BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK TISSUE EXPANDER

    MDR report key: 3122155 · Received May 17, 2013

    Report

    Report Number
    2024601-2013-00396
    Event Type
    Injury
    Date Received
    May 17, 2013
    Date of Event
    April 12, 2013
    Report Date
    April 16, 2013
    Manufacturer
    ALLERGAN
    Product Code
    LCJ
    PMA / PMN Number
    K862203
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE REPORTER OF THE COMPLAINT WAS ASKED TO RETURN THE PRODUCT FOR ANALYSIS AS WELL AS INDICATE THE PRODUCT SERIAL NUMBER, DATE OF EVENT, IMPLANT DATE AND EXPLANT DATE. ALLERGAN HAS NOT RECEIVED THE PRODUCT AT THIS TIME. THEREFORE, NO ANALYSIS OR TESTING HAS BEEN DONE. MULTIPLE REQUESTS FOR FURTHER INFORMATION HAVE BEEN MADE. ALLERGAN HAS RECEIVED NO RESPONSE FROM THE AUTHORS. INFECTION IS A SURGICAL/PHYSIOLOGICAL COMPLICATION AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THIS EVENT. DEVICE LABELING ADDRESSES THE REPORTED EVENT OF INFECTION AS FOLLOWS: 3. INFECTION. PRE-EXISTING INFECTIONS NOT RESOLVED BEFORE TISSUE EXPANDER PLACEMENT MAY INCREASE THE RISK OF PERIPROSTHETIC INFECTION. INFECTION IS AN INHERENT RISK FOLLOWING ANY TYPE OF INVASIVE SURGERY, AND MAY OCCUR DURING THE TISSUE EXPANSION PROCESS. PTS WHO PRESENT WITH WOUND DEHISCENCE, TISSUE EROSION, ISCHEMIA OR NECROSIS, AND PTS UNDERGOING IMMEDIATE BREAST RECONSTRUCTION RUN AN INCREASED RISK OF PERIPROSTHETIC INFECTION. SIGNS OF ACUTE INFECTION REPORTED IN ASSOCIATION WITH TISSUE EXPANDERS INCLUDE ERYTHEMA, TENDERNESS, FLUID ACCUMULATION, PAIN AND FEVER. ERYTHEMA MAY ALSO OCCUR AS A NORMAL RESPONSE TO EXPANSION. ASPIRATION TO DIFFERENTIATE BETWEEN THIS TYPE OF ERYTHEMA AND ERYTHEMA AS A SIGN OF EARLY INFECTION IS A RECOGNIZED PRECAUTION. RESEARCH IDENTIFIES STAPHYLOCOCCUS AND PSEUDOMONAS ORGANISMS IN ASSOCIATION WITH INFECTION AROUND TISSUE EXPANDERS. ESCHERICHIA AND STREPTOCOCCUS ORGANISMS HAVE ALSO BEEN NOTED IN ASSOCIATION WITH TISSUE EXPANDERS IN THE LOWER EXTREMITIES. INFECTION MAY OCCUR AT ANY TIME AFTER SURGERY, AND MAY COMPROMISE THE EXPANSION PROCESS. CAPSULAR CONTRACTURE MAY BE RELATED TO INFECTION IN THE AREA SURROUNDING THE IMPLANT. POSTOPERATIVE INFECTIONS SHOULD BE TREATED AGGRESSIVELY ACCORDING TO STANDARD MEDICAL PRACTICES TO AVOID MORE SERIOUS COMPLICATIONS. INFECTION THAT IS UNRESPONSIVE TO TREATMENT OR NECROTIZING INFECTION MAY REQUIRE PREMATURE BREAST TISSUE EXPANDER REMOVAL. IN RARE INSTANCES, ACUTE INFECTION MAY OCCUR IN A BREAST WITHOUT IMPLANTS. THE SIGNS OF ACUTE INFECTION INCLUDE ERYTHEMA, TENDERNESS, FLUID ACCUMULATION, PAIN AND FEVER. VERY RARELY, TOXIC SHOCK SYNDROME, A POTENTIALLY LIFE-THREATENING CONDITION, HAS BEEN REPORTED IN WOMEN AFTER BREAST IMPLANT SURGERY. IT IS CHARACTERIZED BY SYMPTOMS THAT OCCUR SUDDENLY AND INCLUDE HIGH FEVER (102 DEGREES F, 38.8 DEGREES C OR HIGHER), VOMITING, DIARRHEA, A SUNBURN-LIKE RASH, RED EYES, DIZZINESS, LIGHTHEADEDNESS, MUSCLE ACHES, AND DROPS IN BLOOD PRESSURE, WHICH MAY CAUSE FAINTING. PTS SHOULD BE ADVISED TO CONTACT A PHYSICIAN IMMEDIATELY FOR DIAGNOSIS AND TREATMENT FOR ANY OF THESE SYMPTOMS.

    Description of Event or Problem · 1

    DOCTOR REPORTED EVENTS OF "FOUR INFECTIOUS COMPLICATIONS WITH (B)(6) FOLLOWING THE INSERTION OF EXPANDERS." (B)(4). ALTHOUGH THE MFR OF THE DEVICE IS UNK, IT IS ALLERGAN'S APPROACH TO COMPLIANCE TO RESOLVE ALL DOUBT IN FAVOR OF REPORTING. THIS MW IS FOR THE LEFT SIDE. REFER TO MFR REPORT 2024601-2013-00396 FOR THE LEFT SIDE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    219123 UNK TISSUE EXPANDER LCJ ALLERGAN NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Required Intervention