DERMABOND DHVM12Recalls & reported problems

Summary

The FDA's MAUDE database contains 44 adverse event reports that list this exact device (DI 10705031203525), received between Mar 29, 2018 and Dec 4, 2025 — classified as 29 injuries, 15 malfunctions.

The most frequently reported specific device problem is “Break” (10 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 44 reports, in the reporter's own words as published by the FDA.

• InjuryDec 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN EXCISIONAL BIOPSY ON THE ELBOW ON (B)(6) 2025 AND A TOPICAL SKIN ADHESIVE WAS USED. DURING THE PATIENT'S POSTOPERATIVE FOLLOW-UP VISIT, THE PATIENT EXPERIENCED A SKIN REACTION TO THE SKIN ADHESIVE. THE REACTION HAPPENED ALMOST IMMEDIATELY AND WAS ALL AROUND 6CM WITH BLISTERING. MEDICAL TREATMENT WAS REMOVAL OF THE ADHESIVE. THE PATIENT REQUIRED TRIMMING OF NECROSED TISSUE ON THE ELBOW. NO MEDICATION WAS REQUIRED. THE DEVICE WAS DISCARDED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Blister; Necrosis; Skin Inflammation/ Irritation

  MAUDE report 23716994 ↗
• InjuryOct 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A ROBOTIC SURGERY ON (B)(6) 2025 AND A TOPICAL SKIN ADHESIVE WAS USED OVER THE INCISIONS/SUTURES. ON (B)(6) 2025, THE PATIENT COMPLAINED OF WORSENING ERYTHEMA SURROUNDING THE INCISIONS. INFECTION WAS RULED OUT. THE PATIENT DEVELOPED WORSENING ITCHING CONSISTENT WITH AN ALLERGIC REACTION. CONCERNED THAT THE TOPICAL SKIN ADHESIVE WAS THE CAUSE. THERE WAS IMPROVEMENT WITH A MEDROL DOSE PACK. ADDITIONAL INFORMATION WAS REQUESTED.

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

  MAUDE report 23347825 ↗
• InjuryFeb 4, 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 AND TOPICAL SKIN ADHESIVE WAS USED. A PATIENT WITH A REACTION TO ADHESIVE WAS REPORTED. THIS TIME WITH A DIFFERENT SURGEON. THE PATIENT WAS PREGNANT AND WILL NEED TO BE ON ORAL STEROIDS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 21305815 ↗
• InjuryDec 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 PROCEDURE ON AN UNKNOWN DATE IN 2024 AND TOPICAL SKIN ADHESIVE WAS USED. SURGEON HAD USED ADHESIVE FOR PATIENT AND EXPERIENCED SWELLING AND REDNESS AROUND THE SURGERY SITE. DEVICE IS NOT AVAILABLE FOR RETURN. REACTION OCCURRED POSTOPERATIVELY AND APPEARED LIKE CIRCLES AROUND THE GLUE. WE INSTRUCTED THE PATIENT TO REMOVE THE GLUE BUT THE REACTION REMAINED NECESSITATING BOTH LOCAL AND PO STEROIDS. AFTER A 7DAY COURSE OF ORAL STEROIDS, THE REACTION SUBSIDED OVER WEEKS. CURRENTLY BACK TO NORMAL. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Erythema; Swelling/ Edema

  MAUDE report 20859400 ↗
• InjuryDec 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 PROCEDURE ON AN UNKNOWN DATE IN 2024 AND TOPICAL SKIN ADHESIVE WAS USED. SURGEON HAD USED ADHESIVE FOR PATIENT AND EXPERIENCED SWELLING AND REDNESS AROUND THE SURGERY SITE. DEVICE IS NOT AVAILABLE FOR RETURN. REACTION OCCURRED POSTOPERATIVELY AND APPEARED LIKE CIRCLES AROUND THE GLUE. WE INSTRUCTED THE PATIENT TO REMOVE THE GLUE BUT THE REACTION REMAINED NECESSITATING BOTH LOCAL AND PO STEROIDS. AFTER A 7DAY COURSE OF ORAL STEROIDS, THE REACTION SUBSIDED OVER WEEKS. CURRENTLY BACK TO NORMAL. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Erythema; Swelling/ Edema

  MAUDE report 20858448 ↗
• InjuryDec 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 PROCEDURE ON AN UNKNOWN DATE IN 2024 AND TOPICAL SKIN ADHESIVE WAS USED. SURGEON HAD USED ADHESIVE FOR PATIENT AND EXPERIENCED SWELLING AND REDNESS AROUND THE SURGERY SITE. DEVICE IS NOT AVAILABLE FOR RETURN. REACTION OCCURRED POSTOPERATIVELY AND APPEARED LIKE CIRCLES AROUND THE GLUE. WE INSTRUCTED THE PATIENT TO REMOVE THE GLUE BUT THE REACTION REMAINED NECESSITATING BOTH LOCAL AND PO STEROIDS. AFTER A 7DAY COURSE OF ORAL STEROIDS, THE REACTION SUBSIDED OVER WEEKS. CURRENTLY BACK TO NORMAL. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Erythema; Swelling/ Edema

  MAUDE report 20858358 ↗
• InjuryDec 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 PROCEDURE ON AN UNKNOWN DATE IN 2024 AND TOPICAL SKIN ADHESIVE WAS USED. SURGEON HAD USED ADHESIVE FOR PATIENT AND EXPERIENCED SWELLING AND REDNESS AROUND THE SURGERY SITE. DEVICE IS NOT AVAILABLE FOR RETURN. REACTION OCCURRED POSTOPERATIVELY AND APPEARED LIKE CIRCLES AROUND THE GLUE. WE INSTRUCTED THE PATIENT TO REMOVE THE GLUE BUT THE REACTION REMAINED NECESSITATING BOTH LOCAL AND PO STEROIDS. AFTER A 7 DAY COURSE OF ORAL STEROIDS, THE REACTION SUBSIDED OVER WEEKS. CURRENTLY BACK TO NORMAL. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Erythema; Swelling/ Edema

  MAUDE report 20857572 ↗
• InjuryDec 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 PROCEDURE ON AN UNKNOWN DATE IN 2024 AND TOPICAL SKIN ADHESIVE WAS USED. SURGEON HAD USED ADHESIVE FOR PATIENT AND EXPERIENCED SWELLING AND REDNESS AROUND THE SURGERY SITE. DEVICE IS NOT AVAILABLE FOR RETURN. REACTION OCCURRED POSTOPERATIVELY AND APPEARED LIKE CIRCLES AROUND THE GLUE. WE INSTRUCTED THE PATIENT TO REMOVE THE GLUE BUT THE REACTION REMAINED NECESSITATING BOTH LOCAL AND PO STEROIDS. AFTER A 7DAY COURSE OF ORAL STEROIDS, THE REACTION SUBSIDED OVER WEEKS. CURRENTLY BACK TO NORMAL. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Erythema; Swelling/ Edema

  MAUDE report 20856930 ↗
• InjuryDec 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 PROCEDURE ON AN UNKNOWN DATE IN 2024 AND TOPICAL SKIN ADHESIVE WAS USED. SURGEON HAD USED ADHESIVE FOR PATIENT AND EXPERIENCED SWELLING AND REDNESS AROUND THE SURGERY SITE. DEVICE IS NOT AVAILABLE FOR RETURN. REACTION OCCURRED POSTOPERATIVELY AND APPEARED LIKE CIRCLES AROUND THE GLUE. WE INSTRUCTED THE PATIENT TO REMOVE THE GLUE BUT THE REACTION REMAINED NECESSITATING BOTH LOCAL AND PO STEROIDS. AFTER A 7 DAY COURSE OF ORAL STEROIDS, THE REACTION SUBSIDED OVER WEEKS. CURRENTLY BACK TO NORMAL. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Erythema; Swelling/ Edema

  MAUDE report 20856400 ↗
• InjuryDec 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 PROCEDURE ON AN UNKNOWN DATE IN 2024 AND TOPICAL SKIN ADHESIVE WAS USED. SURGEON HAD USED ADHESIVE FOR PATIENT AND EXPERIENCED SWELLING AND REDNESS AROUND THE SURGERY SITE. DEVICE IS NOT AVAILABLE FOR RETURN. REACTION OCCURRED POSTOPERATIVELY AND APPEARED LIKE CIRCLES AROUND THE GLUE. WE INSTRUCTED THE PATIENT TO REMOVE THE GLUE BUT THE REACTION REMAINED NECESSITATING BOTH LOCAL AND PO STEROIDS. AFTER A 7DAY COURSE OF ORAL STEROIDS, THE REACTION SUBSIDED OVER WEEKS. CURRENTLY BACK TO NORMAL. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Erythema; Swelling/ Edema

  MAUDE report 20856354 ↗
• InjuryDec 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 PROCEDURE ON AN UNKNOWN DATE IN 2024 AND TOPICAL SKIN ADHESIVE WAS USED. SURGEON HAD USED ADHESIVE FOR PATIENT AND EXPERIENCED SWELLING AND REDNESS AROUND THE SURGERY SITE. DEVICE IS NOT AVAILABLE FOR RETURN. REACTION OCCURRED POSTOPERATIVELY AND APPEARED LIKE CIRCLES AROUND THE GLUE. WE INSTRUCTED THE PATIENT TO REMOVE THE GLUE BUT THE REACTION REMAINED NECESSITATING BOTH LOCAL AND PO STEROIDS. AFTER A 7DAY COURSE OF ORAL STEROIDS, THE REACTION SUBSIDED OVER WEEKS. CURRENTLY BACK TO NORMAL. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Erythema; Swelling/ Edema

  MAUDE report 20856249 ↗
• InjuryDec 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 PROCEDURE ON AN UNKNOWN DATE IN 2024 AND TOPICAL SKIN ADHESIVE WAS USED. SURGEON HAD USED ADHESIVE FOR PATIENT AND EXPERIENCED SWELLING AND REDNESS AROUND THE SURGERY SITE. DEVICE IS NOT AVAILABLE FOR RETURN. REACTION OCCURRED POSTOPERATIVELY AND APPEARED LIKE CIRCLES AROUND THE GLUE. WE INSTRUCTED THE PATIENT TO REMOVE THE GLUE BUT THE REACTION REMAINED NECESSITATING BOTH LOCAL AND PO STEROIDS. AFTER A 7DAY COURSE OF ORAL STEROIDS, THE REACTION SUBSIDED OVER WEEKS. CURRENTLY BACK TO NORMAL. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Erythema; Swelling/ Edema

  MAUDE report 20855955 ↗
• MalfunctionSep 16, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024 AND TOPICAL SKIN ADHESIVE WAS USED. THE NURSE USING THIS WENT TO CRACK THIS OPEN AND THE GLASS CAME THROUGH THE SIDE OF THE TUBE AND CUT HIM. THERE WAS NO PATIENT CONSEQUENCES REPORTED. THERE WAS NO SURGICAL DELAY. ONE DEVICE RETURNING. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20230364 ↗
• MalfunctionAug 13, 2024Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN SURGERY ON AN UNKNOWN DATE AND A TOPICAL SKIN ADHESIVE WAS USED. A HAIR OR A BLACK PARTICLE INSIDE THE PACKAGING. THERE WAS NO PATIENT CONSEQUENCES REPORTED. DEVICE WAS AVAILABLE FOR RETURN. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19977186 ↗
• MalfunctionJul 25, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND TOPICAL SKIN ADHESIVE WAS USED. THE RESIDENT PHYSICIAN EXPERIENCED A SMALL GLASS SHARD WHEN CRACKING A AMPOULE, RESULTED IN EXPOSURE TO A PATIENT¿S BLOOD. THE GLASS SHARD STICKING OUTSIDE THE VIAL. ' BLOOD TESTING PERFORMED AND PRESSURE WAS HELD TO FINGER TO STOP BLEEDING. CURRENT CONDITION OF SURGEON IS HEALED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17391000 ↗
• MalfunctionApr 21, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED A PATIENT UNDEWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE IN 2023 AND TOPICAL SKIN ADHESIVE WAS USED. DR CRACKED THE VIAL OF THE ADHESIVE AND UNKNOWINGLY, A SHARD OF THE GLASS AMPULE PIERCED THE PLASTIC HOUSING OF IT. UPON APPLICATION OF THE MD'S FINGER WAS SCRATCHED BY THIS GLASS SHARD, WHICH PIERCED THROUGH HIS GLOVES AND LEFT A SUPERFICIAL SCRATCH ON HIS FINGER. THERE WAS NO TREATMENT OR INTERVENTION PERFORMED. DR STATUS IS FINE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. UNKNOWN IF THE DEVICE IS AVAILABLE FOR RETURN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16790598 ↗
• MalfunctionJan 5, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED A PATIENT UNDERWENT A CABG PROCEDURE ON (B)(6) 2022 AND TOPICAL SKIN ADHESIVE WAS USED. DURING USE,WHEN MIXING THE PRODUCT THE AMPULE BROKE AND A SHARD OF GLASS PIERCED THE ASSISTANT'S GLOVE. NO INJURY WAS SUSTAINED TO THE USER. NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16109335 ↗
• InjuryDec 8, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PATIENT UNDERWENT AN KELOID SCAR ON (B)(6) 2021 AND TOPICAL SKIN ADHESIVE WAS USED. POST-OP PATIENT BROKE OUT IN A RASH. RASH TO INCISION LINE, ADHESIVE REMOVED, (B)(6) 2021 AND PRESCRIBED MEDROL DOES PACK (B)(6) 2021, THERE WAS NO FURTHER INFORMATION REPORTED. DEVICE IS NOT AVAILABLE FOR RETURN. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Rash

  MAUDE report 12962293 ↗
• InjuryDec 8, 2021Adverse 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) 2021 AND TOPICAL SKIN ADHESIVE WAS USED. POST-OP PATIENT BROKE OUT IN A RASH. RASH TO INCISION LINE, SEVERE ITCHING. MEDROL DOES PACK PRESCRIBED ON (B)(6) 2021; STEROID SHOT ADMINISTERED ON (B)(6) 2021. CURRENT PATIENT STATUS: UNRESOLVED ITCHING, RASH IMPROVED ON (B)(6) 2021. THERE WAS NO FURTHER INFORMATION REPORTED. DEVICE IS NOT AVAILABLE FOR RETURN. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Rash

  MAUDE report 12962243 ↗
• InjuryDec 8, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PATIENT UNDERWENT AN AUGMENTATION ON (B)(6) 2021 AND TOPICAL SKIN ADHESIVE WAS USED. POST-OP PATIENT BROKE OUT IN A RASH. RASH TO INCISION LINE, CHEST, BRA-LINE WITH SEVERE ITCHING ADHESIVE REMOVED, STEROID CREAM PRESCRIBED FOR PATIENT TO USE. ON (B)(6) 2021, CURRENT PATIENT STATUS: RASH RESOLVED. MILD ITCHING AT INCISIONS ON (B)(6) 2021. THERE WAS NO FURTHER INFORMATION REPORTED. DEVICE IS NOT AVAILABLE FOR RETURN. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Rash

  MAUDE report 12962224 ↗
• MalfunctionJun 17, 2020Break; Break

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) /2020 AND TOPICAL SKIN ADHESIVE WAS USED. THE VIAL BROKE AND PUNCTURED THE GLOVE OF THE USER. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10164140 ↗
• MalfunctionOct 29, 2019Break; Break

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2019 AND TOPICAL SKIN ADHESIVE WAS USED. THE PHYSICIAN CRUSHED THE AMPULE TO RELEASE THE LIQUID AND IT BROKE INTO MANY SHARDS. THE GLASS SHARDS DID NOT PENETRATE THE TUBE. THE FLUID ALSO WENT TO THE BACK OF THE DEVICE INSTEAD OF TOWARD THE APPLICATOR. NO ONE (PATIENT OR STAFF) WAS INJURED AS A RESULT. THERE WERE NO ADVERSE PATIENT CONSEQUENCES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9249840 ↗
• MalfunctionOct 29, 2019Break; Break

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2019 AND TOPICAL SKIN ADHESIVE WAS USED. THE PHYSICIAN CRUSHED THE AMPULE TO RELEASE THE LIQUID AND IT BROKE INTO MANY SHARDS. THE GLASS SHARDS DID NOT PENETRATE THE TUBE. THE FLUID ALSO WENT TO THE BACK OF THE DEVICE INSTEAD OF TOWARD THE APPLICATOR. NO ONE (PATIENT OR STAFF) WAS INJURED AS A RESULT. THERE WERE NO ADVERSE PATIENT CONSEQUENCES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9249829 ↗
• MalfunctionOct 29, 2019Break; Break

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2019 AND TOPICAL SKIN ADHESIVE WAS USED. THE PHYSICIAN CRUSHED THE AMPULE TO RELEASE THE LIQUID AND IT BROKE INTO MANY SHARDS. THE GLASS SHARDS DID NOT PENETRATE THE TUBE. THE FLUID ALSO WENT TO THE BACK OF THE DEVICE INSTEAD OF TOWARD THE APPLICATOR. NO ONE (PATIENT OR STAFF) WAS INJURED AS A RESULT. THERE WERE NO ADVERSE PATIENT CONSEQUENCES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9249734 ↗
• MalfunctionApr 22, 2019Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN ULTRASOUND PROCEDURE ON (B)(6) 2019 AND TOPICAL SKIN ADHESIVE WAS USED. THE ADHESIVE TUBE HAD A SHARD ATTACHED TO THE TUBE. THE PHYSICIAN WAS APPLYING IT AND THE PHYSICIAN'S GLOVE WAS CUT. CASE COMPLETED WITH ANOTHER DEVICE OF THE SAME PRODUCT CODE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. NO DEVICE WILL BE RETURNED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8537063 ↗