BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SERI SURGICAL SCAFFOLD (US)

    MDR report key: 4170558 · Received October 9, 2014

    Report

    Report Number
    3008374097-2014-00096
    Event Type
    Injury
    Date Received
    October 9, 2014
    Date of Event
    August 31, 2014
    Report Date
    September 8, 2014
    Manufacturer
    ALLERGAN
    Product Code
    OXF
    PMA / PMN Number
    K123128
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    FURTHER INFORMATION FROM THE REPORTER REGARDING EVENT, PRODUCT, OR PATIENT DETAILS HAS BEEN REQUESTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. THE EVENT OF "SEROPURULENT DRAINAGE AROUND THE IMPLANT," "ABSCESS" AND "BILATERAL BREAST INFECTION" ARE PHYSIOLOGICAL COMPLICATIONS AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THIS EVENT. THE PHYSICIAN DISCARDED THE DEVICE WHEN IT WAS EXPLANTED AND IT IS NO LONGER AVAILABLE FOR RETURN. THEREFORE, ALLERGAN WILL NOT RECEIVE IT AND NO ANALYSIS OR TESTING WILL BE DONE. DEVICE LABELING ADDRESSES THE REPORTED EVENTS OF "SEROPURULENT DRAINAGE AROUND THE IMPLANT," " ABSCESS" AND "BILATERAL BREAST 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

    EVENT OF LEFT "BREAST INFECTION" WITH AN ONSET DATE OF (B)(6) 2014 HAS BEEN REMOVED BY PHYSICIAN FROM CLINICAL REPORT AND HAS BEEN RULED OUT.

    Description of Event or Problem · 1

    PHYSICIAN REPORTED THAT FOLLOWING THE IMPLANT OF SERI ON (B)(6) 2014, THE PATIENT EXPERIENCED "SEROPURULENT DRAINAGE AROUND THE IMPLANT" AND "DRAINAGE 1 MONTH AGO UNDER THE LEFT BREAST 92 MONTH POST-SURGERY)." PER THE PATIENT, THE ONSET DATE OF THE DRAINAGE WAS (B)(6) 2014. THE STOP DATE WAS (B)(6) 2014. PHYSICIAN ADDITIONALLY REPORTED "ABSCESS" THAT IS "GRAM STAIN NEGATIVE BUT CULTURES ARE PENDING." PHYSICIAN REPORTED LEFT SIDE "BILATERAL BREAST INFECTION" WITH AN ONSET DATE OF (B)(6) 2014. THE OUTCOME IS ONGOING. THIS MEDWATCH REPRESENTS THE LEFT SIDE SERI DEVICE. ONE HUNDRED PERCENT OF THE SERI WAS EXPLANTED ON (B)(6) 2014. SEE MFR REPORT NUMBER 3008374097-2014-00097 FOR THE RIGHT SIDE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    636872 SERI SURGICAL SCAFFOLD (US) MESH, SURGICAL, ABSORBABLE, PLASTIC AND RECONSTRUCTIVE SURGERY OXF ALLERGAN NA P12071601

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention EXPLANTED:| IMPLANTED: