BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIGAMAX-5MM

    MDR report key: 2974488 · Received February 22, 2013

    Report

    Report Number
    3005075853-2013-00805
    Event Type
    Injury
    Date Received
    February 22, 2013
    Date of Event
    December 27, 2012
    Report Date
    January 25, 2013
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    FZP
    PMA / PMN Number
    K050344
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE WAS NOT RETURNED FOR EVALUATION. ATTEMPTS ARE BEING MADE TO OBTAIN ADDITIONAL INFORMATION. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE, A SUPPLEMENTAL MEDWATCH WILL BE SENT.

    Additional Manufacturer Narrative · 1

    (B)(4). THE FOLLOWING INFORMATION WAS OBTAINED BY THE PATIENT: THE PATIENT INFORMED HER SURGEON OF HER PREVIOUS CHALLENGES WITH THE CLIPS FROM THE HYSTERECTOMY PROCEDURE AND HE AGREED NOT TO USE CLIPS DURING THE CHOLECYSTECTOMY PROCEDURE. THE PATIENT PRESENTED WITH SYMPTOMS OF A RASH (SAME RASH AFTER THE HYSTERECTOMY) AROUND HER BULLY BUTTON WHICH HAS NOW TRAVELED TO HER FACE AND MOUTH. SHE EXPLAINED THE RASH TO BE SMALL BLISTERS. SHE IS NOW TAKING BENADRYL CAPSULES AND BENADRYL CREAM TO MITIGATE THE RASH. WHEN SHE DISCUSSED THE ISSUE WITH HER SURGEON HE EXPLAINED TO HER THAT HE DIDN'T FEEL SUTURES WOULD HOLD WHICH IS WHY HE MADE THE DECISION TO USE CLIPS. HE HAS AGREED TO REMOVE THE CLIPS, BUT SHE IS NOT COMFORTABLE WITH HIM OPERATING ON HER AGAIN SINCE HE DID NOT INFORM HER ABOUT THE USE OF CLIPS POST OP. SHE HAS SEEN A NUMBER OF OTHER SURGEONS IN REGARDS TO THE REMOVAL OF THE CLIPS, BUT NONE HAVE AGREED TO OPERATE ON HER. SHE HAS UNDERGONE TWO MELISA TESTS AND THE FIRST RESULTS CONFIRMED AN ALLERGY TO NICKEL AND ALUMINUM. THE SECOND TEST CONFIRMED ONLY AN ALLERGY TO NICKEL; HOWEVER, SHE WAS TAKING BENADRYL AT THE TIME OF THE TEST WHICH HER ALLERGIST EXPLAINED THAT WILL HAVE AN EFFECT ON THE RESULTS. EXPLAINED TO THE PATIENT THE LIGAMAX CLIPS DO NOT CONTAIN NICKEL OR ALUMINUM. SHE DID NOT WANT TO PROVIDE HER SURGEON'S OR ALLERGIST'S NAME FOR ANY COMMUNICATION BETWEEN THEM AND ETHICON. THE PATIENT IS STILL LOOKING FOR ANOTHER SURGEON AND PLANS TO HAVE THE CLIPS REMOVED WHEN POSSIBLE. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT POST-OP A CHOLECYSTECTOMY PROCEDURE ON (B)(6) 2012, THE PATIENT COMPLAINS OF PAIN IN THE RIGHT QUADRANT AND A RASH AT THE INCISION SITES. THEY HAVE SEEN THEIR PHYSICIAN AND THE PHYSICIAN PRESCRIBED CORTISONE CREAM FOR THE RASH. THE PAIN CONTINUES. THE PATIENT FURTHER STATES THEY HAD A HYSTERECTOMY IN 2010 AND THE SAME CLIPS WERE USED IN THAT PROCEDURE. AT THAT TIME THEY HAD THE SAME ALLERGIC REACTION. THE CLIPS FROM THE PROCEDURE HAD TO BE REMOVED. ONCE REMOVED, THE SYMPTOMS SUBSIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    78306 LIGAMAX-5MM CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention