DERMABOND PRINEO CLR222USRecalls & reported problems

Summary

The FDA's MAUDE database contains 790 adverse event reports that list this exact device (DI 10705031230996), received between Nov 29, 2017 and Sep 29, 2026 — classified as 689 injuries, 101 malfunctions.

The most frequently reported specific device problem is “Device Markings/Labelling Problem” (62 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 790 reports, in the reporter's own words as published by the FDA.

• InjurySep 29, 2026Material Separation; Adverse Event Without Identified Device or Use Problem

  Patient problems: Necrosis

  MAUDE report 50938660 ↗
• InjurySep 29, 2026Material Separation; Adverse Event Without Identified Device or Use Problem

  Patient problems: Necrosis

  MAUDE report 50938647 ↗
• InjurySep 10, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that a patient underwent a hardware removal knee procedure on an unknown date and a topical skin adhesive was used. It was reported by the Orthopedic PA that a patient having a tension blister 10 days ago when utilizing the topical skin adhesive. The adhesive was removed in the office and prescription strength Benadryl was given. Additional information was requested.

  Patient problems: Blister

  MAUDE report 50717410 ↗
• InjuryAug 21, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that a patient underwent an unknown procedure on an unknown date and suture was used. The patient experienced delayed wound healing. They may have had to reoperate to revise the incision. Additional information was requested.

  Patient problems: Impaired Healing

  MAUDE report 50369731 ↗
• InjuryAug 21, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that a patient underwent an unknown procedure on an unknown date and suture was used. The patient experienced delayed wound healing. They may have had to reoperate to revise the incision. Additional information was requested.

  Patient problems: Impaired Healing

  MAUDE report 50369705 ↗
• InjuryJul 29, 2026Adverse Event Without Identified Device or Use Problem

  It was reported a patient underwent an unknown procedure on an unknown date in (b)(6) 2026 and topical skin adhesive was used. A reaction occurred. He said this was on a middle-aged woman with no known adhesive allergies. They used the proper screening prior, and the adhesive was applied properly. Reaction started under the adhesive then later spread and blistered around the mesh. Oral steroid was taken and cleared up the reaction. No image to provide. The device was not returning. Additional information has been requested.

  Patient problems: Blister; Skin Inflammation/ Irritation

  MAUDE report 50069510 ↗
• InjuryJun 3, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PATIENT UNDERWENT A RIGHT ROBOTICALLY ASSISTED TOTAL KNEE ARTHROPLASTY ON (B)(6) 2025 AND TOPICAL SKIN ADHESIVE WAS USED. PATIENT HAD AN ADVERSE REACTION TO ADHESIVE. SHE WAS GIVEN A SCRIPT FOR ANTIHISTAMINES AND PAIN RELIEF. SHE WENT HOME WITH MEPITEL AND LEUKOMED SORBACT DRESSINGS AS THIS IS THE USUAL TREATMENT FOR REACTION. SHE HAD OOZE ALMOST BREACHING THROUGH THE DRESSING WE CHANGED HER DRESSING TO MEPITEL AND SORBION SORBACT. PATIENT WAS GIVEN PREDNISONE AT THIS POINT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Erythema; Fluid Discharge; Skin Inflammation/ Irritation

  MAUDE report 25374994 ↗
• MalfunctionMay 29, 2026Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED UPON OPENING TOPICAL SKIN ADHESIVE ON AN UNKNOWN DATE IN 2026. A YELLOW STAIN FOUND ON PRODUCTS. ITEM WERE NOT USED ON PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25337456 ↗
• MalfunctionMay 29, 2026Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED UPON OPENING TOPICAL SKIN ADHESIVE ON AN UNKNOWN DATE IN 2026. A YELLOW STAIN FOUND ON PRODUCTS. ITEM WERE NOT USED ON PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25337453 ↗
• MalfunctionMay 29, 2026Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED UPON OPENING TOPICAL SKIN ADHESIVE ON AN UNKNOWN DATE IN 2026. A YELLOW STAIN FOUND ON PRODUCTS. ITEM WERE NOT USED ON PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25337450 ↗
• MalfunctionMay 29, 2026Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED UPON OPENING TOPICAL SKIN ADHESIVE ON AN UNKNOWN DATE IN 2026. A YELLOW STAIN FOUND ON PRODUCTS. ITEM WERE NOT USED ON PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25337448 ↗
• MalfunctionMay 29, 2026Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED UPON OPENING TOPICAL SKIN ADHESIVE ON AN UNKNOWN DATE IN 2026.A YELLOW STAIN FOUND ON PRODUCTS. ITEM WERE NOT USED ON PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25337446 ↗
• MalfunctionMay 29, 2026Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED UPON OPENING TOPICAL SKIN ADHESIVE ON AN UNKNOWN DATE IN 2026. A YELLOW STAIN FOUND ON PRODUCTS. ITEM WERE NOT USED ON PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25337443 ↗
• InjuryMay 15, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND A TOPICAL SKIN ADHESIVE WAS USED. POST-OPERATIVELY, THE PATIENT EXPERIENCED BLISTERING AND RASH. THE SURGEON EVALUATED THE CONDITION AND PRESCRIBED TOPICAL CREAMS FOR MANAGEMENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Blister; Rash

  MAUDE report 25185181 ↗
• InjuryMay 15, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND A TOPICAL SKIN ADHESIVE WAS USED. POST-OPERATIVELY, THE PATIENT EXPERIENCED BLISTERING AND RASH. THE SURGEON EVALUATED THE CONDITION AND PRESCRIBED TOPICAL CREAMS FOR MANAGEMENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Blister; Rash

  MAUDE report 25185180 ↗
• InjuryMay 15, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND A TOPICAL SKIN ADHESIVE WAS USED. POST-OPERATIVELY, THE PATIENT EXPERIENCED BLISTERING AND RASH. THE SURGEON EVALUATED THE CONDITION AND PRESCRIBED TOPICAL CREAMS FOR MANAGEMENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Blister; Rash

  MAUDE report 25185178 ↗
• InjuryMay 6, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PATIENT UNDERWENT AN INTERNAL FIXATOR REMOVAL ON (B)(6) 2026 AND TOPICAL SKIN ADHESIVE WAS USED. NO ABNORMALITIES DURING HOSPITALIZATION. DURING THE FOLLOW-UP VISIT ON (B)(6) 2026, THE DOCTOR FOUND THAT THE AREA AROUND THE WOUND WAS RED AND SWOLLEN AND THERE WERE SMALL BLISTERS. THE DOCTOR HAS REMOVED THE ADHESIVE AND TREATED IT ACCORDING TO THE ALLERGY SOP, ALLOWING THE PATIENT TO TAKE MEDICINE AND RECEIVE ANTI-ALLERGY INJECTIONS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blister; Erythema; Swelling/ Edema

  MAUDE report 25099876 ↗
• InjuryApr 29, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PATIENT UNDERWENT ON UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND TOPICAL SKIN ADHESIVE WAS USED. PATIENT IS FACING SEVERE DERMATITIS, BLISTERING, INFECTION. PATIENT HAS BEEN DISCHARGE TO DERMATOLOGIST FOR SKIN REACTION TREATMENT. PRESCRIBED TOPICAL ANTIBIOTICS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blister; Erythema; Rash; Skin Inflammation/ Irritation; Unspecified Infection

  MAUDE report 25029029 ↗
• InjuryApr 29, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PATIENT UNDERWENT ON UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND TOPICAL SKIN ADHESIVE WAS USED. PATIENT IS FACING SEVERE DERMATITIS, BLISTERING, INFECTION. PATIENT HAS BEEN DISCHARGE TO DERMATOLOGIST FOR SKIN REACTION TREATMENT. PRESCRIBED TOPICAL ANTIBIOTICS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blister; Erythema; Rash; Skin Inflammation/ Irritation; Unspecified Infection

  MAUDE report 25028856 ↗
• InjuryApr 28, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PATIENT UNDERWENT ON UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND TOPICAL SKIN ADHESIVE WAS USED. PATIENT IS FACING SEVERE DERMATITIS, BLISTERING, INFECTION. PATIENT HAS BEEN DISCHARGE TO DERMATOLOGIST FOR SKIN REACTION TREATMENT. PRESCRIBED TOPICAL ANTIBIOTICS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blister; Erythema; Rash; Skin Inflammation/ Irritation; Unspecified Infection

  MAUDE report 25022078 ↗
• InjuryApr 28, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PATIENT UNDERWENT ON UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND TOPICAL SKIN ADHESIVE WAS USED. PATIENT IS FACING SEVERE DERMATITIS, BLISTERING, INFECTION. PATIENT HAS BEEN DISCHARGE TO DERMATOLOGIST FOR SKIN REACTION TREATMENT. PRESCRIBED TOPICAL ANTIBIOTICS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blister; Erythema; Rash; Skin Inflammation/ Irritation; Unspecified Infection

  MAUDE report 25022008 ↗
• InjuryApr 28, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PATIENT UNDERWENT ON UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND TOPICAL SKIN ADHESIVE WAS USED. PATIENT IS FACING SEVERE DERMATITIS, BLISTERING, INFECTION. PATIENT HAS BEEN DISCHARGE TO DERMATOLOGIST FOR SKIN REACTION TREATMENT. PRESCRIBED TOPICAL ANTIBIOTICS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blister; Erythema; Rash; Skin Inflammation/ Irritation; Unspecified Infection

  MAUDE report 25021929 ↗
• InjuryApr 28, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PATIENT UNDERWENT ON UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND TOPICAL SKIN ADHESIVE WAS USED. PATIENT IS FACING SEVERE DERMATITIS, BLISTERING, INFECTION. PATIENT HAS BEEN DISCHARGE TO DERMATOLOGIST FOR SKIN REACTION TREATMENT. PRESCRIBED TOPICAL ANTIBIOTICS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blister; Erythema; Rash; Skin Inflammation/ Irritation; Unspecified Infection

  MAUDE report 25021853 ↗
• InjuryApr 28, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PATIENT UNDERWENT ON UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND TOPICAL SKIN ADHESIVE WAS USED. PATIENT IS FACING SEVERE DERMATITIS, BLISTERING, INFECTION. PATIENT HAS BEEN DISCHARGE TO DERMATOLOGIST FOR SKIN REACTION TREATMENT. PRESCRIBED TOPICAL ANTIBIOTICS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blister; Erythema; Rash; Skin Inflammation/ Irritation; Unspecified Infection

  MAUDE report 25021694 ↗
• InjuryApr 28, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PATIENT UNDERWENT ON UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND TOPICAL SKIN ADHESIVE WAS USED. PATIENT IS FACING SEVERE DERMATITIS, BLISTERING, INFECTION. PATIENT HAS BEEN DISCHARGE TO DERMATOLOGIST FOR SKIN REACTION TREATMENT. PRESCRIBED TOPICAL ANTIBIOTICS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blister; Erythema; Rash; Skin Inflammation/ Irritation; Unspecified Infection

  MAUDE report 25021666 ↗