BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DERMABOND ADVANCED TOPICAL SKIN ADHESIVE

    MDR report key: 5992377 · Received September 30, 2016

    Report

    Report Number
    2210968-2016-14155
    Event Type
    Malfunction
    Date Received
    September 30, 2016
    Date of Event
    September 15, 2016
    Report Date
    September 15, 2016
    Manufacturer
    ETHICON INC.
    Product Code
    MPN
    PMA / PMN Number
    K100423
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). TO DATE THE DEVICE HAS NOT BEEN RETURNED. IF THE DEVICE OR FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. ATTEMPTS ARE BEING MADE TO OBTAIN THE FOLLOWING INFORMATION. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. WAS THE DERMABOND BROKEN ACCORDING TO INSTRUCTIONS FOR USE (IFU)? WAS IT DIFFICULT TO BREAK THE AMPOULE (WAS EXTRA FORCE NEEDED TO BREAK THE AMPOULE)? WAS THE AMPOULE CRUSHED REPEATEDLY? DID THE GLASS PENETRATE THE USER¿S SKIN? WHAT WAS DONE TO TREAT THE SHARD PENETRATION? WAS MEDICAL OR SURGICAL INTERVENTION REQUIRED? WHAT IS THE STATUS OF THE SURGEON INJURY TODAY? WAS THE PRODUCT STERILIZED OR SUBJECTED TO ANY OTHER PROCESSES BEFORE APPLICATION? WHAT DIRECTION WAS THE APPLICATOR TIP POINTED? WHERE ON THE BULB DID THE DOCTOR SQUEEZE? HOW MUCH PRESSURE WAS APPLIED TO THE BULB? WHAT IS THE NAME OF THE SURGICAL PROCEDURE? CAN YOU IDENTIFY THE LOT NUMBER OF THE PRODUCT THAT WAS USED?

    Additional Manufacturer Narrative · 1

    DATE SENT TO THE FDA: 10/11/2016. ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: WAS THE DERMABOND BROKEN ACCORDING TO INSTRUCTIONS FOR USE (IFU)? YES. WAS IT DIFFICULT TO BREAK THE AMPOULE (WAS EXTRA FORCE NEEDED TO BREAK THE AMPOULE)? DNK. WAS THE AMPOULE CRUSHED REPEATEDLY? DNK. DID THE GLASS PENETRATE THE USER'S SKIN? NO. WHAT WAS DONE TO TREAT THE SHARD PENETRATION? N/A. WAS MEDICAL OR SURGICAL INTERVENTION REQUIRED? N/A. WHAT IS THE STATUS OF THE SURGEON INJURY TODAY? N/A. WAS THE PRODUCT STERILIZED OR SUBJECTED TO ANY OTHER PROCESSES BEFORE APPLICATION? N/A. WHAT DIRECTION WAS THE APPLICATOR TIP POINTED? DOWN. WHERE ON THE BULB DID THE DOCTOR SQUEEZE? MIDDLE. HOW MUCH PRESSURE WAS APPLIED TO THE BULB? DNK. WHAT IS THE NAME OF THE SURGICAL PROCEDURE? DNK. CAN YOU IDENTIFY THE LOT NUMBER OF THE PRODUCT THAT WAS USED? NO.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2016 AND THE TOPICAL SKIN ADHESIVE WAS USED. DURING THE PROCEDURE, WHEN THE SCRUB WENT TO CRACK THE TOPICAL SKIN ADHESIVE DEVICE, THEY WERE CONCERNED THAT THE GLASS WAS COMING THROUGH. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    641291 DERMABOND ADVANCED TOPICAL SKIN ADHESIVE ADHESIVE, TOPICAL SKIN MPN ETHICON INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1