DERMABOND PRINEO CLR602USRecalls & reported problems

Summary

The FDA's MAUDE database contains 80 adverse event reports that list this exact device (DI 10705031024168), received between Apr 20, 2018 and Sep 10, 2026 — classified as 70 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (8 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 80 reports, in the reporter's own words as published by the FDA.

• InjurySep 10, 2026Adverse Event Without Identified Device or Use Problem

  Title: Formaldehyde Emissions From 2-Octyl Cyanoacrylate: Quantified Risk for Allergic Contact Dermatitis. The aim of this study is to quantify the amount of formaldehyde emitted from 2-octyl cyanoacrylate (OCA) adhesives and to assess the risk that these formaldehyde emissions could contribute to allergic contact dermatitis (ACD) in exposed patients. Dermabond Prineo (ETH) was used for skin closure of surgical incisions after surgery.Reported Complications:Demabond Prineo (ETH)Allergic Contact Dermatitis (ACD) (n=?)Treatment: not reportedErythema (n=?)Treatment: not reportedEdema (n=?)Treatment: not reportedVesicles/blister formation (n=?)Treatment: not reportedSystemic erythema (n=?)Treatment: not reportedIncreased risk of surgical site infection (SSI) secondary to hypersensitivity reactions (n=?)Treatment: not reportedIn conclusion, 2-octyl-cyanoacrylate-mesh-systems emit formaldehyde at levels exceeding sensitization and inhalation thresholds, raising concern for dermal and respiratory exposure, particularly in sensitised individuals. Prior sensitisation from adhesives such as nail, eyelash or super glues may heighten risk.

  Patient problems: Blister; Erythema; Hypersensitivity/Allergic reaction; Local Reaction; Swelling/ Edema; Unspecified Infection

  MAUDE report 50717466 ↗
• InjurySep 1, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that a patient underwent an unknown procedure and topical skin adhesive was used. The patient has already used the product in previous surgery without any reaction, indicating unprecedented sensitivity at this time. Chronology: (b)(6) 2026: Surgery with application of the product in the incision. (b)(6) 2026: Early erythema and severe itching on site. No improvement with oral antiallergic. (b)(6) 2026: Reaction became systemic by the body. Emergency care with intravenous and intramuscular medication. Severe allergic rebound occurred after 8h, requiring new emergency care. Current situation: Local injury (burning aspect). The surgeon removed the glue mechanically. Due to the severity of the skin, it was necessary to follow up with a dermatologist. The patient follows treatment to contain the allergy being accompanied by surgeon and dermatologist. No additional information was provided.

  Patient problems: Burn(s); Erythema; Hypersensitivity/Allergic reaction; Itching Sensation

  MAUDE report 50549722 ↗
• InjuryApr 30, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PATIENT UNDERWENT A PLASTIC SURGERY MASTOPEXY ON AN UNKNOWN DATE IN 2026 A TOPICAL SKIN ADHESIVE WAS USED. IN PATIENT OF 4 DAYS AFTER APPLYING THE PRODUCT, THE PATIENT PRESENTED ALLERGY WITH SYMPTOMS OF ERYTHEMA AND PRURITUS. THE SURGEON PROCEEDED TO WITHDRAW THE PRODUCT AND PRESCRIBE ANTIHISTAMINE AND TOPICAL CORTICOSTEROID. PATIENT IS IN FOLLOW-UP; HE HAS HYPERPIGMENTATION OF THE SCAR AND AROUND IT (THE ENTIRE AREA OF APPLICATION OF THE PRODUCT). ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Erythema; Hypersensitivity/Allergic reaction; Itching Sensation; Skin Discoloration

  MAUDE report 25046904 ↗
• InjuryApr 15, 2026Adverse Event Without Identified Device or Use Problem

  THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: COMPARATIVE STUDY OF 2-OCTYLCYANOACRYLATE PLUS POLYMER MESH TAPE AND SURGICAL STAPLER FOR PREVENTING SURGICAL SITE INFECTION FOLLOWING CORRECTIVE FUSION IN PATIENTS WITH ADULT SPINAL DEFORMITY: A RETROSPECTIVE COHORT STUDY. THE AIMED OF THIS STUDY IS TO INVESTIGATE THE EFFICACY OF USING A 2-OCTYLCYANOACRYLATE ADHESIVE WITH A SELF-ADHESIVE POLYMER MESH TAPE (2OPMT) FOR PREVENTING SSI AFTER LONG-SEGMENT CORRECTIVE FUSION IN ADULT SPINAL DEFORMITY (ASD) PATIENTS BETWEEN 2010 AND 2021, WITH MINIMUM 1-YEAR FOLLOW-UP. FROM 2010 TO 2015, WOUNDS WERE CLOSED WITH SUBCUTICULAR SUTURES PLUS SKIN STAPLES (STAPLER GROUP, N = 267). FROM 2015 ONWARD, WOUNDS WERE CLOSED WITH SUBCUTICULAR CONTINUOUS SUTURES PLUS THE 2OPMT SYSTEM (2OPMT GROUP, N = 221). DERMABOND PRIMEO (ETH) WAS USED FOR NOVEL SKIN CLOSURE SYSTEM WITH COMBINED A POLYMER MESH TAPE WITH A TOPICAL CYANOACRYLATE GLUE. REPORTED COMPLICATIONS: 2OPMT (N=221) DERMABOND PRIMEO (ETH). SUPERFICIAL SURGICAL SITE INFECTION (SSI) (N=3) TREATMENT: MANAGED SUCCESSFULLY WITH DEBRIDEMENT AND TARGETED ANTIBIOTICS. DEEP SURGICAL SITE INFECTION (SSI) (N=3) TREA

  Patient problems: Unspecified Infection

  MAUDE report 24888375 ↗
• InjuryFeb 26, 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 PATIENT PRESENTED ALLERGIC REACTION WHEN USING ADHESIVE. REMOVAL OF THE SURGICAL GLUE BEFORE THE EXPECTED TIME. PRESCRIBED AN ANTIALLERGIC BY THE DOCTOR. ADDITIONAL INFORMATION HAS BEEN REQUESTED. -

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 24454012 ↗
• MalfunctionOct 28, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND A TOPICAL SKIN ADHESIVE WAS USED. DURING THE PROCEDURE, WHEN THE PRODUCT WAS OPENED FOR USE, IT WAS OBSERVED THAT THE LIQUID CONTENT OF THE APPLICATOR HAD A GREEN COLORATION, WHICH WAS NOT NORMAL, AND IT HAD A THICK CONSISTENCY AS IF IT WERE EXPIRED OR UNSUITABLE FOR USE. THE PRODUCT WAS WITHIN ITS EXPIRATION DATE AND WAS STORED ACCORDING TO THE MANUFACTURER¿S INSTRUCTIONS. THE ADHESIVE ITSELF WAS IN PERFECT CONDITION, BUT THE APPLICATOR COULD NOT BE USED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23407275 ↗
• InjurySep 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PATIENT UNDERWENT A CABG PROCEDURE ON AN UNKNOWN DATE IN 2025 AND A TOPICAL SKIN ADHESIVE WAS USED. PATIENT PRESENTED SUPERFICIAL INFECTION AFTER HOSPITAL DISCHARGE, SUSPECTED OF BEING AFTER THE USE OF ADHESIVE. ANTIBIOTIC PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Unspecified Infection

  MAUDE report 23072286 ↗
• InjuryAug 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PATIENT UNDERWENT A BREAST PROCEDURE ON (B)(6) 2025 AND TOPICAL SKIN ADHESIVE WAS USED. PATIENT HAD A REACTION TO ADHESIVE, USED IN BREAST CASE. REACTION OCCURRED IMMEDIATELY ON APPLICATION OF THE GLUE TO THE MESH, REACTION, RED SKIN AND HIVES. DRESSING APPLIED AND THEN GLUE. ALMOST IMMEDIATELY NOTICED AN ERYTHEMATOUS REACTION TO THE SKIN AROUND THE DRESSING. I WATCHED THE ERYTHEMA CONVALESCE AND EXTEND FOR AROUND ONE MINUTE. I THEN MADE THE DECISION TO REMOVE THE DRESSING. ADHESIVE WAS REMOVED IN THEATRE AND SKIN WASHED WITH SALINE HOWEVER INEVITABLY THE GLUE WILL HAVE REMAINED ON THE SKIN. USUAL ALTERNATIVE DRESSINGS APPLIED (MEPILEX BORDER). ADDITIONAL INFORMATION HAS BEEN REQUESTED.

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

  MAUDE report 22804796 ↗
• InjuryJul 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PATIENT UNDERWENT A POSTBARIATRIC BILATERAL BRACHIAL DERMOLIPECTOMY ON (B)(6) 2025 AND TOPICAL SKIN ADHESIVE WAS USED. HYPERSENSITIVITY REACTION OR CONTACT DERMATITIS SECONDARY TO SURGICAL GLUE AND/OR SCREEN USED IN POSTOPERATIVE DRESSING. PROCEDURE PERFORMED WITH THE USE OF SURGICAL GLUE AND STERILE ADHERENT SCREEN. TREATED WITH LORATADINE AND CLOBETASOL WERE USED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Erythema; Hypersensitivity/Allergic reaction; Insufficient Information; Skin Discoloration; Skin Inflammation/ Irritation

  MAUDE report 22482170 ↗
• InjuryJul 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PATIENT UNDERWENT A POST BARIATRIC BILATERAL BRACHIAL DERMOLIPECTOMY ON (B)(6) 2025 AND TOPICAL SKIN ADHESIVE WAS USED. HYPERSENSITIVITY REACTION OR CONTACT DERMATITIS SECONDARY TO SURGICAL GLUE AND/OR SCREEN USED IN POSTOPERATIVE DRESSING. PROCEDURE PERFORMED WITH THE USE OF SURGICAL GLUE AND STERILE ADHERENT SCREEN. TREATED WITH LORATADINE AND CLOBETASOL WERE USED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Erythema; Hypersensitivity/Allergic reaction; Insufficient Information; Skin Discoloration; Skin Inflammation/ Irritation

  MAUDE report 22482167 ↗
• InjuryJul 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED, A PATIENT UNDERWENT A BREAST RECONSTRUCTION PROCEDURE ON AN UNKNOWN DATE IN 2025 AND TOPICAL SKIN ADHESIVE WAS USED. POST OP, THE PATIENT PRESENTED WITH A REACTION OF BLISTERING. PATIENT WAS PRESCRIBED STEROIDS TO RELIEVE THE SYMPTOMS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blister

  MAUDE report 22398421 ↗
• InjuryJul 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PATIENT UNDERWENT A BREAST RECONSTRUCTION PROCEDURE ON AN UNKNOWN DATE IN 2025 AND TOPICAL SKIN ADHESIVE WAS USED. POST OP, THE PATIENT PRESENTED WITH A REACTION OF BLISTERING. PATIENT WAS PRESCRIBED STEROIDS TO RELIEVE THE SYMPTOMS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blister

  MAUDE report 22398406 ↗
• MalfunctionJun 17, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024 AND TOPICAL SKIN ADHESIVE WAS USED. MATERIAL IS UNSUITABLE FOR USE, A STRANGE LIQUID IS COMING OUT AND DAMAGES THE MATERIAL. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22241639 ↗
• InjuryMay 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN PLASTIC SURGERY ON (B)(6)2025 AND TOPICAL SKIN ADHESIVE WAS USED. OBSERVED AN ANAPHYLACTIC REACTION IN A PATIENT AT THE SITE OF THE PRODUCT, THE PATIENT PRESENTED A RED AREA AT THE SITE OF THE ADHESIVE, SHOWING AN ALLERGIC REACTION. PRODUCT WAS REMOVED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Anaphylactoid / Anaphylaxis; Erythema; Hypersensitivity/Allergic reaction

  MAUDE report 22064450 ↗
• InjuryMay 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN PLASTIC SURGERY ON (B)(6) 2025 AND TOPICAL SKIN ADHESIVE WAS USED. OBSERVED AN ANAPHYLACTIC REACTION IN A PATIENT AT THE SITE OF THE PRODUCT, THE PATIENT HAD ALREADY INFORMED THE MEDICAL TEAM THAT THEY HAVE ALLERGIES, AND CARE WAS TAKEN WITH SOME MATERIALS DURING THE SURGERY. UPON ARRIVING HOME, HE DEVELOPED AN ALLERGY TO ADHESIVE. PRODUCT WAS REMOVED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Anaphylactoid / Anaphylaxis; Hypersensitivity/Allergic reaction

  MAUDE report 22064449 ↗
• InjuryMay 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN PLASTIC SURGERY ON (B)(6) 2025 AND TOPICAL SKIN ADHESIVE WAS USED. OBSERVED AN ANAPHYLACTIC REACTION IN A PATIENT AT THE SITE OF THE PRODUCT, THE PATIENT PRESENTED A STRONG ALLERGIC REACTION ALL OVER HER BODY, REQUIRING HOSPITAL CARE AFTER DISCHARGE AND RETURNING TO THE HOSPITAL. THE PRODUCT MAINTAINED ON, "ON REQUEST" WITH THE PRESCRIPTION OF ANTIHISTAMINE AND CORTICOSTEROID. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Anaphylactoid / Anaphylaxis; Hypersensitivity/Allergic reaction

  MAUDE report 22064447 ↗
• InjuryFeb 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PATIENT UNDERWENT AN ABDOMINOPLASTY ON (B)(6) 2024 AND TOPICAL SKIN ADHESIVE WAS USED. NINE DAYS POST OP, THE PATIENT PRESENTED WITH A REACTION. THEY HAD A REDNESS AND A RASH ON THEIR TORSO. PREDNISONE TAPER WAS ADMINISTERED TO PATIENT. TOPICAL CREAM WAS CORTISONE GIVEN AS WELL AS BENADRYL AS NEEDED. NO DEVICE WILL BE RETURNED. NO PATIENT HARM WAS REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Erythema; Rash; Skin Inflammation/ Irritation

  MAUDE report 21293200 ↗
• InjuryNov 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN PLASTIC PROCEDURE ON AN UNKNOWN DATE IN 2024 AND TOPICAL SKIN ADHESIVE WAS USED. THE ADHESIVE WAS GIVING A SKIN REACTION, REQUIRING TOPICAL OR ORAL TREATMENT. NO CLAIMS WERE FILED. THAT IS ALL THE INFORMATION THAT WAS SHARED AT THIS TIME. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 20616875 ↗
• InjuryNov 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN PLASTIC PROCEDURE ON AN UNKNOWN DATE IN 2024 AND TOPICAL SKIN ADHESIVE WAS USED. THE ADHESIVE WAS GIVING A SKIN REACTION, REQUIRING TOPICAL OR ORAL TREATMENT. NO CLAIMS WERE FILED. THAT IS ALL THE INFORMATION THAT WAS SHARED AT THIS TIME. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 20614485 ↗
• InjuryNov 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PATIENT UNDERWENT AN ABDOMINOPLASTY ON (B)(6) 2024 AND TOPICAL SKIN ADHESIVE WAS USED. POST OP, THE PATIENT DEVELOPED A RASH OF HER ENTIRE "TRUNK" FRONT AND BACK THAT WAS RAISED, BUMPY, AND ITCHY. PATIENT RECEIVE ORALLY PREDNISONE. THE RASH TOOK ABOUT FOUR WEEKS TO RESOLVE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Itching Sensation; Skin Inflammation/ Irritation

  MAUDE report 20602448 ↗
• InjuryNov 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PATIENT UNDERWENT AN ABDOMINOPLASTY ON (B)(6) 2024 AND TOPICAL SKIN ADHESIVE WAS USED. POST OP, THE PATIENT DEVELOPED A RASH OF HER ENTIRE "TRUNK" FRONT AND BACK THAT WAS RAISED, BUMPY, AND ITCHY. PATIENT RECEIVE ORALLY PREDNISONE. THE RASH TOOK ABOUT FOUR WEEKS TO RESOLVE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Itching Sensation; Skin Inflammation/ Irritation

  MAUDE report 20601503 ↗
• 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 ABDOMINOPLASTY ON UNKNOWN DATE IN 2024 AND TOPICAL SKIN ADHESIVE WAS USED. THE PATIENT HAD A SKIN REACTION WITH ADHESIVE. PATIENT WAS SENT TO ER WITH SKIN REACTIONS. THEY STATED THEY WERE SEVERE ALLERGIC REACTIONS. PATIENT WAS HOSPITALIZED ON AN STEROID DRIP. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Hypersensitivity/Allergic reaction; Skin Inflammation/ Irritation

  MAUDE report 20521188 ↗
• InjuryOct 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PATIENT UNDERWENT AN BREAST SURGERY ON UNKNOWN DATE IN 2024 AND TOPICAL SKIN ADHESIVE WAS USED. THE PATIENT HAD A SKIN REACTION WITH ADHESIVE. PATIENT WAS SENT TO ER WITH SKIN REACTIONS. THEY STATED THEY WERE SEVERE ALLERGIC REACTIONS. PATIENT WAS HOSPITALIZED ON AN STEROID DRIP. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Hypersensitivity/Allergic reaction; Skin Inflammation/ Irritation

  MAUDE report 20518123 ↗
• InjuryOct 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PATIENT UNDERWENT AN BREAST SURGERY ON UNKNOWN DATE IN 2024 AND TOPICAL SKIN ADHESIVE WAS USED. THE PATIENT HAD A SKIN REACTION WITH ADHESIVE. PATIENT WAS SENT TO ER WITH SKIN REACTIONS. THEY STATED THEY WERE SEVERE ALLERGIC REACTIONS. PATIENT WAS HOSPITALIZED ON AN STEROID DRIP. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Hypersensitivity/Allergic reaction; Skin Inflammation/ Irritation

  MAUDE report 20517639 ↗
• InjuryOct 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PATIENT UNDERWENT AN BREAST SURGERY ON UNKNOWN DATE IN 2024 AND TOPICAL SKIN ADHESIVE WAS USED. THE PATIENT HAD A SKIN REACTION WITH ADHESIVE. PATIENT WAS SENT TO ER WITH SKIN REACTIONS. THEY STATED THEY WERE SEVERE ALLERGIC REACTIONS. PATIENT WAS HOSPITALIZED ON AN STEROID DRIP. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Hypersensitivity/Allergic reaction; Skin Inflammation/ Irritation

  MAUDE report 20517558 ↗