DERMABOND ADVANCED DNX6Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 10705031203549), received between Nov 23, 2021 and Apr 16, 2026 — classified as 10 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (2 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 16, 2026.

Most reported problems

Recent adverse event reports

The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• InjuryApr 16, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN SURGERY ON AN UNKNOWN DATE IN 2026 AND TOPICAL SKIN ADHESIVE WAS USED. PATIENT HAS A SEVERE SKIN REACTION TO ADHESIVE AND HAD TO BE HOSPITALIZED FOR THE REACTION. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 24894414 ↗
• MalfunctionDec 26, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  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 SQUEEZING OVER GLUE AREA TO ACTIVATE, THE SHARP PENETRATED DOUBLE LAYER PLASTIC AND STABBED THE STAFF MEMBER'S FINGER CAUSING A CUT. THERE WERE NO ADVERSE CONSEQUENCES REPORTED FOR THE STAFF MEMBER. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23896921 ↗
• 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)(60 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 23347822 ↗
• InjuryAug 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND TOPICAL SKIN ADHESIVE WAS USED TO CLOSE TROCAR PORT SITES. THE PATIENT EXPERIENCED A WOUND DEHISCENCE. IT WAS ALSO REPORTED THAT THE DEHISCENCE HAPPENED DUE TO USER ERROR/IMPROPER CLOSING OF PORT SITES. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Wound Dehiscence

  MAUDE report 22787708 ↗
• InjuryAug 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND TOPICAL SKIN ADHESIVE WAS USED TO CLOSE TROCAR PORT SITES. THE PATIENT EXPERIENCED A WOUND DEHISCENCE. IT WAS ALSO REPORTED THAT THE DEHISCENCE HAPPENED DUE TO USER ERROR/IMPROPER CLOSING OF PORT SITES. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Wound Dehiscence

  MAUDE report 22787704 ↗
• InjuryAug 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND TOPICAL SKIN ADHESIVE WAS USED TO CLOSE TROCAR PORT SITES. THE PATIENT EXPERIENCED A WOUND DEHISCENCE. IT WAS ALSO REPORTED THAT THE DEHISCENCE HAPPENED DUE TO USER ERROR/IMPROPER CLOSING OF PORT SITES. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Wound Dehiscence

  MAUDE report 22787703 ↗
• InjuryAug 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND TOPICAL SKIN ADHESIVE WAS USED TO CLOSE TROCAR PORT SITES. THE PATIENT EXPERIENCED A WOUND DEHISCENCE. T WAS ALSO REPORTED THAT THE DEHISCENCE HAPPENED DUE TO USER ERROR/IMPROPER CLOSING OF PORT SITES. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Wound Dehiscence

  MAUDE report 22787701 ↗
• InjuryAug 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND TOPICAL SKIN ADHESIVE WAS USED TO CLOSE TROCAR PORT SITES. THE PATIENT EXPERIENCED A WOUND DEHISCENCE. IT WAS ALSO REPORTED THAT THE DEHISCENCE HAPPENED DUE TO USER ERROR/IMPROPER CLOSING OF PORT SITES. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Wound Dehiscence

  MAUDE report 22787699 ↗
• InjuryAug 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND TOPICAL SKIN ADHESIVE WAS USED TO CLOSE TROCAR PORT SITES. THE PATIENT EXPERIENCED A WOUND DEHISCENCE. IT WAS ALSO REPORTED THAT THE DEHISCENCE HAPPENED DUE TO USER ERROR/IMPROPER CLOSING OF PORT SITES. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Wound Dehiscence

  MAUDE report 22787698 ↗
• MalfunctionAug 7, 2024Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE IN 2024 AND TOPICAL SKIN ADHESIVE WAS USED. DURING PRE-OP, THEY OPENED THE DEVICE AND NOTICED A HAIR INSIDE THE PACKAGING. OPENED ANOTHER TO COMPLETE CASE. DEVICE IS AVAILABLE FOR RETURN. NO HARM TO PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19927902 ↗
• MalfunctionJun 12, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED A PATIENT UNDEWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND TOPICAL SKIN ADHESIVE WAS USED. WHILE TRYING TO BREAK PEN AND CRUSH GLASS HOUSING TO RELEASE LIQUID, A PIECE OF GLASS PENETRATED THRU HOUSING AND POKED A NURSE.. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17110416 ↗
• InjuryMay 20, 2022Adverse 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 4/25/2022 AND TOPICAL SKIN ADHESIVE WAS USED. ADHESIVE WAS APPLIED ON THE CHEST. PATIENT PRESENTED WITH REDNESS OVER THE ENTIRE CHEST AREA, RECEDED WITH BENADRYL. PATIENT WAS STILL REPORTING PAIN. HEAT WITH APPLICATION, ADHESIVE REMOVED IN RECOVERY TO TRY AND MINIMIZE THE REACTION. STEROIDS AND BENADRYL GIVEN, TORADOL FOR PAIN. NO FURTHER INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

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

  MAUDE report 14457094 ↗
• InjuryNov 23, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PATIENT UNDERWENT A KNEE RECONSTRUCTION PROCEDURE ON (B)(6) 2021 AND TOPICAL SKIN ADHESIVE WAS USED. SEVEN DAYS POST OP, THE PATIENT DEVELOPED REDNESS AND ITCHING AT WOUND SITE. ON DAY TEN BLISTERS DEVELOPED. THE WOUND WAS CLEANED AND DRIED AND ON DAY FOURTEEN SHE SAW A DERMATOLOGIST WHO TREATED HER WITH TOPICAL STEROIDS AND SILVER SULFADIAZINE. SHE ALSO DEVELOPED SYSTEMIC SYMPTOMS WHICH WERE REDNESS, ITCHING, AND RASH ON ARMS, LEGS, AND TORSO. SHE IS DOING MUCH BETTER NOW. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blister; Hypersensitivity/Allergic reaction; Itching Sensation; Rash; Skin Inflammation/ Irritation

  MAUDE report 12862144 ↗