DERMABOND PRINEO CLR222Recalls & reported problems

Summary

The FDA's MAUDE database contains 183 adverse event reports that list this exact device (DI 10705031237339), received between Dec 19, 2017 and Jan 23, 2026 — classified as 178 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (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 25 most recent of 183 reports, in the reporter's own words as published by the FDA.

• InjuryJan 23, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A KNEE REPLACEMENT ON (B)(6) 2025 AND TOPICAL SKIN ADHESIVE WAS USED. ON (B)(6) 2025, THE PATIENT DEVELOPED A SEVERE ALLERGIC REACTION TO THE TOPICAL SKIN ADHESIVE. THE REACTION WAS FULL BODY. STARTED AT WOUND SITE, SPREAD AROUND WHOLE BODY FROM THE RIGHT KNEE, UP THE LEG, ROUND TO PATIENT'S BOTTOM, AROUND THE HIPS, ACROSS THE BACK, ACROSS THE ABDOMEN, AND DOWN THE UN-OPERATED LEG AND DOWN THE CALF. LOOKED LIKE PATCHY REDNESS UNDER AND UPON SURFACE OF SKIN. ALSO SIGN OF FLAKINESS AROUND THE RASH CLOSEST TO THE WOUND SITE WHERE THE TOPICAL SKIN ADHESIVE WAS APPLIED. PATIENT WAS GIVEN ANTIBIOTICS, ANTIHISTAMINES AND REMOVED DRESSING. THE REACTION CLEARED UP FOLLOWING ANTIHISTAMINES AND ANTIBIOTICS. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Erythema; Hypersensitivity/Allergic reaction; Rash

  MAUDE report 24161614 ↗
• InjuryJan 23, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A HUMERUS FIXATION PROCEDURE ON (B)(6) 2025 AND TOPICAL SKIN ADHESIVE WAS USED. 7-10 DAYS AFTER SURGERY, THE PATIENT DEVELOPED A SEVERE ALLERGIC REACTION TO THE TOPICAL SKIN ADHESIVE. THE REACTION WAS FULL BODY. STARTED AT WOUND SITE, SPREAD AROUND WHOLE BODY FROM THE WOUND SITE AND ALL AROUND PATIENTS BODY, BACK, LEGS, GENITALS. LOOKED LIKE PATCHY REDNESS UNDER SURFACE OF SKIN. PATIENT WAS GIVEN ANTIBIOTICS, ANTIHISTAMINES AND REMOVED DRESSING. THE REACTION CLEARED UP FOLLOWING ANTIHISTAMINES AND ANTIBIOTICS. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Erythema; Hypersensitivity/Allergic reaction

  MAUDE report 24161612 ↗
• InjuryDec 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL KNEE REPLACEMENT ON AN UNKNOWN DATE AND TOPICAL SKIN ADHESIVE WAS USED. THE PATIENT EXPERIENCED A REACTION 2 DAYS POST OP. THE REACTION COVERS ONE TO TWO INCHES OUTSIDE THE BOARDER OF THE ADHESIVE. LOOKS LIKE CONTACT DERMATITIS. PRODUCT WAS REMOVED AND STEROID WAS PRESCRIBED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 23744683 ↗
• InjuryDec 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL KNEE REPLACEMENT OR TOTAL HIP PROCEDURE ON AN UNKNOWN DATE AND TOPICAL SKIN ADHESIVE WAS USED. THE PATIENT EXPERIENCED A REACTION 2 DAYS POST OP. THE REACTION COVERS ONE TO TWO INCHES OUTSIDE THE BOARDER OF THE ADHESIVE. LOOKS LIKE CONTACT DERMATITIS. PRODUCT WAS REMOVED AND STEROID WAS PRESCRIBED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 23744679 ↗
• 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 TOTAL KNEE ARTHROPLASTY ON (B)(6) 2025 AND TOPICAL SKIN ADHESIVE WAS USED. THE SURGEON OBSERVED AN ALLERGIC REACTION POST OPERATIVELY ON THE 3RD DAY. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 23381245 ↗
• InjuryMay 30, 2025Material Separation; Material Separation

  IT WAS REPORTED A PATIENT UNDERWENT A TOTAL KNEE ARTHROPLASTY ON AN UNKNOWN DATE IN 2025 AND TOPICAL SKIN ADHESIVE WAS USED. THE ADHESIVE HAS DETACHED DISTALLY FROM THE PATELLA ON THE TIBIA, CAUSE UNKNOWN. SURGEON REMOVED ADHESIVE COMPLETELY AND PUT STAPLERS ON TOP ON THE WARD. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Wound Dehiscence

  MAUDE report 22114518 ↗
• InjuryMar 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PATIENT UNDERWENT AN KNEE PROSTHESIS SURGERY ON (B)(6) 2025 AND TOPICAL SKIN ADHESIVE WAS USED. EVERYTHING WENT NORMAL. TODAY ALARM IS RAISED WITH THE INCISION AREA COMPLETELY INFECTED. TWO WEEKS AFTER THE SURGERY, INFECTION AND SECOND SURGERY TO CLOSE SKIN. SURGICAL CLEANING, SUTURING, INTRAVENOUS ANTIBIOTICS: CIPROFLOXACINE. SURGEON OPNINED: THE PATIENT HAS A CLOSED VARICOSE ULCER; SHE MAY HAVE SCRATCHED IT AND INTRODUCED BACTERIA INTO THE AREA. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Unspecified Infection

  MAUDE report 21646314 ↗
• InjuryMar 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PATIENT UNDERWENT A TOTAL KNEE ARTHROPLASTY ON AN UNKNOWN DATE IN 2024 AND TOPICAL SKIN ADHESIVE WAS USED. THE PATIENT HAD SKIN NOT HEALING, DERMATITIS, SKIN ABRASIONS, ALLERGIC REACTIONS, RASH, BLISTERS, SUPERFICIAL WOUND NECROSIS. PRODUCT REMOVAL, LOCAL WOUND CARE TOPICAL STEROIDS WERE NECESSARY, ORAL STEROIDS FOR SYSTEM REACTION. PATIENT STABLE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Abrasion; Blister; Hypersensitivity/Allergic reaction; Impaired Healing; Necrosis; Rash; Skin Inflammation/ Irritation

  MAUDE report 21624793 ↗
• InjuryMar 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PATIENT UNDERWENT A TOTAL KNEE ARTHROPLASTY ON AN UNKNOWN DATE AND TOPICAL SKIN ADHESIVE WAS USED. THE PATIENT HAD SKIN NOT HEALING, DERMATITIS, SKIN ABRASIONS, ALLERGIC REACTIONS, RASH, BLISTERS, SUPERFICIAL WOUND NECROSIS. PRODUCT REMOVAL, LOCAL WOUND CARE TOPICAL STEROIDS WERE NECESSARY, ORAL STEROIDS FOR SYSTEM REACTION. PATIENT STABLE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Abrasion; Blister; Hypersensitivity/Allergic reaction; Impaired Healing; Necrosis; Rash; Skin Inflammation/ Irritation

  MAUDE report 21624183 ↗
• InjuryMar 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PATIENT UNDERWENT A TOTAL KNEE ARTHROPLASTY ON AN UNKNOWN DATE IN 2024 AND TOPICAL SKIN ADHESIVE WAS USED. THE PATIENT HAD SKIN NOT HEALING, DERMATITIS, SKIN ABRASIONS, ALLERGIC REACTIONS, RASH, BLISTERS, SUPERFICIAL WOUND NECROSIS. PRODUCT REMOVAL, LOCAL WOUND CARE TOPICAL STEROIDS WERE NECESSARY, ORAL STEROIDS FOR SYSTEM REACTION. PATIENT STABLE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Abrasion; Blister; Hypersensitivity/Allergic reaction; Impaired Healing; Necrosis; Rash; Skin Inflammation/ Irritation

  MAUDE report 21623971 ↗
• InjuryMar 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PATIENT UNDERWENT A TOTAL KNEE ARTHROPLASTY ON AN UNKNOWN DATE IN 2024 AND TOPICAL SKIN ADHESIVE WAS USED. THE PATIENT HAD SKIN NOT HEALING, DERMATITIS, SKIN ABRASIONS, ALLERGIC REACTIONS, RASH, BLISTERS, SUPERFICIAL WOUND NECROSIS. PRODUCT REMOVAL, LOCAL WOUND CARE TOPICAL STEROIDS WERE NECESSARY, ORAL STEROIDS FOR SYSTEM REACTION. PATIENT STABLE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Abrasion; Blister; Hypersensitivity/Allergic reaction; Impaired Healing; Necrosis; Rash; Skin Inflammation/ Irritation

  MAUDE report 21623944 ↗
• InjuryMar 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PATIENT UNDERWENT A TOTAL KNEE ARTHROPLASTY ON AN UNKNOWN DATE IN 2024 AND TOPICAL SKIN ADHESIVE WAS USED. THE PATIENT HAD SKIN NOT HEALING, DERMATITIS, SKIN ABRASIONS, ALLERGIC REACTIONS, RASH, BLISTERS, SUPERFICIAL WOUND NECROSIS. PRODUCT REMOVAL, LOCAL WOUND CARE TOPICAL STEROIDS WERE NECESSARY, ORAL STEROIDS FOR SYSTEM REACTION. PATIENT STABLE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Abrasion; Blister; Hypersensitivity/Allergic reaction; Impaired Healing; Necrosis; Rash; Skin Inflammation/ Irritation

  MAUDE report 21623934 ↗
• InjuryMar 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PATIENT UNDERWENT A TOTAL KNEE ARTHROPLASTY ON AN UNKNOWN DATE IN 2024 AND TOPICAL SKIN ADHESIVE WAS USED. THE PATIENT HAD SKIN NOT HEALING, DERMATITIS, SKIN ABRASIONS, ALLERGIC REACTIONS, RASH, BLISTERS, SUPERFICIAL WOUND NECROSIS. PRODUCT REMOVAL, LOCAL WOUND CARE TOPICAL STEROIDS WERE NECESSARY, ORAL STEROIDS FOR SYSTEM REACTION. PATIENT STABLE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Abrasion; Blister; Hypersensitivity/Allergic reaction; Impaired Healing; Necrosis; Rash; Skin Inflammation/ Irritation

  MAUDE report 21623909 ↗
• InjuryMar 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PATIENT UNDERWENT A TOTAL KNEE ARTHROPLASTY ON AN UNKNOWN DATE IN 2024 AND TOPICAL SKIN ADHESIVE WAS USED. THE PATIENT HAD SKIN NOT HEALING, DERMATITIS, SKIN ABRASIONS, ALLERGIC REACTIONS, RASH, BLISTERS, SUPERFICIAL WOUND NECROSIS. PRODUCT REMOVAL, LOCAL WOUND CARE TOPICAL STEROIDS WERE NECESSARY, ORAL STEROIDS FOR SYSTEM REACTION. PATIENT STABLE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Abrasion; Blister; Hypersensitivity/Allergic reaction; Impaired Healing; Necrosis; Rash; Skin Inflammation/ Irritation

  MAUDE report 21623899 ↗
• InjuryMar 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PATIENT UNDERWENT A TOTAL KNEE ARTHROPLASTY ON AN UNKNOWN DATE IN 2024 AND TOPICAL SKIN ADHESIVE WAS USED. THE PATIENT HAD SKIN NOT HEALING, DERMATITIS, SKIN ABRASIONS, ALLERGIC REACTIONS, RASH, BLISTERS, SUPERFICIAL WOUND NECROSIS. PRODUCT REMOVAL, LOCAL WOUND CARE TOPICAL STEROIDS WERE NECESSARY, ORAL STEROIDS FOR SYSTEM REACTION. PATIENT STABLE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Abrasion; Blister; Hypersensitivity/Allergic reaction; Impaired Healing; Necrosis; Rash; Skin Inflammation/ Irritation

  MAUDE report 21623869 ↗
• InjuryMar 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PATIENT UNDERWENT A TOTAL KNEE ARTHROPLASTY ON AN UNKNOWN DATE IN 2024 AND TOPICAL SKIN ADHESIVE WAS USED. THE PATIENT HAD SKIN NOT HEALING, DERMATITIS, SKIN ABRASIONS, ALLERGIC REACTIONS, RASH, BLISTERS, SUPERFICIAL WOUND NECROSIS. PRODUCT REMOVAL, LOCAL WOUND CARE TOPICAL STEROIDS WERE NECESSARY, ORAL STEROIDS FOR SYSTEM REACTION. PATIENT STABLE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Abrasion; Blister; Hypersensitivity/Allergic reaction; Impaired Healing; Necrosis; Rash; Skin Inflammation/ Irritation

  MAUDE report 21623753 ↗
• InjuryMar 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PATIENT UNDERWENT A TOTAL KNEE ARTHROPLASTY ON AN UNKNOWN DATE IN 2024 AND TOPICAL SKIN ADHESIVE WAS USED. THE PATIENT HAD SKIN NOT HEALING, DERMATITIS, SKIN ABRASIONS, ALLERGIC REACTIONS, RASH, BLISTERS, SUPERFICIAL WOUND NECROSIS. PRODUCT REMOVAL, LOCAL WOUND CARE TOPICAL STEROIDS WERE NECESSARY, ORAL STEROIDS FOR SYSTEM REACTION. PATIENT STABLE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Abrasion; Blister; Hypersensitivity/Allergic reaction; Impaired Healing; Necrosis; Rash; Skin Inflammation/ Irritation

  MAUDE report 21623724 ↗
• InjuryMar 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PATIENT UNDERWENT A HIP ARTHROPLASTY PROCEDURE ON (B)(6) 2025 AND TOPICAL SKIN ADHESIVE WAS USED. 2 WEEKS POST OP, PATIENT HAD ISSUE THAT SEEMS TO BE LIKE AN ALLERGIC REACTION, WITH RED IRRITATION. THE SURGEON PRESCRIBED MEDICINES FOR 4 DAYS ( XOZAL AND CORTISONE OINTMENT). ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Erythema; Hypersensitivity/Allergic reaction

  MAUDE report 21599067 ↗
• InjuryJan 31, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PATIENT UNDERWENT A KNEE SURGERY ON (B)(6) 2024 AND TOPICAL SKIN ADHESIVE WAS USED. PATIENT HAD DEVELOPED SKIN BOILS/BLISTERS (SEROMA)ON THE SKIN AROUND THE MESH OF ADHESIVE. TREATED WITH ANTIBIOTICS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blister; Hemorrhage/Blood Loss/Bleeding; Seroma

  MAUDE report 21286994 ↗
• InjuryJan 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PATIENT UNDERWENT AN ORTHOPEDIC PROCEDURE, IMPLANTS REMOVAL FROM THE FOREARM, ON AN UNKNOWN DATE IN 2024 AND TOPICAL SKIN ADHESIVE WAS USED. PROCEDURE TO REMOVE THE IMPLANTS AND THERE WAS A DERMA REACTION, INFLAMMATION, THAT THE HAD TO HANDLE WITH PRESCRIPTION OF ANTIBIOTICS AND TOPICAL CREAM, DERMATOLOGY VISIT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Inflammation; Skin Inflammation/ Irritation

  MAUDE report 21078329 ↗
• InjuryDec 31, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PATIENT HAD A HIP PROCEDURE ON AN UNKNOWN DATE IN 2024 AND TOPICAL SKIN ADHESIVE WAS USED. POST-SURGERY WOUND HEALING DISORDER. WOUND CONTROL HAD DECIDED TO GRANULATE THE WOUND. MORE DETAILS NEED TO BE FURTHER INVESTIGATED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Impaired Healing; Wound Dehiscence

  MAUDE report 21048104 ↗
• InjuryDec 27, 2024Material Separation; Material Separation

  IT WAS REPORTED A PATIENT UNDERWENT A KNEE ARTHROSCOPY ON (B)(6) 2024 AND TOPICAL SKIN ADHESIVE WAS USED. THE ADHESIVE MESH PEELED OFF 70% AND PRODUCED BLOOD FLECTINS IN KNEE. HIS ADMISSION WAS EXTENDED BY A WEEK. THE PATIENT HAD A REACTION TO FLECTINA SHEMATICAS, AND ON THE SECOND DAY 70% OF THE PRODUCT CAME OFF AND STERISTRIP WAS PLACED AND HE REMAINED AT REST FOR 10 DAYS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information; Skin Inflammation/ Irritation

  MAUDE report 21026109 ↗
• InjuryDec 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PATIENT UNDERWENT A HIP SURGERY ON (B)(6) 2024 AND TOPICAL SKIN ADHESIVE WAS USED. PATIENT HAD A SEVERE SKIN REACTION WITH ADHESIVE. PRODUCT WAS REMOVED AND GIVEN ORAL ANTIBIOTICS AND STEROIDS. ISSUE IS RESOLVING. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 20864646 ↗
• InjuryDec 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PATIENT UNDERWENT A KNEE JOINT REPLACEMENT SURGERY ON (B)(6) 2024 AND TOPICAL SKIN ADHESIVE WAS USED. IT SHOULD BE NOTED THAT DURING THE SURGERY, THE SURGEON CHANGED THE MANNER OF CLOSING THE DEEP LAYERS OF THE SURGICAL INCISION IN A WAY THAT HE USED FEWER STITCHES. AFTER SEVERAL DAYS, THE PATIENT VISITED THE SURGEON¿S CLINIC, CLAIMING THAT THE SURGICAL WOUND APPEARED ABNORMAL AND THAT HE FELT DISCOMFORT. THE SURGEON NOTED THAT HE OBSERVED EXCESSIVE FLUIDS AROUND THE INCISION AREA, AND THAT THE ADHESIVE CONTINUED TO COMPLETELY SEAL THE WOUND. THE SURGEON REMOVED THE ADHESIVE, DRAINED THE FLUIDS, AND CLEANED THE SKIN. THE SURGEON NOTED THAT THE PATIENT WAS IN GOOD CONDITION. THE SURGEON RAISED THE SUPPOSITION THAT THE ISSUE OF FLUID ACCUMULATION/FORMATION IN THE AREA OF THE SURGICAL INCISION MIGHT BE RELATED TO THE CHANGE HE MADE IN THE MANNER OF CLOSING THE DEEP LAYERS OF THE SURGICAL INCISION. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Fluid Discharge

  MAUDE report 20863492 ↗
• InjuryOct 24, 2024Adverse 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 AN TOPICAL SKIN ADHESIVE WAS USED. PATIENT IS HAVING POST OP ALLERGIC REACTION AFTER USING ADHESIVE WITH INFECTION AND INFLAMMATION. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Hypersensitivity/Allergic reaction; Inflammation; Unspecified Infection

  MAUDE report 20523503 ↗