DERMABOND ADVANCED DNX12Recalls & reported problems

Summary

The FDA's MAUDE database contains 439 adverse event reports that list this exact device (DI 10705031203532), received between Nov 19, 2017 and Sep 11, 2026 — classified as 336 injuries, 103 malfunctions.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (49 reports).

1 FDA recall record name this device's identifier.

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.

Recalls naming this device

1. Jan 4, 2021Terminated

   Product distributed with a red tape as part of the sterile packaging which could impact the seal and result in a sterility breach

   Z-0953-2021 · Root cause: Packaging process control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 439 reports, in the reporter's own words as published by the FDA.

• InjurySep 11, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Erythema; Rash

  MAUDE report 50738914 ↗
• InjurySep 11, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Rash

  MAUDE report 50738901 ↗
• InjurySep 11, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Blister; Rash

  MAUDE report 50738894 ↗
• InjuryAug 27, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that a patient underwent an unknown procedure on (b)(6)2025 and topical skin adhesive was used. On (b)(6)2025 the patient was evaluated in surgeon's office and started on antibiotics. On 1-JAN-2026, the patient presented to ED for ongoing surgical site concerns. On 3-JAN-2026, the patient underwent surgical site wound washout. The patient was doing well at last visit (b)(6)026. Additional information was requested.

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 50484035 ↗
• InjuryAug 27, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that a patient underwent an unknown procedure on the neck and topical skin adhesive was used. The patient had a reaction. Patient was given Cephalexin 500mg two times a day. After course of antibiotics surgical site reaction cleared up. Additional information was requested.

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 50484033 ↗
• InjuryAug 11, 2026Adverse Event Without Identified Device or Use Problem

  It was reported a patient underwent a robotic Roux-en-Y gastric bypass procedure on (b)(6) 2026 and topical skin adhesive was used. The patient experienced a reaction on (b)(6) 2026. The patient developed a rash with red, raised bumps around the trocar port sites. Treatment included Benadryl, hydrocortisone, and Kenalog, administered twice daily for 7 days. The patient stated that the rash eventually resolved; however, complete resolution took approximately 10 to 12 days. No additional patient complications were reported. Device is not available for return. Additional information has been requested.

  Patient problems: Blister; Erythema; Rash

  MAUDE report 50210506 ↗
• InjuryAug 11, 2026Adverse Event Without Identified Device or Use Problem

  It was reported a patient underwent a laparoscopic cholecystectomy procedure on (b)(6) 2026 and topical skin adhesive was used. The patient experienced a reaction on (b)(6) 2026. The patient presented with a rash and redness around the trocar port sites. Treatment included Benadryl, hydrocortisone cream, and Diprolene ointment applied twice daily for 10 days. The reported symptoms resolved over approximately 6 to 8 weeks. No additional patient outcome information was provided. Device is not available for return. Additional information has been requested.

  Patient problems: Erythema; Rash

  MAUDE report 50210438 ↗
• InjuryAug 11, 2026Adverse Event Without Identified Device or Use Problem

  It was reported a patient underwent a robotic cholecystectomy procedure on (b)(6) 2026 and topical skin adhesive was used. The patient developed a rash with red, raised bumps around the trocar port sites. The patient was treated with Benadryl, hydrocortisone cream, and Kenalog cream applied twice daily for 7 to 10 days. No additional patient outcome information was provided. Device is not available for return. Additional information has been requested.

  Patient problems: Blister; Erythema; Rash

  MAUDE report 50210303 ↗
• InjuryAug 11, 2026Adverse Event Without Identified Device or Use Problem

  It was reported a patient underwent a robotic paraesophageal hiatal hernia repair with partial anterior fundoplication on (b)(6) 2026 and topical skin adhesive was used. The patient experienced a reaction on (b)(6) 2026. The patient developed a rash on the abdomen with raised bumps, redness, and itching around the trocar port sites. Treatment included oral Benadryl, hydrocortisone cream, Kenalog cream, and fluocinonide cream applied twice daily for 7 to 10 days. At the time of the report, the patient continued to experience some itching and redness. No further patient outcome information was provided. Device is not available for return. Additional information has been requested.

  Patient problems: Blister; Itching Sensation; Rash

  MAUDE report 50210244 ↗
• InjuryAug 11, 2026Adverse Event Without Identified Device or Use Problem

  It was reported a patient underwent a robotic cholecystectomy procedure on an unknown date and topical skin adhesive was used. The patient developed a rash around the trocar port sites on (b)(6)-2026. The patient was treated with Zyrtec, a Medrol Dose Pack, and hydrocortisone. No additional patient outcome information was provided. Device is not available for return. Additional information has been requested.

  Patient problems: Rash

  MAUDE report 50210183 ↗
• InjuryAug 6, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Skin Inflammation/ Irritation; Unspecified Infection

  MAUDE report 50155328 ↗
• MalfunctionMay 29, 2026Break; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED UPON OPENING PRODUCT ON 4-MAY-2026 AN ISSUE WAS OBSERVED WITH TOPICAL SKIN ADHESIVE. THE PRODUCT WAS VISIBLY DEFECTIVE WITHOUT OPENING THE PACKAGE. THE PRODUCT WAS NEVER OPENED AND WAS NOT USED IN SURGERY. OBSERVED THE DEFECT WHILE THE PRODUCT WAS ON THE SHELF. GLUE IN THE IN THE PACKAGING AS WELL AS A CRUSTY YELLOW/BROWN MATERIAL. THE DEVICE WILL BE RETURNED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25334214 ↗
• InjuryMay 19, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A ROBOTIC GENERAL SURGERY ON AN UNKNOWN DATE AND TOPICAL SKIN ADHESIVE WAS USED. POST OPERATIVELY, OVER THE LAST 3-6 MONTHS, THE PATIENT DEVELOPED A SKIN RASH AT THE PORT SITE CLOSURE. THE REACTION IS MILD ERYTHEMA ACROSS THE TOPICAL SKIN ADHESIVE BORDERS. DR. STATED THAT HE WOULD RECOMMEND THE PATIENT TO TAKE OTC BENADRYL AND PRESCRIBE ATARAX AND HYDROCORTISONE CREAM TO THE PATIENT. THE DEVICE IS NOT AVAILABLE FOR RETURN. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Erythema; Rash; Skin Inflammation/ Irritation

  MAUDE report 25221820 ↗
• InjuryMay 19, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A ROBOTIC GENERAL SURGERY ON AN UNKNOWN DATE AND TOPICAL SKIN ADHESIVE WAS USED. POST OPERATIVELY, OVER THE LAST 3-6 MONTHS, THE PATIENT DEVELOPED A SKIN RASH AT THE PORT SITE CLOSURE. THE REACTION IS MILD ERYTHEMA ACROSS THE TOPICAL SKIN ADHESIVE BORDERS. THE PATIENT ALSO DEVELOPED BLISTERS. DR. STATED THAT HE WOULD RECOMMEND THE PATIENT TO TAKE OTC BENADRYL AND PRESCRIBE ATARAX AND HYDROCORTISONE CREAM TO THE PATIENT. THE DEVICE IS NOT AVAILABLE FOR RETURN. ADDITIONAL INFORMATION WAS REQUESTED.

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

  MAUDE report 25221818 ↗
• InjuryMay 19, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A ROBOTIC GENERAL SURGERY ON AN UNKNOWN DATE AND TOPICAL SKIN ADHESIVE WAS USED. POST OPERATIVELY, OVER THE LAST 3-6 MONTHS, THE PATIENT DEVELOPED A SKIN RASH AT THE PORT SITE CLOSURE. THE REACTION IS MILD ERYTHEMA ACROSS THE TOPICAL SKIN ADHESIVE BORDERS. DR. STATED THAT HE WOULD RECOMMEND THE PATIENT TO TAKE OTC BENADRYL AND PRESCRIBE ATARAX AND HYDROCORTISONE CREAM TO THE PATIENT. THE DEVICE IS NOT AVAILABLE FOR RETURN. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Erythema; Rash; Skin Inflammation/ Irritation

  MAUDE report 25221813 ↗
• InjuryMay 19, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A ROBOTIC GENERAL SURGERY ON AN UNKNOWN DATE AND TOPICAL SKIN ADHESIVE WAS USED. POST OPERATIVELY, OVER THE LAST 3-6 MONTHS, THE PATIENT DEVELOPED A SKIN RASH AT THE PORT SITE CLOSURE. THE REACTION IS MILD ERYTHEMA ACROSS THE TOPICAL SKIN ADHESIVE BORDERS. THE PATIENT ALSO DEVELOPED BLISTERS. DR. STATED THAT HE WOULD RECOMMEND THE PATIENT TO TAKE OTC BENADRYL AND PRESCRIBE ATARAX AND HYDROCORTISONE CREAM TO THE PATIENT. THE DEVICE IS NOT AVAILABLE FOR RETURN. ADDITIONAL INFORMATION WAS REQUESTED.

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

  MAUDE report 25221806 ↗
• InjuryMay 6, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PATIENT UNDERWENT A ROBOTIC HYSTERECTOMY ON AN UNKNOWN DATE AND TOPICAL SKIN ADHESIVE WAS USED. VTHE PATIENT RETURNED POSTOPERATIVELY WITH AN ALLERGIC REACTION LOCALIZED TO ALL FOUR PORT SITES WHERE ADHESIVE WAS APPLIED. THE SURGEON EVALUATED THE PATIENT AND DIAGNOSED A ADHESIVE ALLERGY. THE PATIENT WAS TREATED WITH PRESCRIBED ORAL ANTIHISTAMINES AND TOPICAL CORTICOSTEROIDS. RESOLUTION OF THE RASH REQUIRED APPROXIMATELY ONE MONTH. AFTER THE RASH RESOLVED, RESIDUAL HYPERPIGMENTATION/DARKENED SKIN REMAINED AT THE AFFECTED SITES. DEVICE IS NOT AVAILABLE FOR RETURN AS IT HAS BEEN DISCARDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Rash; Skin Discoloration; Skin Inflammation/ Irritation

  MAUDE report 25097154 ↗
• InjuryApr 16, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN LAPAROSCOPIC ROBOTIC PROCEDURE ON AN UNKNOWN DATE IN 2026 AND TOPICAL SKIN ADHESIVE WAS USED. THE SURGEON SAW SKIN REACTIONS OR ALLERGIC REACTIONS ON PATIENT THE SURGEON HAS TO TREAT THE PATIENTS WITH STEROIDS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

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

  MAUDE report 24903231 ↗
• InjuryApr 16, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN LAPAROSCOPIC ROBOTIC PROCEDURE ON AN UNKNOWN DATE IN 2026 AND TOPICAL SKIN ADHESIVE WAS USED. THE SURGEON SAW SKIN REACTIONS OR ALLERGIC REACTIONS ON PATIENT THE SURGEON HAS TO TREAT THE PATIENTS WITH STEROIDS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

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

  MAUDE report 24895173 ↗
• MalfunctionApr 15, 2026Patient Device Interaction Problem

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND TOPICAL SKIN ADHESIVE WAS USED. WHEN SCRUB BROKE VIAL TO RELEASE SOLUTION, A SHARD BROKE THROUGH THE PLASTIC OUTER SHEATH AND CUT SCRUB. BECAUSE SHE WAS WEARING GLOVES FROM ENTIRE CASE, THEY CONSIDERED POSSIBLE CONTAMINATED SHARP TO EMPLOYEE. THERE WAS NO PATIENT CONSEQUENCE REPORTED. ONE DEVICE RETURNING. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24888515 ↗
• InjuryApr 3, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AND UNKNOWN DATE AND TOPICAL SKIN ADHESIVE WAS USED. PATIENT HAD ALLERGIC CONTACT DERMATITIS BLISTERING ERYTHEMATOUS RASH DIRECTLY OVER THE INCISION PATIENT REPORT ASSOCIATED BURNING, ITCHING SYMPTOMS AND DRAINAGE TREATMENT INCLUDES TOPICAL STEROIDS, +/- ORAL ANTIBIOTICS HIGHLY DISTRESSING FOR PATIENT ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blister; Burning Sensation; Distress; Erythema; Fluid Discharge; Itching Sensation; Rash; Skin Inflammation/ Irritation

  MAUDE report 24777688 ↗
• InjuryApr 3, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PATIENT UNDERWENT A TOTAL KNEE PROCEDURE ON (B)(6) 2025 AND TOPICAL SKIN ADHESIVE WAS USED. PATIENT HAD ALLERGIC CONTACT DERMATITIS. BLISTERING ERYTHEMATOUS RASH DIRECTLY OVER THE INCISION. PATIENT REPORT ASSOCIATED BURNING, ITCHING SYMPTOMS AND DRAINAGE. TREATMENT INCLUDES TOPICAL STEROIDS, +/- ORAL ANTIBIOTICS. HIGHLY DISTRESSING FOR PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blister; Burning Sensation; Distress; Erythema; Fluid Discharge; Itching Sensation; Rash; Sepsis; Skin Inflammation/ Irritation; Unspecified Infection

  MAUDE report 24777661 ↗
• InjuryApr 3, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PATIENT UNDERWENT A TOTAL KNEE PROCEDURE ON (B)(6) 2025 AND TOPICAL SKIN ADHESIVE WAS USED. PATIENT HAD ALLERGIC CONTACT DERMATITIS BLISTERING ERYTHEMATOUS RASH DIRECTLY OVER THE INCISION. PATIENT REPORT ASSOCIATED BURNING, ITCHING SYMPTOMS AND DRAINAGE TREATMENT INCLUDES TOPICAL STEROIDS, +/- ORAL ANTIBIOTICS. HIGHLY DISTRESSING FOR PATIENT ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blister; Burning Sensation; Distress; Erythema; Fluid Discharge; Itching Sensation; Rash; Skin Inflammation/ Irritation

  MAUDE report 24777618 ↗
• InjuryApr 3, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PATIENT UNDERWENT A TOTAL KNEE PROCEDURE ON UNKNOWN DAY IN (B)(6) 2025 AND TOPICAL SKIN ADHESIVE WAS USED. PATIENT HAD ALLERGIC CONTACT DERMATITIS. BLISTERING ERYTHEMATOUS RASH DIRECTLY OVER THE INCISION. PATIENT REPORT ASSOCIATED BURNING, ITCHING SYMPTOMS AND DRAINAGE. TREATMENT INCLUDES TOPICAL STEROIDS, +/- ORAL ANTIBIOTICS. HIGHLY DISTRESSING FOR PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blister; Burning Sensation; Distress; Erythema; Fluid Discharge; Itching Sensation; Rash; Skin Inflammation/ Irritation

  MAUDE report 24777600 ↗
• InjuryApr 3, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PATIENT UNDERWENT A TOTAL KNEE PROCEDURE ON (B)(6) 2026 AND TOPICAL SKIN ADHESIVE WAS USED. PATIENT HAD ALLERGIC CONTACT DERMATITIS BLISTERING ERYTHEMATOUS RASH DIRECTLY OVER THE INCISION PATIENT REPORT ASSOCIATED BURNING, ITCHING SYMPTOMS AND DRAINAGE TREATMENT INCLUDES TOPICAL STEROIDS, +/- ORAL ANTIBIOTICS HIGHLY DISTRESSING FOR PATIENT ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blister; Burning Sensation; Distress; Erythema; Fluid Discharge; Itching Sensation; Rash; Skin Inflammation/ Irritation

  MAUDE report 24777563 ↗