PROFORE KIT LATEX FREE 66020626Recalls & reported problems

Summary

The FDA's MAUDE database contains 45 adverse event reports that list this exact device (DI 05031844013883), received between Jun 18, 2020 and Feb 23, 2022 — classified as 45 malfunctions.

The most frequently reported specific device problem is “Material Integrity Problem” (11 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 25 most recent of 45 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 23, 2022Material Too Rigid or Stiff; Material Too Rigid or Stiff

  IT WAS REPORTED THAT THE 4TH LAYER OF PROFORE WAS DIFFICULT TO UNWRAP. TREATMENT WAS COMPLETED AFTER A NON-SIGNIFICANT DELAY, WITH A BACK-UP DEVICE. NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13585147 ↗
• MalfunctionFeb 9, 2022Material Puncture/Hole; Physical Resistance/Sticking; Material Puncture/Hole; Physical Resistance/Sticking

  IT WAS REPORTED THAT TWENTY SEVEN (27) PROFORE KIT LATEX FREE ARE SUPER STICKY AND HARD TO PULL OFF THE ROLL AS IF THEY WERE SUPER GLUED. THEY ARE ALSO RIPPING AND HAVE HOLES. TREATMENT WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, WITH A COMPETITOR'S BACK-UP DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13501909 ↗
• MalfunctionFeb 1, 2022Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT WHILE OPENING THE PROFORE KIT LFF CASE 8, THE COBAN LAYER WAS SUPER STICKY. BY TRYING TO PULL LAYER OFF ROLL CAUSED HOLE IN WRAP. NO PATIENT WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13415407 ↗
• MalfunctionJan 27, 2022Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT, DURING TREATMENT, THERE WAS A FAILURE WITH THE FOURTH LAYER OF THREE PROFORE KIT LFF CASE 8. A HOLE DEVELOPED AS THE PRODUCTS WERE UNROLLED DURING APPLICATION OF THE FINAL COMPRESSION LAYER. THE TREATMENT WAS CONTINUED WITH SMITH AND NEPHEW BACKUP DRESSINGS WITHOUT SIGNIFICANT DELAYS. THE PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13375078 ↗
• MalfunctionJan 27, 2022Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT, DURING TREATMENT, THERE WAS A FAILURE WITH THE FOURTH LAYER OF THE PROFORE KIT LFF CASE 8. A HOLE DEVELOPED AS THE PRODUCTS WERE UNROLLED DURING APPLICATION OF THE FINAL COMPRESSION LAYER. THE TREATMENT WAS CONTINUED WITH SMITH AND NEPHEW BACKUP DRESSINGS WITHOUT SIGNIFICANT DELAYS. THE PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13375074 ↗
• MalfunctionJan 27, 2022Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT, DURING TREATMENT, THERE WAS A FAILURE WITH THE FOURTH LAYER OF THREE PROFORE KIT LFF CASE 8. A HOLE DEVELOPED AS THE PRODUCTS WERE UNROLLED DURING APPLICATION OF THE FINAL COMPRESSION LAYER. THE TREATMENT WAS CONTINUED WITH SMITH AND NEPHEW BACKUP DRESSINGS WITHOUT SIGNIFICANT DELAYS. THE PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13374965 ↗
• MalfunctionJan 27, 2022Failure to Unfold or Unwrap; Physical Resistance/Sticking; Failure to Unfold or Unwrap; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING TREATMENT, THE PROFORE KIT LFF CASE 8 PRESENTED STICKING AND WAS HARD TO UNROLL. THERE WAS A DELAY 30 MINUTES OR LESS AND THE PROCEDURE WAS FINISHED USING A SMITH & NEPHEW BACK UP. PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13372415 ↗
• MalfunctionDec 15, 2021Difficult to Fold, Unfold or Collapse; Nonstandard Device; Difficult to Fold, Unfold or Collapse; Nonstandard Device

  IT WAS REPORTED THAT, DURING TREATMENT, A PROFORE KIT LATEX FREE MULTI-LAYER COMPRESSION BANDAGING SYSTEM WAS NOT PULLING APART LIKE NORMAL. TREATMENT WAS RESUMED, 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 13014293 ↗
• MalfunctionNov 11, 2021Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT, DURING TREATMENT, THE LAST 1/4TH PART OF A PROFORE ROLL WAS SO TIGHT THAT IT COULD NOT BE UNWIND TO GET IT OFF TO APPLY TO PATIENT. TOO MUCH TENSION WAS OBSERVED. TREATMENT WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, WITH A SMITH & NEPHEW BACK-UP DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12795709 ↗
• MalfunctionNov 9, 2021Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT, DURING TREATMENT, THE COBAN LAYER OF PROFORE WAS WOUND SO TIGHT THAT IT CREATED TOO MUCH TENSION AND WOULD NOT COME OFF THE ROLL ABOUT 3/4TH OF THE WAY IN. TREATMENT WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, WITH A SMITH & NEPHEW BACK-UP DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12779520 ↗
• MalfunctionNov 8, 2021Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT, DURING TREATMENT, THE LAST 1/4TH PART OF THREE (3) PROFORE ROLLS WAS SO TIGHT THAT IT COULD NOT BE UNWIND TO GET IT OFF TO APPLY TO PATIENT. TOO MUCH TENSION WAS OBSERVED. TREATMENT WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, WITH A SMITH & NEPHEW BACK-UP DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12770786 ↗
• MalfunctionNov 7, 2021Failure to Unfold or Unwrap; Failure to Unfold or Unwrap

  IT WAS REPORTED THAT, DURING TREATMENT, THE FOURTH LAYER OF PROFORE KIT LFF CASE 8 WAS TIGHTLY BOUND AND DIFFICULT TO PULL OFF ROLL. TREATMENT WAS PERFORMED WITH A SN BACK-UP DEVICE. NO HARM TO THE PATIENT OR ANY FURTHER COMPLICATION REPORTED. 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 12762406 ↗
• MalfunctionOct 5, 2021Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT, DURING TREATMENT, THE FOURTH LAYER OF A PROFORE KIT LFF CASE 8 BECAME EXTREMELY DIFFICULT TO UNROLL WHEN GETTING DOWN TO THE LAST 1/4 OF THE ROLL. ONCE APART IT WAS STRETCHED OUT AND COULD NOT BE USED. TREATMENT WAS RESUMED, WITH A LESS THAN OR EQUAL TO 30 MINUTES DELAY, WITH A BACK-UP DEVICE. IT IS UNKNOWN IF THIS HAPPENED BEFORE, DURING OR AFTER TREATMENT. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12574080 ↗
• MalfunctionOct 5, 2021Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT, DURING TREATMENT, THE FOURTH LAYER OF A PROFORE KIT LFF CASE 8 BECAME EXTREMELY DIFFICULT TO UNROLL WHEN GETTING DOWN TO THE LAST 1/4 OF THE ROLL. ONCE APART IT WAS STRETCHED OUT AND COULD NOT BE USED. TREATMENT WAS RESUMED, WITH A LESS THAN OR EQUAL TO 30 MINUTES DELAY, WITH A BACK-UP DEVICE. IT IS UNKNOWN IF THIS HAPPENED BEFORE, DURING OR AFTER TREATMENT. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12574049 ↗
• MalfunctionOct 5, 2021Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT, DURING TREATMENT, THE FOURTH LAYER OF A PROFORE KIT LFF CASE 8 BECAME EXTREMELY DIFFICULT TO UNROLL WHEN GETTING DOWN TO THE LAST 1/4 OF THE ROLL. ONCE APART IT WAS STRETCHED OUT AND COULD NOT BE USED. TREATMENT WAS RESUMED, WITH A LESS THAN OR EQUAL TO 30 MINUTES DELAY, WITH A BACK-UP DEVICE. IT IS UNKNOWN IF THIS HAPPENED BEFORE, DURING OR AFTER TREATMENT. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12574044 ↗
• MalfunctionSep 28, 2021Device Difficult to Setup or Prepare; Material Puncture/Hole; Device Difficult to Setup or Prepare; Material Puncture/Hole

  IT WAS REPORTED THAT, DURING A TREATMENT SETUP, ON THREE (3) PROFORE KIT LFF CASE 8 THE LAYER #4, FLEXIBLE COHESIVE BANDAGE, BECOMES INCREASINGLY DIFFICULT TO UNROLL THE FURTHER DOWN THE ROLL IT GETS. PATIENT EXPERIENCES INCREASED TUGGING AS PRODUCT IS APPLIED, AND PRODUCT SOMETIMES FRAYS OR PUNCHES THROUGH WITH HOLES. TREATMENT WAS COMPLETED WITH A BACKUP DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12544328 ↗
• MalfunctionSep 28, 2021Device Difficult to Setup or Prepare; Material Puncture/Hole; Device Difficult to Setup or Prepare; Material Puncture/Hole

  IT WAS REPORTED THAT, DURING A TREATMENT SETUP, ON THREE (3) PROFORE KIT LFF CASE 8 THE LAYER #4, FLEXIBLE COHESIVE BANDAGE, BECOMES INCREASINGLY DIFFICULT TO UNROLL THE FURTHER DOWN THE ROLL IT GETS. PATIENT EXPERIENCES INCREASED TUGGING AS PRODUCT IS APPLIED, AND PRODUCT SOMETIMES FRAYS OR PUNCHES THROUGH WITH HOLES. TREATMENT WAS COMPLETED WITH A BACKUP DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12544303 ↗
• MalfunctionSep 28, 2021Device Difficult to Setup or Prepare; Material Puncture/Hole; Device Difficult to Setup or Prepare; Material Puncture/Hole

  IT WAS REPORTED THAT, DURING A TREATMENT SETUP, ON THREE (3) PROFORE KIT LFF CASE 8 THE LAYER #4, FLEXIBLE COHESIVE BANDAGE, BECOMES INCREASINGLY DIFFICULT TO UNROLL THE FURTHER DOWN THE ROLL IT GETS. PATIENT EXPERIENCES INCREASED TUGGING AS PRODUCT IS APPLIED, AND PRODUCT SOMETIMES FRAYS OR PUNCHES THROUGH WITH HOLES. TREATMENT WAS COMPLETED WITH A BACKUP DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12544301 ↗
• MalfunctionSep 22, 2021Loss of or Failure to Bond; Melted; Loss of or Failure to Bond; Melted

  IT WAS REPORTED THAT, THE FOURTH LAYER OF PROFORE KIT LFF CASE 8, THE COBAN LAYER, IS FINE WHEN INITIALING WRAPPING THE PATIENT LEG BUT THEN IT GETS DOWN TO THE LAST 4TH OF THE COBAN ROLL AND BECOMES DIFFICULT TO CONTINUE WRAPPING BECAUSE THE DRESSINGS IS ALMOST SUPER GLUED/MELTED. TREATMENT WAS FINISHED WITH A BACK UP DEVICE, WITH LESS THAN 30 MINUTES OF DELAY. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12516494 ↗
• MalfunctionSep 16, 2021Loss of or Failure to Bond; Melted; Loss of or Failure to Bond; Melted

  IT WAS REPORTED THAT, THE FOURTH LAYER OF PROFORE KIT LFF CASE 8, THE COBAN LAYER, IS FINE WHEN INITIALING WRAPPING THE PATIENT LEG BUT THEN IT GETS DOWN TO THE LAST 4TH OF THE COBAN ROLL AND BECOMES DIFFICULT TO CONTINUE WRAPPING BECAUSE THE DRESSINGS IS ALMOST SUPER GLUED/MELTED. TREATMENT WAS FINISHED WITH A BACK UP DEVICE, WITH LESS THAN 30 MINUTES OF DELAY. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12482126 ↗
• MalfunctionSep 8, 2021Failure to Unfold or Unwrap; Physical Resistance/Sticking; Failure to Unfold or Unwrap; Physical Resistance/Sticking

  IT WAS REPORTED THAT WHILE APPLYING THE 4TH LAYER OF TWO (2) PROFORE KIT LATEX FREE, THE LAST QUARTER OF THE ROLL BECOMES VERY HARD TO UNROLL, IT SEEMS GLUED/MELTED TOGETHER, SO THAT THEY CAN NOT APPLY IT TO THE PATIENTS LEG, THE NURSE HAD TO CUT THE LAST QUARTER OFF. TREATMENT WAS RESUMED, WITHOUT ANY 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 12443130 ↗
• MalfunctionSep 8, 2021Failure to Unfold or Unwrap; Physical Resistance/Sticking; Failure to Unfold or Unwrap; Physical Resistance/Sticking

  IT WAS REPORTED THAT WHILE APPLYING THE 4TH LAYER OF TWO (2) PROFORE KIT LATEX FREE, THE LAST QUARTER OF THE ROLL BECOMES VERY HARD TO UNROLL, IT SEEMS GLUED/MELTED TOGETHER, SO THAT THEY CAN NOT APPLY IT TO THE PATIENTS LEG, THE NURSE HAD TO CUT THE LAST QUARTER OFF. TREATMENT WAS RESUMED, WITHOUT ANY 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 12443129 ↗
• MalfunctionSep 8, 2021Defective Component; Defective Component

  IT WAS REPORTED THAT, DURING WOUND TREATMENT, THE COBAN LAYER (4TH LAYER) OF A PROFORE MULTI-LAYER COMPRESSION LATEX FREE BANDAGING SYSTEM WAS HARD TO UNROLL. IT WAS POSSIBLE TO UNROLL ABOUT 3/4 OF THE BANDAGE, BUT THEN IT WAS EXTREMELY HARD TO IT PULL OFF. THIS CAUSED THE NURSE AND TECHS TO HURT THEIR SHOULDERS FOR PULLING SO HARD. TREATMENT WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, WITH A SMITH & NEPHEW BACK-UP DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: Pain

  MAUDE report 12440287 ↗
• MalfunctionSep 8, 2021Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT, DURING WOUND TREATMENT, THE 4TH LAYER OF COBAN OF A PROFORE MULTI-LAYER COMPRESSION LATEX FREE BANDAGING SYSTEM WAS OBSERVED TO BE ALMOST GLUED, FOR WHICH THE HOSPITAL'S STAFF ENDED UP CUTTING IT OFF AND FINISHING THE PATIENT'S LEG WITH AN ADDITIONAL ROLL OF COBAN. TREATMENT WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, WITH A SMITH & NEPHEW BACK-UP DEVICE. NO PATIENT INJURY REPORTED. OTHER SITES WITHIN THE SYSTEM ARE HAVING THE SAME COMPLAINT, FOR WHICH THE QUANTITY OF PATIENTS INVOLVED IS YET TO BE CONFIRMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12440129 ↗
• MalfunctionSep 8, 2021Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare

  IT WAS REPORTED THAT, DURING A TREATMENT SETUP, A PROFORE KIT LFF CASE 8 #4 COBAN LAYER WAS DIFFICULT TO UNROLL WITH ABOUT 1/4TH OF THE DRESSING LEFT. THEREFORE THERE WAS HIGH RISK OF INJURY TO THE PATIENT DUE TO THE POSSIBILITY OF APPLYING TOO MUCH COMPRESSION. THE DRESSING WAS CUT AND THEN ANOTHER COBAN LAYER WAS APPLIED TO FINISH THE PATIENT LEG. TREATMENT WAS COMPLETED WITH A BACKUP DEVICE, AFTER A NON-SIGNIFICANT DELAY. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12440030 ↗