BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DERMABOND ADVANCED

    MDR report key: 5884556 · Received August 17, 2016

    Report

    Report Number
    2210968-2016-11399
    Event Type
    Injury
    Date Received
    August 17, 2016
    Date of Event
    July 21, 2016
    Report Date
    July 27, 2016
    Manufacturer
    ETHICON INC.
    Product Code
    MPN
    PMA / PMN Number
    K100423
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, 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. ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: PROCEDURE NAME: LAPAROSCOPIC SALPINGECTOMY. PROCEDURE DATE: (B)(6) 2016. HOW THE DEVICE WAS USED (WHAT LAYER OF TISSUE AND HOW MANY LAYERS APPLIED)? SUPERFICIAL SKIN LAYER. LOCATION AND INCISION SIZE OF PRODUCT APPLICATION? 2-3 CM PORT SITES. WAS A DRESSING PLACED OVER THE INCISION? GAUZE PLACED OVER AREA AFTER SITE BEGAN OOZING (CLEAR YELLOW FLUID). DATE OF REACTION (B)(6) 2016. WHAT DOES THE REACTION LOOK LIKE? PLEASE PROVIDE DETAILS. REDNESS FOUR TIMES THE SIZE OF THE APPLICATION SITE, IRRITATION, OOZING. HOW LARGE OF AN AREA DOES THE REACTION COVER? REACTION EXTENDED BEYOND THE SITE, 4 TIMES THE AREA. WHAT WAS DONE TO ADDRESS THE REACTION? THE PATIENT (WHO HAPPENS TO BE A PHYSICIAN) REMOVED THE PRODUCT. WHAT TYPE OF MEDICATION? DOSE? WHEN (DATE) ADMINISTERED? PREDNISONE ¿ THREE TABLETS BY MOUTH QHS UNKNOWN DOSAGE, BENADRYL ONE TABLET BY MOUTH QHS, PEPCID AS NEEDED. WAS THE PRODUCT REMOVED? WAS ANOTHER METHOD USED TO CLOSE THE INCISION? YES, REMOVED. WAS THE SITE CULTURED? IF SO, WHAT BACTERIA WERE IDENTIFIED? NO. PRODUCT CODE AND LOT NUMBER INVOLVED DERMABOND ADVANCED ¿ SPECIFIC LOT UNKNOWN. WHAT IS THE MOST CURRENT PATIENT STATUS? REACTION STABLE. 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. WHAT PREP WAS USED PRIOR TO DERMABOND USE? WAS THE PREP ALLOWED TO DRY PRIOR TO PRINEO MESH APPLICATION? WAS INCISION RE-PREPPED BEFORE CLOSURE? IF SO, WITH WHAT? IF SO, WAS THE PREP ALLOWED TO DRY? WAS THE SKIN PREP SOLUTION WIPED OFF AND LET DRY BEFORE APPLYING ADHESIVE? DO YOU HAVE ANY PICTURES OF THE REACTION?

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A LAPAROSCOPIC SALPINGECTOMY PROCEDURE ON (B)(6) 2016 AND TOPICAL SKIN ADHESIVE WAS USED ON SUPERFICIAL SKIN LAYER AT LAPAROSCOPIC INCISIONS. FOLLOWING THE PROCEDURE, ON (B)(6) 2016, THE PATIENT DEVELOPED REDNESS, ITCHING, AND PAIN AT AND AROUND THE PORT SITES WHERE THE PRODUCT WAS USED. ON (B)(6) 2016, POST-OPERATIVE DAY FIVE, THE SYMPTOMS HAD WORSENED AND THE PATIENT WENT TO THE EMERGENCY DEPARTMENT FOR INCREASED REDNESS, IRRITATION, PAINFUL ITCHING AND SOME OOZING. THE GAUZE WAS PLACED OVER AREA AFTER SITE BEGAN OOZING WITH CLEAR YELLOW FLUID. THE REACTION AREA INCREASED TO FOUR TIMES THE SIZE OF THE APPLICATION AREA. THE PATIENT WAS PRESCRIBED PREDNISONE, BENADRYL AND PEPCID. THE PATIENT, WHO HAPPENS TO BE A PHYSICIAN, REMOVED THE TOPICAL SKIN ADHESIVE FROM THE SITES ON (B)(6) 2016 BY GENTLY PEELING IT AWAY FROM THE SKIN. THE PATIENT IS CURRENTLY ON ORAL MEDICATIONS AND HER SYMPTOMS HAVE REMAINED ABOUT THE SAME SINCE VISITING THE EMERGENCY DEPARTMENT. THE REACTION IS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    533728 DERMABOND ADVANCED ADHESIVE, TOPICAL SKIN MPN ETHICON INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1