BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SERI SURGICAL SCAFFOLD (US)

    MDR report key: 5488607 · Received March 9, 2016

    Report

    Report Number
    8020862-2016-00020
    Event Type
    Injury
    Date Received
    March 9, 2016
    Date of Event
    June 15, 2015
    Report Date
    February 16, 2016
    Manufacturer
    ALLERGAN (MEDFORD)
    Product Code
    OXF
    PMA / PMN Number
    K123128
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MEDWATCH SENT TO FDA ON 04/07/2016.

    Additional Manufacturer Narrative · 1

    MEDWATCH SENT TO FDA ON 03/09/2016. (B)(4). THE REPORTED EVENTS ARE PHYSIOLOGICAL COMPLICATIONS, AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THESE EVENTS. FURTHER INFORMATION FROM THE REPORTER REGARDING EVENT, PRODUCT, OR PATIENT DETAILS HAS BEEN REQUESTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. THE DEVICE REMAINS IMPLANTED. THEREFORE NO ANALYSIS OR TESTING HAS BEEN DONE. DEVICE LABELING ADDRESSES THE REPORTED EVENTS OF EXTRUSION AND INFECTION AS FOLLOWS: "ADVERSE REACTIONS ARE THOSE TYPICALLY ASSOCIATED WITH SURGICALLY IMPLANTABLE MATERIALS, INCLUDING INFECTION, INFLAMMATION, ADHESION FORMATION, FISTULA FORMATION, AND EXTRUSION." THESE EVENTS ARE BEING REPORTED BECAUSE MEDICAL INTERVENTION WAS REQUIRED, ALTHOUGH DEVICE-RELATEDNESS HAS NOT BEEN ESTABLISHED.

    Description of Event or Problem · 1

    PATIENT REPORTED PLACEMENT OF SERI SURGICAL SCAFFOLD UNDER THE RIGHT ARM AS PART OF A "REDUCTION PROCEDURE." PATIENT EXPERIENCED "BLEEDING AND OOZING", "STAPH INFECTIONS", AND "THREE TO FOUR SMALL PIECES THAT WERE COMING OUT" WERE "REMOVED." PATIENT ALSO REPORTED THAT THE "WOUNDS ARE NOT HEALING." AND THEY HAVE BECOME "ANEMIC." THE EVENTS HAVE NOT BEEN CONFIRMED BY A PHYSICIAN. SEE MFG REPORT #8020862-2016-00019 FOR THE LEFT SIDE DEVICE. PATIENT'S PHYSICIAN CONFIRMED THE DEVICE HAD EXTRUDED. THE DEVICE WAS PLACED IN THE ARM TO SUPPORT BRACHIOPLASTY FOR EXCESS SKIN. THE DOCTOR BELIEVES THE MOBILITY OF THE IMPLANTATION SITE CONTRIBUTED TO THE EVENT. THE DOCTOR REPORTED THAT THE PATIENT WAS NON-COMPLIANT WITH POST-SURGICAL CARE, AND REFUSED TO COOPERATE WITH HIS RECOMMENDATIONS. THE PATIENT NEVER HAD A "STAPH INFECTION." THE DOCTOR'S DETERMINATION WAS THAT THE WOUND HEALING ISSUES WERE DUE TO THE PATIENT'S NON-COMPLIANCE WITH POST-SURGICAL PROTOCOLS, NOT THE DEVICE, AND THE "NON-STOP BLEEDING" AND "OOZING" WERE DUE TO THE EXTRUSION. THE DOCTOR DETERMINED THAT THE PATIENT'S REPORT OF ANEMIA WAS DUE TO A RECENT LIPOSUCTION PROCEDURE THAT REMOVED APPROXIMATELY 4 LITERS OF TISSUE, NOT THE DEVICE. THE DEVICE REMAINS IMPLANTED.

    Description of Event or Problem · 1

    PATIENT REPORTED PLACEMENT OF SERI SURGICAL SCAFFOLD UNDER THE RIGHT ARM AS PART OF A "REDUCTION PROCEDURE." PATIENT EXPERIENCED "BLEEDING AND OOZING", "STAPH INFECTIONS", AND "THREE TO FOUR SMALL PIECES THAT WERE COMING OUT" WERE "REMOVED." PATIENT ALSO REPORTED THAT THE "WOUNDS ARE NOT HEALING," AND THEY HAVE BECOME "ANEMIC." THE EVENTS HAVE NOT BEEN CONFIRMED BY A PHYSICIAN. SEE MFR REPORT #8020862-2016-00019 FOR THE LEFT SIDE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    145486 SERI SURGICAL SCAFFOLD (US) MESH, SURGICAL, ABSORBABLE, PLASTIC AND RECONSTRUCTIVE SURGERY OXF ALLERGAN (MEDFORD) P14030301A

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention