PROFORE LITE SYSTEM KIT Case 8 66000415Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 05031844002498), received between Sep 28, 2020 and Feb 10, 2022 — classified as 14 malfunctions.

The most frequently reported specific device problem is “Device Difficult to Setup or Prepare” (7 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 16, 2026.

Most reported problems

Recent adverse event reports

The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 10, 2022Device Difficult to Setup or Prepare; Material Split, Cut or Torn; Device Difficult to Setup or Prepare; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE 4TH LAYER IN FIVE LOTS OF PROFORE LITE SYSTEM KIT CASE 8 IS BEING TOO TIGHT TO PULL APART. THIS IS CAUSING RIPPING AS TRYING TO APPLY AND ALSO THERE ARE PRESENCE OF PIN HOLES/TEARS IN THEM. THIS WAS NOTICED DURING TREATMENT SET UP CAUSING A DELAY LESS THAN 30 MIN, ENDING UP USING A S+N BACK UP DRESSING. PATIENT WAS NOT IMPACTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13505055 ↗
• MalfunctionFeb 9, 2022Device Difficult to Setup or Prepare; Material Split, Cut or Torn; Device Difficult to Setup or Prepare; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE 4TH LAYER IN A PROFORE LITE SYSTEM KIT CASE 8 IS BEING TOO TIGHT TO PULL APART. THIS IS CAUSING RIPPING AS TRYING TO APPLY AND ALSO THERE ARE PRESENCE OF PIN HOLES/TEARS IN IT. THIS WAS NOTICED DURING TREATMENT SET UP CAUSING A DELAY LESS THAN 30 MIN, ENDING UP USING A S+N BACK UP DRESSING. PATIENT WAS NOT IMPACTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13502063 ↗
• MalfunctionFeb 9, 2022Device Difficult to Setup or Prepare; Material Split, Cut or Torn; Device Difficult to Setup or Prepare; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE 4TH LAYER IN A PROFORE LITE SYSTEM KIT CASE 8 IS BEING TOO TIGHT TO PULL APART. THIS IS CAUSING RIPPING AS TRYING TO APPLY AND ALSO THERE ARE PRESENCE OF PIN HOLES/TEARS IN IT. THIS WAS NOTICED DURING TREATMENT SET UP CAUSING A DELAY LESS THAN 30 MIN, ENDING UP USING A S+N BACK UP DRESSING. PATIENT WAS NOT IMPACTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13502054 ↗
• MalfunctionFeb 9, 2022Device Difficult to Setup or Prepare; Material Split, Cut or Torn; Device Difficult to Setup or Prepare; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE 4TH LAYER IN A PROFORE LITE SYSTEM KIT CASE 8 IS BEING TOO TIGHT TO PULL APART. THIS IS CAUSING RIPPING AS TRYING TO APPLY AND ALSO THERE ARE PRESENCE OF PIN HOLES/TEARS IN IT. THIS WAS NOTICED DURING TREATMENT SET UP CAUSING A DELAY LESS THAN 30 MIN, ENDING UP USING A S+N BACK UP DRESSING. PATIENT WAS NOT IMPACTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13502030 ↗
• MalfunctionFeb 9, 2022Device Difficult to Setup or Prepare; Material Split, Cut or Torn; Device Difficult to Setup or Prepare; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE 4TH LAYER IN FIVE LOTS OF PROFORE LITE SYSTEM KIT CASE 8 IS BEING TOO TIGHT TO PULL APART. THIS IS CAUSING RIPPING AS TRYING TO APPLY AND ALSO THERE ARE PRESENCE OF PIN HOLES/TEARS IN THEM. THIS WAS NOTICED DURING TREATMENT SET UP CAUSING A DELAY LESS THAN 30 MIN, ENDING UP USING A S+N BACK UP DRESSING. PATIENT WAS NOT IMPACTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13502006 ↗
• MalfunctionNov 30, 2021Failure to Unfold or Unwrap; Failure to Unfold or Unwrap

  IT WAS REPORTED, THE COBAN LAYER OF FIFTEEN (15) PROFORE LITE SYSTEM KIT CASE 8 ARE SO TIGHT IT'S VERY DIFFICULT TO GET A PROPER WRAP, THEREFORE, IS IMPACTING THE ABILITY TO USE. THIS PROBLEM WAS NOTICED BEFORE TREATMENT AND A BACK UP WAS AVAILABLE; THEREFORE, PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12892929 ↗
• MalfunctionNov 30, 2021Failure to Unfold or Unwrap; Failure to Unfold or Unwrap

  IT WAS REPORTED, THE COBAN LAYER OF FIFTEEN (15) PROFORE LITE SYSTEM KIT CASE 8 ARE SO TIGHT IT'S VERY DIFFICULT TO GET A PROPER WRAP, THEREFORE, IS IMPACTING THE ABILITY TO USE. THIS PROBLEM WAS NOTICED BEFORE TREATMENT AND A BACK UP WAS AVAILABLE; THEREFORE, PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12892905 ↗
• MalfunctionNov 11, 2021Failure to Unfold or Unwrap; Failure to Unfold or Unwrap

  IT WAS REPORTED, THE COBAND LAYER OF PROFORE LITE SYSTEM KIT CASE 8 ARE SO TIGHT IT'S VERY DIFFICULT TO GET A PROPER WRAP, THEREFORE, IS IMPACTING THE ABILITY TO USE. IT IS UNKNOWN WHETHER THIS PROBLEM WAS NOTICED IN A THERAPEUTIC ENVIRONMENT OR NOT; THEREFORE, PATIENT INVOLVEMENT HAS NOT BEEN CONFIRMED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12799070 ↗
• MalfunctionNov 11, 2021Failure to Unfold or Unwrap; Failure to Unfold or Unwrap

  IT WAS REPORTED, THE COBAND LAYER OF PROFORE LITE SYSTEM KIT CASE 8 ARE SO TIGHT IT'S VERY DIFFICULT TO GET A PROPER WRAP, THEREFORE, IS IMPACTING THE ABILITY TO USE. IT IS UNKNOWN WHETHER THIS PROBLEM WAS NOTICED IN A THERAPEUTIC ENVIRONMENT OR NOT; THEREFORE, PATIENT INVOLVEMENT HAS NOT BEEN CONFIRMED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12798651 ↗
• MalfunctionNov 7, 2021Failure to Unfold or Unwrap; Material Deformation; Physical Resistance/Sticking; Failure to Unfold or Unwrap; Material Deformation; Physical Resistance/Sticking

  IT WAS REPORTED THAT THE BROWN BANDAGE OF A PROFORE LITE SYSTEM KIT CASE 8 LITE MULTI-LAYER COMPRESSION BANDAGE SYSTEM STICKS AND THE COMPRESSION PRESSURE CANNOT BE BUILT UP PROFESSIONALLY. THE DEVICE IS ALSO VERY WRINKLED AND CANNOT BE ROLLED OUT PROPERLY. TREATMENT WAS PERFORMED, WITHOUT ANY DELAY, WITH THE SAME DEVICE. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12760250 ↗
• MalfunctionNov 4, 2021Difficult to Fold, Unfold or Collapse; Failure to Unfold or Unwrap; Physical Resistance/Sticking; Difficult to Fold, Unfold or Collapse; Failure to Unfold or Unwrap; Physical Resistance/Sticking

  IT WAS REPORTED THAT A THE #4 ROLL OF PROFORE LITE SYSTEM KIT CASE 8 LITE MULTI-LAYER COMPRESSION BANDAGE SYSTEM COULD NOT BE UNROLLED LIKE NORMAL IT HAD STRONG ADHESIONS. 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 12751382 ↗
• MalfunctionOct 1, 2021Difficult to Fold, Unfold or Collapse; Device Difficult to Setup or Prepare; Difficult to Fold, Unfold or Collapse; Device Difficult to Setup or Prepare

  IT WAS REPORTED THAT A PROFORE LITE SYSTEM KIT CASE 8 #4 BANDAGE COHESIVE OUTER LAYER DOES NOT UNROLL EASILY FROM THE ROLL. IS BADLY ROLLED, WITH OVERLAPS AND WRINKLES THAT MAKE IT IMPOSSIBLE TO APPLY. NO CASE INVOLVED, THEREFORE NO PATIENT WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12565010 ↗
• MalfunctionMay 26, 2021Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT, DURING TREATMENT WITH A BOX OF PROFORE LITE SYSTEM KIT CASE 8. THE DRESSING WILL NOT UNWIND FROM THE ROLL. THE INDIVIDUAL LAYERS WERE TIGHTLY GLUED TO ONE ANOTHER. IT WAS UNKNOWN HOW THE PROCEDURE WAS FINISHED. PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11882906 ↗
• MalfunctionSep 28, 2020Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare

  IT WAS REPORTED THAT THE CUSTOMER NOTIFIED US THAT IT SEEMS THAT THE QUALITY OF LAYER 4 COHESIVE LAYER HAS BEEN CHANGED. SINCE A WHILE, IT IS MUCH HARDER TO ROLL OFF THE BANDAGE FROM THE ROLL, LEADING TO A MORE COMPLICATED APPLICATION. NO HARM OR INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10593851 ↗