BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SERI SURGICAL SCAFFOLD (US)

    MDR report key: 4212972 · Received October 24, 2014

    Report

    Report Number
    3008374097-2014-00107
    Event Type
    Injury
    Date Received
    October 24, 2014
    Date of Event
    August 12, 2014
    Report Date
    October 1, 2014
    Manufacturer
    ALLERGAN (MEDFORD)
    Product Code
    OXF
    PMA / PMN Number
    K123128
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENTS OF INFECTION, SCARRING, AND DELAYED HEALING ARE PHYSIOLOGICAL COMPLICATIONS, AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THESE EVENTS. DEVICE LABELING ADDRESSES THE REPORTED EVENT OF INFECTION AS FOLLOWS: ADVERSE REACTIONS ARE THOSE TYPICALLY ASSOCIATED WITH SURGICALLY IMPLANTABLE MATERIALS, INCLUDING INFECTION, INFLAMMATION, ADHESION FORMATION, FISTULA FORMATION, AND EXTRUSION.

    Additional Manufacturer Narrative · 1

    FURTHER INFO FROM THE REPORTER REGARDING THE EVENT DETAILS HAS BEEN REQUESTED. NO ADDITIONAL INFO IS AVAILABLE AT THIS TIME. THE EVENTS OF ERYTHEMA SYNDROME AND DAMAGE ARE PHYSIOLOGICAL COMPLICATIONS, AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THE EVENTS. THESE EVENTS ARE BEING REPORTED BECAUSE MEDICAL INTERVENTION WAS REQUIRED, ALTHOUGH DEVICE-RELATEDNESS HAS NOT BEEN ESTABLISHED.

    Description of Event or Problem · 1

    HEALTHCARE PROFESSIONAL REPORTED IMPLANTATION OF SERI AND CONCOMITANT BREAST IMPLANT ON (B)(6) 2014 DURING RIGHT SIDE AUGMENTATION MASTOPEXY SURGERY. POST-IMPLANTATION ON (B)(6) 2014, PATIENT PRESENTED WITH "DRAINAGE FROM RIGHT BREAST AND REDNESS". THE REDNESS WAS ISOLATED TO THE SKIN DIRECTLY OVERLYING THE SERITREATMENT INCLUDED SILVADENE AND ANTIBIOTICS. DEVICE REMAINS IMPLANTED AND IS UNAVAILABLE FOR RETURN. ADDITIONAL INFORMATION: HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE REVISION TO BREAST AUGMENTATION, AND A "SCARRED AREA FROM THE [SERIINFECTED AND NOW HEALED AREA OF SKIN INFERIOR TO THE NAC". UPON FOLLOW UP, THE PHYSICIAN'S OFFICE REPORTED THE PATIENT RECEIVED TREATMENT IN THE FORM OF ANTIBIOTICS CONSISTENT WITH AN INFECTION, ALTHOUGH NO INFECTIOUS AGENT WAS IDENTIFIED, AND HYPERBARIC OXYGEN THERAPY FOR WOUND HEALING ISSUES PRIOR TO THE PROCEDURE.

    Description of Event or Problem · 1

    HEALTHCARE PROFESSIONAL REPORTED IMPLANTATION OF SERI AND CONCOMITANT BREAST IMPLANT ON (B)(6) 2014 DURING RIGHT SIDE AUGMENTATION MASTOPEXY. POST-IMPLANTATION ON (B)(6) 2014, PT PRESENTED WITH "DRAINAGE FROM RIGHT BREAST AND REDNESS". THE REDNESS WAS ISOLATED TO THE SKIN DIRECTLY OVERLYING THE SERI. TREATMENT INCLUDED SILVADENE AND ANTIBIOTICS. DEVICE REMAINS IMPLANTED AND IS UNAVAILABLE FOR RETURN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    678576 SERI SURGICAL SCAFFOLD (US) MESH, SURGICAL, ABSORBABLE, PLASTIC AND RECONSTRUCTIVE SURGERY OXF ALLERGAN (MEDFORD) NA P12102201A

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention ALLERGAN SILICONE GEL IMPLANTS.