DERMABOND PRINEO CLR422USRecalls & reported problems

Summary

The FDA's MAUDE database contains 46 adverse event reports that list this exact device (DI 10705031240421), received between Oct 22, 2018 and Jun 12, 2026 — classified as 44 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Delivered as Unsterile Product” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 46 reports, in the reporter's own words as published by the FDA.

• InjuryJun 12, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND TOPICAL SKIN ADHESIVE WAS USED. THE CUSTOMER REPORTED A SEVERE SKIN REACTION TO THE APPLICATION OF ADHESIVE. PRESCRIBED ANTIHISTAMINES. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 25488138 ↗
• MalfunctionJun 8, 2026Device Contaminated During Manufacture or Shipping; Material Integrity Problem

  IT WAS REPORTED UPON OPENING ON 4-MAR-2026 THE TOPICAL SKIN ADHESIVE HAD AN ISSUE. OPENED BOX AND OBSERVED THAT UNIT WAS LEAKING THROUGH THE PACKAGING. ONE OF THE PACKETS APPEAR TO BE GROWING SOMETHING INSIDE THE GLUE TUBE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25427761 ↗
• InjuryMay 19, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PATIENT UNDERWENT A TOTAL KNEE ARTHROPLASTY PROCEDURE ON AN UNKNOWN DATE IN (B)(6) 2026 AND TOPICAL SKIN ADHESIVE WAS USED. A PATIENT EXPERIENCED A SIGNIFICANT SKIN REACTION WITH ADHESIVE. REACTION EXTENDED DOWN TIBIA TO MID THIGH. TENDER, CRUSTING, RED, HOT SKIN. PRESCRIPTION ANTIHISTAMINES AND TOPICAL STEROID CREAM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blister; Burning Sensation; Skin Inflammation/ Irritation

  MAUDE report 25221226 ↗
• InjuryMay 19, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN JOINT REPLACEMENT PROCEDURE ON AN UNKNOWN DATE AND TOPICAL SKIN ADHESIVE WAS USED. PATIENT SKIN REACTION AT 2 WEEK POST OP FOLLOW UP AS SIGNIFICANT- RED, INFLAMED WHOLE LEG/THIGH AND UPPER BACK AREA. SEROUS OOZING AND WET UNDER DRESSING. PRESCRIPTION STRENGTH MEDICATION BENADRYL AND TOPICAL STEROID AND PRODUCT REMOVAL. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

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

  MAUDE report 25220182 ↗
• InjuryMay 19, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN JOINT REPLACEMENT PROCEDURE ON AN UNKNOWN DATE AND TOPICAL SKIN ADHESIVE WAS USED. PATIENT SKIN REACTION /CONTACT DERMATITIS WITH ADHESIVE. PRESCRIPTIONS FOR BENEDRYL STEROIDS CREAM, ADDITIONAL INFORMATION HAS BEEN REQUESTED.

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

  MAUDE report 25220024 ↗
• 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 25028928 ↗
• InjuryApr 29, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN KNEE 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 25028765 ↗
• InjuryApr 28, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PATIENT UNDERWENT AN 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 25021326 ↗
• InjuryApr 28, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PATIENT UNDERWENT ON UNKNOWN KNEE 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 25021167 ↗
• InjuryApr 14, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PATIENT UNDERWENT AN CABG PROCEDURE ON AN UNKNOWN DATE IN 2026 AND TOPICAL SKIN ADHESIVE WAS USED. SKIN REACTION REPORTED DUE TO USE OF LEG INCISION. . THIS PATIENT WAS CAGS. PATIENT DID HAVE A BELOVAC DRAIN PLACED IN THE LEG SURGEON REMEMBER PATIENT WAS VERY OEDEMATOUS AND THE REG AT THE TIME SAID SHE HAD WRAPPED THE LEG WITH CREPE RATHER TIGHTLY- SURGEON ATTRIBUTED THE WOUND BREAK DOWN TO THE SHEARING FROM THAT AND EXCESS FLUID. REQUIRED VAC AND WASHOUTS. SKIN WOUND DEBRIDEMENT FOR PATIENT AFTER ADHESIVE REMOVED ALL SKIN UPON REMOVAL OF BLISTERING REACTION. PATIENT REPORTEDLY HAD PLASTIC SURGEON INVOLVEMENT AND DEBRIDEMENT OF WOUND AFTER ADHESIVE REMOVAL PEELED ALL SKIN OFF. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blister; Skin Inflammation/ Irritation; Wound Dehiscence

  MAUDE report 24876679 ↗
• InjuryApr 9, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN SPINE SURGERY ON AN UNKNOWN DATE IN 2026 A TOPICAL SKIN ADHESIVE WAS USED. PATIENT RETURNING WITH SKIN REACTION. PA APPLYING WAS THE SAME. ANTIBIOTICS WERE GIVEN. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 24828088 ↗
• InjuryApr 9, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN SPINE SURGERY ON AN UNKNOWN DATE IN 2026 A TOPICAL SKIN ADHESIVE WAS USED. PATIENT RETURNING WITH SKIN REACTION. PA APPLYING WAS THE SAME.. ANTIBIOTICS WERE GIVEN. ADDITIONAL INFORMATION HAS BEEN REQUETED.

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 24828084 ↗
• InjuryMar 18, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PATIENT UNDERWENT AN TOTAL KNEE PROCEDURE ON AN UNKNOWN DATE IN (B)(6) 2026 A TOPICAL SKIN ADHESIVE WAS USED. THE PATIENT HAD BAD REACTION TO THE SKIN GLUE. PATIENT HAD TO COME BACK TO PUT INTO MEDICATION. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 24627625 ↗
• InjuryMar 18, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PATIENT UNDERWENT AN TOTAL KNEE PROCEDURE ON AN UNKNOWN DATE IN 2026 AND TOPICAL SKIN ADHESIVE WAS USED. THE PATIENT HAD BAD REACTION TO THE SKIN GLUE. PATIENT HAD TO COME BACK TO PUT INTO MEDICATION. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 24627624 ↗
• InjuryMar 3, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN ORTHOPEDIC PROCEDURE ON AN UNKNOWN DATE AND TOPICAL SKIN ADHESIVE WAS USED. PATIENT PRESENTED WITH RASHES AS SPREADING ERYTHEMATOUS, PERIODIC, AND MINIMALLY RAISED LESIONS. GIVEN A STEROID CREAM AND SAY THAT THE REACTION IS CUMBERSOME. GIVEN A MEDROL STEROID PACK AND HAVE A MORE UNCOMFORTABLE EXPERIENCE WITH THE REACTION. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

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

  MAUDE report 24502544 ↗
• InjuryMar 3, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN ORTHOPEDIC PROCEDURE ON AN UNKNOWN DATE AND TOPICAL SKIN ADHESIVE WAS USED. PATIENT PRESENTED WITH RASHES AS SPREADING ERYTHEMATOUS, PERIODIC, AND MINIMALLY RAISED LESIONS. GIVEN A STEROID CREAM AND SAY THAT THE REACTION IS CUMBERSOME. GIVEN A MEDROL STEROID PACK AND HAVE A MORE UNCOMFORTABLE EXPERIENCE WITH THE REACTION. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

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

  MAUDE report 24502533 ↗
• InjuryFeb 24, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN OB-GYN SURGERY ON AN UNKNOWN DATE AND TOPICAL SKIN ADHESIVE WAS USED. IN THE WARDS/ICU, ADHESIVE WAS APPLIED AFTER SURGERY. AFTER REMOVING IT AND USING MEDICATION, THE CONDITION RETURNED TO NORMAL. THE PRODUCT WAS USED ON THE EPIDERMIS. NO SAMPLE WILL BE RETURNED. FURTHER DETAILS ARE NOT PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Skin Discoloration; Skin Inflammation/ Irritation

  MAUDE report 24433774 ↗
• InjuryNov 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A RIGHT TOTAL KNEE REVISION ON (B)(6) 2025 AND TOPICAL SKIN ADHESIVE WAS USED. THE PATIENT EXPERIENCED A BURNING LOOKING REACTION, DEEP PURPLE, SKIN RAW, SWOLLEN WITH INFLAMMATION, REDNESS AND BLISTERING. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Blister; Burn(s); Inflammation; Insufficient Information; Skin Inflammation/ Irritation; Swelling/ Edema

  MAUDE report 23543667 ↗
• InjuryOct 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A SPINAL FUSION ON (B)(6) 2025 AND TOPICAL SKIN ADHESIVE WAS USED ON THE WOUNDS AND ALSO USED BETWEEN THE WOUNDS. THE PATIENT DEVELOPED A FEVER (38.7°C) FROM THE 11TH DAY, AND TISSUE NECROSIS WAS OBSERVED WHEN THE TOPICAL SKIN ADHESIVE WAS REMOVED TWO WEEKS AFTER SURGERY. DEBRIDEMENT WAS PERFORMED, AND THE PATIENT IS STILL HOSPITALIZED. IT WAS CONFIRMED THAT THERE WERE EIGHT WOUNDS IN TOTAL, INCLUDING A LARGE WOUND IN THE MIDDLE OF THE INTERBODY FUSION AND FOUR SMALL WOUNDS FROM SIDE TO SIDE. THE WOUNDS WERE NOT NECROTIC BUT RATHER THE AREA BETWEEN THE MIDDLE INCISION AND THE SMALL INCISION ON THE RIGHT SIDE HAD TURNED COMPLETELY BLACK AND WAS NECROTIC. ADDITIONAL SUTURE WAS PERFORMED TO COMPLETE THE CASE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Fever; Necrosis

  MAUDE report 23383644 ↗
• InjuryAug 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PATIENT UNDERWENT PROCEDURE ON (B)(6) 2025 AND TOPICAL SKIN ADHESIVE WAS USED. PATIENT HAD REACTION TO ADHESIVE, THERE WERE RASHES OVER THE ENTIRE BODY: CHEST, HANDS, BACK. TOPICAL STEROIDS USED ON THE RASHES AND MEDROL PAK. DEVICE AVAILABILITY UNKNOWN. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Hypersensitivity/Allergic reaction; Rash

  MAUDE report 22818137 ↗
• InjuryAug 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PATIENT UNDERWENT PROCEDURE ON (B)(6) 2025 AND TOPICAL SKIN ADHESIVE WAS USED. PATIENT HAD REACTION TO ADHESIVE, THERE WERE RASHES OVER THE ENTIRE BODY: CHEST, HANDS, BACK. TOPICAL STEROIDS USED ON THE RASHES AND MEDROL PAK. DEVICE AVAILABILITY UNKNOWN. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Hypersensitivity/Allergic reaction; Rash

  MAUDE report 22818089 ↗
• InjuryAug 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PATIENT UNDERWENT PROCEDURE ON (B)(6) 2025 AND TOPICAL SKIN ADHESIVE WAS USED. PATIENT HAD REACTION TO ADHESIVE, THERE WERE RASHES OVER THE ENTIRE BODY: CHEST, HANDS, BACK. TOPICAL STEROIDS USED ON THE RASHES AND MEDROL PAK. DEVICE AVAILABILITY UNKNOWN. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Hypersensitivity/Allergic reaction; Rash

  MAUDE report 22818063 ↗
• InjuryJun 27, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE IN 2025 AND TOPICAL SKIN ADHESIVE WAS USED. PATIENT IS UNABLE TO REMOVE THE ADHESIVE PRODUCT, EVEN WITH JELLIES. WHEN IT FINALLY COMES OFF, IT TAKES SKIN AND REOPENS WOUNDS. DEVICE IS NOT AVAILABLE FOR RETURN. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Skin Erosion; Unspecified Tissue Injury; Wound Dehiscence

  MAUDE report 22346486 ↗
• InjuryJun 27, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE IN 2025 AND TOPICAL SKIN ADHESIVE WAS USED. PATIENT IS UNABLE TO REMOVE THE ADHESIVE PRODUCT, EVEN WITH JELLIES. WHEN IT FINALLY COMES OFF, IT TAKES SKIN AND REOPENS WOUNDS. DEVICE IS NOT AVAILABLE FOR RETURN. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Skin Erosion; Unspecified Tissue Injury; Wound Dehiscence

  MAUDE report 22346484 ↗
• InjuryJun 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PATIENT UNDERWENT A CARDIAC PROCEDURE ON AN UNKNOWN DATE IN 2025 AND TOPICAL SKIN ADHESIVE WAS USED. POST OP, PATIENT HAD SKIN REACTION TO THE ADHESIVE. THE PATIENT WAS TREATED WITH HYDROCORTISONE, OPEN AIR, AND THEY WERE PUT ON A STEROID CREAM. NO DEVICE WILL BE RETURNED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Erythema; Skin Inflammation/ Irritation

  MAUDE report 22152961 ↗