIDED FEEDBACK STATING THAT THIS BATCH OF PROFORE 18-25CM ANKLE CIRC. CASE 8 THAT THEY RECENTLY ORDERED HAS ISSUE. AFTER FURTHER DISCUSSION, THEY COMPLAINED THAT CERTAIN PART OF THE 4TH LAYER #4 FLEXIBLE COHESIVE BANDAGE LAYER, FOR THE RECENT BATCH RECEIVED, HAS STICK AND CRUMPLED TOGETHER. THEY HAD DIFFICULTY TO STRETCH THE LAYER WHEN FORCE IS APPLIED, THE #4 LAYER LOSS ITS STRETCHABLE TENSION. THEY DIDN'T REPLACE THE #4 LAYER BUT CONTINUE TO USE ON PATIENT. ALTHOUGH NO HARM WAS CAUSE TO PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13415375 ↗
• MalfunctionNov 10, 2021Product Quality Problem; Product Quality Problem

  IT WAS REPORTED THAT, DURING SET UP FOR TREATMENT, THE FOURTH (4) LAYER OF A PROFORE 18-25CM ANKLE CIRC. CASE 8 WAS TOO FRAGILE, AND TORE OFF EASILY WHILE CLINICIAN TRIED TO PULL OUT THE LAYER. TREATMENT WAS PERFORMED, AFTER A NON-SIGNIFICANT DELAY, WITH A BACK-UP DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12787089 ↗
• MalfunctionNov 7, 2021Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT, THE 4TH LAYER OF A PROFORE 18-25CM ANKLE CIRC. CASE 8 IS VERY HARD TO PULL OUT AND TO ROLL ON PATIENTS¿ LEGS. THE ADHESIVENESS OF 4TH LAYER IS VERY TIGHT. IT IS UNKNOWN WHETHER THIS PROBLEM WAS NOTICED IN A THERAPEUTIC ENVIRONMENT OR NOT; THEREFORE, PATIENT INVOLVEMENT HAS NOT BEEN CONFIRMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12759580 ↗
• MalfunctionOct 22, 2021Failure to Unfold or Unwrap; Material Split, Cut or Torn; Failure to Unfold or Unwrap; Material Split, Cut or Torn

  IT WAS REPORTED THAT, THE 4TH LAYER OF TWO PROFORE 18-25CM ANKLE CIRC. CASE 8 IS VERY HARD TO PULL OUT AND TO ROLL ON PATIENTS¿ LEGS. EVENTUALLY THIS 4TH LAYER WAS TORN DUE TO CLINICIAN HAD TO USE FORCE TO PULL IT OUT. THE ADHESIVENESS OF 4TH LAYER IS VERY TIGHT COMPARES WITH OTHER BATCHES. CLINICIANS CONCERN THAT THIS MIGHT AFFECT THE COMPRESSION PRESSURE AND TREATMENT OUTCOMES. IT CONSUMES HUGE NURSING TIME AND MIGHT NOT ACHIEVE DESIRABLE COMPRESSION PRESSURE TOO. AS THESE WERE NOTICED DURING A SET UP OR INSPECTION, PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12681119 ↗
• MalfunctionOct 19, 2021Failure to Unfold or Unwrap; Material Split, Cut or Torn; Failure to Unfold or Unwrap; Material Split, Cut or Torn

  IT WAS REPORTED THAT, THE 4TH LAYER OF TWO PROFORE 18-25CM ANKLE CIRC. CASE 8 IS VERY HARD TO PULL OUT AND TO ROLL ON PATIENTS¿ LEGS. EVENTUALLY THIS 4TH LAYER WAS TORN DUE TO CLINICIAN HAD TO USE FORCE TO PULL IT OUT. THE ADHESIVENESS OF 4TH LAYER IS VERY TIGHT COMPARES WITH OTHER BATCHES. CLINICIANS CONCERN THAT THIS MIGHT AFFECT THE COMPRESSION PRESSURE AND TREATMENT OUTCOMES. IT CONSUMES HUGE NURSING TIME AND MIGHT NOT ACHIEVE DESIRABLE COMPRESSION PRESSURE TOO. AS THESE WERE NOTICED DURING A SET UP OR INSPECTION, PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12657978 ↗
• MalfunctionOct 19, 2021Failure to Unfold or Unwrap; Failure to Unfold or Unwrap

  IT WAS REPORTED THAT, DURING TREATMENT, FIVE BOXES OF PROFORE 18-25CM ANKLE CIRC. CASE 8 HAD THE 4TH LAYER VERY HARD TO PULL OUT AND ROLL ON THE PATIENT'S LEGS. THIS OCCURRED IN 5 PATIENTS. ALSO, EVENTUALLY SOME OF THIS 4TH LAYER WERE TORN DUE TO CLINICIANS HAD TO USE FORCE TO PULL IT OUT. IT OCCURRED RANDOMLY FOR THIS BATCH. CLINICIANS CONCERN THAT THIS MIGHT AFFECT THE COMPRESSION PRESSURE AND TREATMENT OUTCOMES. IT CONSUMES HUGE NURSING TIME AND MIGHT NOT ACHIEVE DESIRABLE COMPRESSION PRESSURE TOO. THIS HAPPENED BEFORE USE IN PATIENT. TREATMENT WAS PERFORMED, WITH A DELAY LESS THAN OR EQUAL TO 30MINS, WITH A SMITH AND NEPHEW BACK-UP DEVICE INSTEAD. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12657870 ↗
• MalfunctionOct 19, 2021Failure to Unfold or Unwrap; Failure to Unfold or Unwrap

  IT WAS REPORTED THAT, DURING TREATMENT, ONE BOX OF PROFORE 18-25CM ANKLE CIRC. CASE 8 HAD THE 4TH LAYER VERY HARD TO PULL OUT AND ROLL ON THE PATIENT'S LEGS. ALSO, EVENTUALLY SOME OF THIS 4TH LAYER WERE TORN DUE TO CLINICIANS HAD TO USE FORCE TO PULL IT OUT. IT OCCURRED RANDOMLY FOR THIS BATCH. CLINICIANS CONCERN THAT THIS MIGHT AFFECT THE COMPRESSION PRESSURE AND TREATMENT OUTCOMES. IT CONSUMES HUGE NURSING TIME AND MIGHT NOT ACHIEVE DESIRABLE COMPRESSION PRESSURE TOO. THIS HAPPENED BEFORE USE IN PATIENT. TREATMENT WAS PERFORMED, WITH A DELAY LESS THAN OR EQUAL TO 30MINS, WITH A SMITH AND NEPHEW BACK-UP DEVICE INSTEAD. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12657793 ↗
• MalfunctionOct 19, 2021Failure to Unfold or Unwrap; Failure to Unfold or Unwrap

  IT WAS REPORTED THAT, DURING TREATMENT, ONE BOX OF PROFORE 18-25CM ANKLE CIRC. CASE 8 HAD THE 4TH LAYER VERY HARD TO PULL OUT AND ROLL ON THE PATIENT'S LEGS. ALSO, EVENTUALLY SOME OF THIS 4TH LAYER WERE TORN DUE TO CLINICIANS HAD TO USE FORCE TO PULL IT OUT. IT OCCURRED RANDOMLY FOR THIS BATCH. CLINICIANS CONCERN THAT THIS MIGHT AFFECT THE COMPRESSION PRESSURE AND TREATMENT OUTCOMES. IT CONSUMES HUGE NURSING TIME AND MIGHT NOT ACHIEVE DESIRABLE COMPRESSION PRESSURE TOO. THIS HAPPENED BEFORE USE IN PATIENT. TREATMENT WAS PERFORMED, WITH A DELAY LESS THAN OR EQUAL TO 30MINS, WITH A SMITH AND NEPHEW BACK-UP DEVICE INSTEAD. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12657705 ↗
• MalfunctionOct 19, 2021Failure to Unfold or Unwrap; Failure to Unfold or Unwrap

  IT WAS REPORTED THAT, DURING TREATMENT, ONE BOX OF PROFORE 18-25CM ANKLE CIRC. CASE 8 HAD THE 4TH LAYER VERY HARD TO PULL OUT AND ROLL ON THE PATIENT'S LEGS. ALSO, EVENTUALLY SOME OF THIS 4TH LAYER WERE TORN DUE TO CLINICIANS HAD TO USE FORCE TO PULL IT OUT. IT OCCURRED RANDOMLY FOR THIS BATCH. CLINICIANS CONCERN THAT THIS MIGHT AFFECT THE COMPRESSION PRESSURE AND TREATMENT OUTCOMES. IT CONSUMES HUGE NURSING TIME AND MIGHT NOT ACHIEVE DESIRABLE COMPRESSION PRESSURE TOO. THIS HAPPENED BEFORE USE IN PATIENT. TREATMENT WAS PERFORMED, WITH A DELAY LESS THAN OR EQUAL TO 30MINS, WITH A SMITH AND NEPHEW BACK-UP DEVICE INSTEAD. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12657525 ↗
• MalfunctionOct 19, 2021Failure to Unfold or Unwrap; Failure to Unfold or Unwrap

  IT WAS REPORTED THAT, DURING TREATMENT, ONE BOX OF PROFORE 18-25CM ANKLE CIRC. CASE 8 HAD THE 4TH LAYER VERY HARD TO PULL OUT AND ROLL ON THE PATIENT'S LEGS. ALSO, EVENTUALLY SOME OF THIS 4TH LAYER WERE TORN DUE TO CLINICIANS HAD TO USE FORCE TO PULL IT OUT. IT OCCURRED RANDOMLY FOR THIS BATCH. CLINICIANS CONCERN THAT THIS MIGHT AFFECT THE COMPRESSION PRESSURE AND TREATMENT OUTCOMES. IT CONSUMES HUGE NURSING TIME AND MIGHT NOT ACHIEVE DESIRABLE COMPRESSION PRESSURE TOO. THIS HAPPENED BEFORE USE IN PATIENT. TREATMENT WAS PERFORMED, WITH A DELAY LESS THAN OR EQUAL TO 30MINS, WITH A SMITH AND NEPHEW BACK-UP DEVICE INSTEAD. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12657435 ↗
• MalfunctionOct 11, 2021Product Quality Problem; Failure to Unfold or Unwrap; Product Quality Problem; Failure to Unfold or Unwrap

  IT WAS REPORTED THAT, DURING TREATMENT, IN FOUR BOXES OF PROFORE 18-25CM ANKLE CIRC. CASE 8, THE 4TH LAYER WAS VERY HARD TO PULL OUT AND TO ROLL ON PATIENTS¿ LEGS, THE ADHESIVENESS WAS VERY TIGHT COMPARES WITH OTHER BATCHES. IT WAS ALSO REPORTED THAT THE QUALITY WAS NOT CONSISTENT, THE DIAMETER OF THIS LAYER ROLL WAS DIFFERENT INDIVIDUALLY. IT IS UNKNOWN HOW TREATMENT WAS COMPLETED. NO HARM TO THE PATIENT OR ANY FURTHER COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12606644 ↗
• MalfunctionOct 11, 2021Product Quality Problem; Failure to Unfold or Unwrap; Product Quality Problem; Failure to Unfold or Unwrap

  IT WAS REPORTED THAT, DURING TREATMENT, IN FOUR BOXES OF PROFORE 18-25CM ANKLE CIRC. CASE 8, THE 4TH LAYER WAS VERY HARD TO PULL OUT AND TO ROLL ON PATIENTS¿ LEGS, THE ADHESIVENESS WAS VERY TIGHT COMPARES WITH OTHER BATCHES. IT WAS ALSO REPORTED THAT THE QUALITY WAS NOT CONSISTENT, THE DIAMETER OF THIS LAYER ROLL WAS DIFFERENT INDIVIDUALLY. IT IS UNKNOWN HOW TREATMENT WAS COMPLETED. NO HARM TO THE PATIENT OR ANY FURTHER COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12606609 ↗
• MalfunctionOct 11, 2021Product Quality Problem; Failure to Unfold or Unwrap; Product Quality Problem; Failure to Unfold or Unwrap

  IT WAS REPORTED THAT, DURING TREATMENT, IN FOUR BOXES OF PROFORE 18-25CM ANKLE CIRC. CASE 8, THE 4TH LAYER WAS VERY HARD TO PULL OUT AND TO ROLL ON PATIENTS¿ LEGS, THE ADHESIVENESS WAS VERY TIGHT COMPARES WITH OTHER BATCHES. IT WAS ALSO REPORTED THAT THE QUALITY WAS NOT CONSISTENT, THE DIAMETER OF THIS LAYER ROLL WAS DIFFERENT INDIVIDUALLY. IT IS UNKNOWN HOW TREATMENT WAS COMPLETED. NO HARM TO THE PATIENT OR ANY FURTHER COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12606495 ↗
• MalfunctionOct 11, 2021Product Quality Problem; Failure to Unfold or Unwrap; Product Quality Problem; Failure to Unfold or Unwrap

  IT WAS REPORTED THAT, DURING TREATMENT, IN FOUR BOXES OF PROFORE 18-25CM ANKLE CIRC. CASE 8, THE 4TH LAYER WAS VERY HARD TO PULL OUT AND TO ROLL ON PATIENTS¿ LEGS, THE ADHESIVENESS WAS VERY TIGHT COMPARES WITH OTHER BATCHES. IT WAS ALSO REPORTED THAT THE QUALITY WAS NOT CONSISTENT, THE DIAMETER OF THIS LAYER ROLL WAS DIFFERENT INDIVIDUALLY. IT IS UNKNOWN HOW TREATMENT WAS COMPLETED. NO HARM TO THE PATIENT OR ANY FURTHER COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12606452 ↗
• MalfunctionSep 28, 2021Material Too Rigid or Stiff; Failure to Unfold or Unwrap; Material Too Rigid or Stiff; Failure to Unfold or Unwrap

  IT WAS REPORTED THAT BEFORE TREATMENT WITH A PROFORE 18-25CM ANKLE CIRC. CASE 8 THE MATERIAL IS VERY HARD TO PULL OUT AND TO ROLL ON THE PATIENT LEG. ALSO THE ADHESIVENESS IS VERY TIGHT COMPARED TO OTHER BATCHES, WHICH MIGHT AFFECT THE COMPRESSION PRESSURE AND PATIENT OUTCOME. THE THERAPY WAS COMPLETED WITH THE SAME PRODUCT, REQUIRING IT TO BE PULL OUT AND TRIMMED PART BY PART TO ACHIEVE THE COMPRESSION PRESSURE. NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12539752 ↗
• MalfunctionSep 8, 2020Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT DURING TREATMENT THE PROFORE 18-25CM ANKLE CIRC. CASE 8 LIGHT CONFORMABLE BANDAGE WAS NO ROLLED NEATLY. THE TREATMENT FINISHED WITH A SMITH AND NEPHEW BACKUP DEVICE. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10505105 ↗
• InjurySep 8, 2020Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT THE PROFORE 18-25CM ANKLE CIRC. CASE8. FLEXIBLE COHESIVE BANDAGE WAS CRUMPLED WHEN CLINICIAN BANDAGED PATIENT¿S FOOT, DURING TREATMENT. THIS ISSUE WAS COMPLETED BY A COMPETITORS DEVICE. NO INJURY REPORTED. NO DELAY REPORTED

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10504924 ↗
• MalfunctionAug 19, 2020Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT, FOURTH LAYER OF PROFORE 18-25CM ANKLE CIRC IS NOT ROLLING OUT OR MALFORMED (SHREDDED). A BACKUP DEVICE WAS USED. INFORMATION OF THE PATIENT IS UNKNOWN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10426094 ↗