Medline MSC091040Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 10884389953044), received between Jun 8, 2018 and Mar 31, 2025 — classified as 12 injuries, 1 malfunction.

The most frequently reported specific device problem is “Unexpected Therapeutic Results” (2 reports).

1 other recall cover devices cleared under the same FDA submission (K132243); they may or may not involve this specific model.

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

• InjuryMar 31, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  ACCORDING TO THE CUSTOMER, ON (B)(6) 2025 THE PRODUCT WAS APPLIED TO A "SURGICAL CLOSURE". THE CUSTOMER REPORTED THE PATIENT "BROKE OUT IN A RASH" AFTER APPLICATION.

  Patient problems: Rash

  MAUDE report 21733360 ↗
• InjuryMar 31, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  ACCORDING TO THE FACILITY ON (B)(6) IN AN OR SURGERY, THE PRODUCT WAS BEING USED WHEN BEING APPLIED TO A SURGICAL CLOSURE IN THE OR. THE PATIENT EXPERIENCED A RASH AS A REACTION.

  Patient problems: Rash

  MAUDE report 21731520 ↗
• InjuryJun 14, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  REACTION REQUIRING ANTIBIOTICS AND BENEDRYL.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 17128896 ↗
• InjuryJan 10, 2023Material Integrity Problem; Material Integrity Problem

  ACCORDING TO THE FACILITY ON (B)(6) 2022 AFTER A SURGICAL CASE WAS COMPLETE "THE SCRUB TECH ACTIVATED SKINAFFIX BY SQUEEZING IT AND A PIECE OF GLASS CAME THROUGH THE PLASTIC OUTER COATING AND STUCK IN THEIR RIGHT THUMB".

  Patient problems: Laceration(s)

  MAUDE report 16130987 ↗
• InjuryFeb 23, 2022Unexpected Therapeutic Results

  IT WAS REPORTED THAT AFTER A PROCEDURE THE PRODUCT WAS APPLIED AND THE PATIENT EXPERIENCED DEHISCENCE OF THE INCISION AND AN INFECTION. FURTHER MEDICAL INTERVENTION WAS REQUIRED, THE PATIENT COMPLETING A COURSE OF ANTIBIOTICS. PATIENT FULLY RECOVERED WITHOUT ANY NEGATIVE EFFECTS.

  Patient problems: Unspecified Infection; Wound Dehiscence

  MAUDE report 13585518 ↗
• InjuryFeb 23, 2022Unexpected Therapeutic Results

  IT WAS REPORTED THAT AFTER A PROCEDURE THE PRODUCT WAS APPLIED AND THE PATIENT EXPERIENCED DEHISCENCE OF THE INCISION AND AN INFECTION. FURTHER MEDICAL INTERVENTION WAS REQUIRED WITH THE PATIENT COMPLETING A COURSE OF ANTIBIOTICS, HOWEVER, THE PATIENT MADE A FULL RECOVERY WITHOUT ANY NEGATIVE EFFECTS. FURTHER INFORMATION: IT WAS REPORTED THAT THE PATIENT EXPERIENCED IMPLANTATION OF A ST. JUDE LOOP RECORDER. THE SKIN AFFIX WAS APPLIED AFTER THE PROCEDURE WAS COMPLETED. THE PATIENT REPORTED DISCOMFORT AT THE SITE WITHIN 3 DAYS OF THE IMPLANT. THE PATIENT WAS BROUGHT BACK FOR A WOUND SITE INSPECTION ON DAY 7 ALL OF WHICH THE PATIENT HAD DEHISCENCE OF THE INCISION. THE PATIENT REQUIRED 10-14 DAYS OF (UNSPECIFIED) ANTIBIOTIC THERAPY AND EXPLANT OF THE DEVICE IN A HOSPITAL OPERATING ROOM OCCURRED 14-21 DAYS POST IMPLANT. THE CUSTOMER REPORTEDLY USED ALL OF THE REMAINING PRODUCT AND NO SAMPLE WAS RETURNED FOR EVALUATION.

  Patient problems: Unspecified Infection; Wound Dehiscence

  MAUDE report 13585423 ↗
• InjuryFeb 23, 2022Output Problem

  IT WAS REPORTED THAT AFTER A PROCEDURE THE PRODUCT WAS APPLIED AND THE PATIENT EXPERIENCED DEHISCENCE OF THE INCISION AND AN INFECTION. FURTHER MEDICAL INTERVENTION WAS REQUIRED, WITH THE PATIENT COMPLETING A COURSE OF ANTIBIOTICS, HOWEVER, THE PATIENT MADE A FULL RECOVERY WITHOUT ANY NEGATIVE EFFECTS. FURTHER INFORMATION: IT WAS REPORTED THAT THE PATIENT EXPERIENCED IMPLANTATION OF A ST. JUDE LOOP RECORDER. THE SKIN AFFIX WAS APPLIED AFTER THE PROCEDURE WAS COMPLETED. THE PATIENT REPORTED DISCOMFORT AT THE SITE WITHIN 3 DAYS OF THE IMPLANT. THE PATIENT WAS BROUGHT BACK FOR A WOUND SITE INSPECTION ON DAY 7 ALL OF WHICH THE PATIENT HAD DEHISCENCE OF THE INCISION. THE PATIENT REQUIRED 10-14 DAYS OF (UNSPECIFIED) ANTIBIOTIC THERAPY AND EXPLANT OF THE DEVICE IN A HOSPITAL OPERATING ROOM OCCURRED 14-21 DAYS POST IMPLANT. THE CUSTOMER REPORTEDLY USED ALL OF THE REMAINING PRODUCT AND NO SAMPLE WAS RETURNED FOR EVALUATION.

  Patient problems: Unspecified Infection; Wound Dehiscence

  MAUDE report 13585010 ↗
• InjuryNov 18, 2021Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER A PROCEDURE THE PRODUCT WAS APPLIED AND THE PATIENT EXPERIENCED DEHISCENCE OF THE INCISION AND AN INFECTION. FURTHER MEDICAL INTERVENTION WAS REQUIRED.

  Patient problems: Unspecified Infection; Wound Dehiscence

  MAUDE report 12840524 ↗
• InjuryNov 18, 2021Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER A PROCEDURE THE PRODUCT WAS APPLIED AND THE PATIENT EXPERIENCED DEHISCENCE OF THE INCISION AND AN INFECTION. FURTHER MEDICAL INTERVENTION WAS REQUIRED.

  Patient problems: Unspecified Infection; Wound Dehiscence

  MAUDE report 12840409 ↗
• InjuryNov 18, 2021Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER A PROCEDURE THE PRODUCT WAS APPLIED AND THE PATIENT EXPERIENCED DEHISCENCE OF THE INCISION AND AN INFECTION. FURTHER MEDICAL INTERVENTION WAS REQUIRED.

  Patient problems: Unspecified Infection; Wound Dehiscence

  MAUDE report 12840246 ↗
• MalfunctionSep 3, 2019Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN UNKNOWN NUMBER OF PATIENTS HAD DEHISCENCE OF THEIR LAPAROSCOPIC WOUNDS, WHICH WERE CLOSED USING SKIN AFFIX.

  Patient problems: Wound Dehiscence

  MAUDE report 8956132 ↗
• InjuryOct 17, 2018Structural Problem

  IT WAS REPORTED THAT A PIECE OF THE INNER GLASS AMPULE PIERCED THE SKIN AFFIX'S OUTER CASE RESULTING IN THE PHYSICIAN SUSTAINING A PUNCTURE INJURY TO HIS UNIDENTIFIED RIGHT FINGER. THE PIECE OF GLASS WAS SUCCESSFULLY RETRIEVED THROUGH USE OF FORCEPS.

  Patient problems: Laceration(s)

  MAUDE report 7974508 ↗
• InjuryJun 8, 2018Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WHO HAD AN UNIDENTIFIED ABDOMINAL SURGERY WHICH USED THE SKIN AFFIX TO CLOSE A WOUND RETURNED TO THE EMERGENCY DEPARTMENT "WITH WHAT APPEARED TO BE INFECTED WOUND WITH NECROTIC TISSUE COVERING THE WOUND BED".

  Patient problems: Post Operative Wound Infection

  MAUDE report 7581853 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K132243. One submission often covers many models, so check the product and lot details in each record.

• Z-1788-2022 · May 25, 2022 · Open, Classified
  a. Skin Adhesive McKesson LiquiBand Exceed 0.4 mL Liquid Dome Applicator Tip 2-Octyl Cyanoacrylate. Model Number: 122-LBXS. b. Skin Adhesive McKesson LiquiBand Exceed 0.8 mL Liqui