BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MOTIVA FLORA TISSUE EXPANDER

    MDR report key: 20033714 · Received August 22, 2024

    Report

    Report Number
    3012883202-2024-00031
    Event Type
    Injury
    Date Received
    August 22, 2024
    Date of Event
    October 3, 2022
    Report Date
    August 21, 2024
    Manufacturer
    MOTIVA USA LLC
    Product Code
    LCJ
    PMA / PMN Number
    K211676
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CI
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE SPECIFIC PATIENT DEMOGRAPHICS SUCH AS AGE, WEIGH, ETHNICITY, ETC HAS NOT BEEN PROVIDED BY THE REPORTER. TO DATE, MOTIVA FLORA TISSUE EXPANDER HAS NOT RECEIVED, THEREFORE AN ANALYSIS OF THE DEVICE COULD NOT BE COMPLETED. ADDITIONAL ATTEMPTS TO GET MORE INFORMATION ARE ONGOING AND THE INVESTIGATION IS IN PROCESS. INFECTION IS A KNOW RISK OF IMPLANTATION WITH TISSUE EXPANDERS AND IT IS DOCUMENTED IN THE MOTIVA FLORA TISSUE EXPANDER DIRECTIONS FOR USE (DOC-037, REVISION 6),AS FOLLOWS: "RISK OF A PERIPROSTHETIC INFECTION MAY BE INCREASED AS RESULT OF AN ACTIVE INFECTION. DO NOT EXPOSE THE TISSUE EXPANDER OR INJECTION NEEDLES TO CONTAMINANTS, WHICH INCREASE THE RISK OF INFECTION. PATIENTS WHO PRESENT WOUND DEHISCENCE, TISSUE EROSION, ISCHEMIA OR NECROSIS HAVE AN INCREASED RISK OF PERIPROSTHETIC INFECTION. DURING SURGERY, PROTECTIVE MEASURES MUST BE TAKEN TO AVOID POSSIBLE INFECTION OF THE AREA. INFECTIONS CAN COMPROMISE THE EXPANSION PROCESS, THEREFORE, ANY SYMPTOMS THAT OCCUR, SUCH AS TENDERNESS, FLUID ACCUMULATION, PAIN OR FEVER, MUST BE REPORTED TO THE SURGEON AS SOON AS POSSIBLE TO BE AGGRESSIVELY TREATED AND THUS AVOID SERIOUS COMPLICATIONS. PREMATURE TISSUE EXPANDER REMOVAL MAY BE REQUIRED IF THE INFECTION DOES NOT RESPOND TO TREATMENT, OR IN THE CASE OF A NECROTIZING INFECTION". IN ADDITION, A REVIEW OF THE DEVICE HISTORY RECORD WAS CONDUCTED, AND IT WAS CONCLUDED THAT THERE WERE NO DEVIATIONS IN THE MANUFACTURING PROCESS OF THIS DEVICE THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THIS INCIDENT. IF AND WHEN THE TISSUE EXPANDER IS RECEIVED AND THE ANALYSIS OF THE DEVICE HAS BEEN COMPLETED THE APPLICABLE FINDINGS WILL BE INCLUDED IN A SUPPLEMENTAL MEDWATCH.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ON 03-OCT-2022 THE PATIENT CONSULTED AFTER SUSTAINING A DIRECT BLOW TO THE RECONSTRUCTED LEFT BREAST. THIS INJURY LED TO DEHISCENCE AND PARTIAL EXPOSURE OF THE TISSUE EXPANDER. A DECISION WAS MADE TO DEFLATE THE EXPANDER AND RESUTURE THE AREA. TWO WEEKS LATER, SIGNS OF INFECTION DEVELOPED, AND THE PATIENT WAS TREATED WITH ANTIBIOTICS. HOWEVER, THE CONDITION DID NOT IMPROVE, AND ON (B)(6) 2022, AN EXPLANTATION SURGERY WAS PERFORMED. NO REPLACEMENT DEVICE, INCLUDING A FLORA TISSUE EXPANDER OR IMPLANT, WAS PLACED FOLLOWING THE EXPLANTATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    18761 MOTIVA FLORA TISSUE EXPANDER MOTIVA FLORA TISSUE EXPANDER LCJ MOTIVA USA LLC 19086127

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention