BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MOTIVA FLORA TISSUE EXPANDER

    MDR report key: 18907889 · Received March 14, 2024

    Report

    Report Number
    3012883202-2024-03638
    Event Type
    Injury
    Date Received
    March 14, 2024
    Date of Event
    October 30, 2023
    Report Date
    March 26, 2024
    Manufacturer
    MOTIVA USA LLC
    Product Code
    LCJ
    PMA / PMN Number
    K211676
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    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. ADDITIONALLY, NO OTHER ADVERSE OUTCOME REGARDING THE PATIENT HAS BEEN REPORTED. 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: "INFECTION: INFECTION CAN OCCUR WITH ANY SURGERY OR IMPLANTED DEVICE. MOST INFECTIONS RESULTING FROM SURGERY APPEAR WITHIN A FEW DAYS TO WEEKS AFTER THE OPERATION. HOWEVER, INFECTION IS POSSIBLE AT ANY TIME AFTER SURGERY. INFECTIONS IN TISSUE WITH AN EXPANDER PRESENT ARE HARDER TO TREAT THAN INFECTIONS IN TISSUE WITHOUT ANY. IF AN INFECTION DOES NOT RESPOND TO ANTIBIOTICS, THE EXPANDER MAY HAVE TO BE REMOVED AND ANOTHER DEVICE MAY BE PLACED AFTER THE INFECTION IS RESOLVED. AS WITH OTHER SURGICAL PROCEDURES, TOXIC SHOCK SYNDROME IN RARE INSTANCES HAS BEEN NOTED IN WOMEN AFTER BREAST IMPLANT SURGERY. THIS IS A LIFE-THREATENING CONDITION AND ITS SYMPTOMS INCLUDE: SUDDEN FEVER, VOMITING, DIARRHEA, FAINTING, DIZZINESS, AND/OR SUNBURN-LIKE RASH. PATIENTS SHOULD BE INSTRUCTED TO CONTACT THEIR DOCTOR IMMEDIATELY FOR DIAGNOSIS AND TREATMENT IF THEY HAVE THESE SYMPTOMS." 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. ANY OTHER APPLICABLE FINDINGS WILL BE INCLUDED IN A SUPPLEMENTAL MEDWATCH.

    Additional Manufacturer Narrative · 0

    THE SPECIFIC PATIENT DEMOGRAPHICS SUCH AS AGE, WEIGH, ETHNICUTY, ETC HAS NOT BEEN PROVIDED BY THE REPORTER. ADDITIONALLY, NO OTHER ADVERSE OUTCOME REGARDING THE PATIENT HAS BEEN REPORTED. INFECTION IS A KNOW RISK OF IMPLANTATION WITH TISSUE EXPANDERS AND IT IS DOCUMENTED IN THE MOTIVA FLORA TISSUE EXPANDER DIRECTIONS FOR USE (B)(4), REVISION 6),AS FOLLOWS: "INFECTION: INFECTION CAN OCCUR WITH ANY SURGERY OR IMPLANTED DEVICE. MOST INFECTIONS RESULTING FROM SURGERY APPEAR WITHIN A FEW DAYS TO WEEKS AFTER THE OPERATION. HOWEVER, INFECTION IS POSSIBLE AT ANY TIME AFTER SURGERY. INFECTIONS IN TISSUE WITH AN EXPANDER PRESENT ARE HARDER TO TREAT THAN INFECTIONS IN TISSUE WITHOUT ANY. IF AN INFECTION DOES NOT RESPOND TO ANTIBIOTICS, THE EXPANDER MAY HAVE TO BE REMOVED AND ANOTHER DEVICE MAY BE PLACED AFTER THE INFECTION IS RESOLVED. AS WITH OTHER SURGICAL PROCEDURES, TOXIC SHOCK SYNDROME IN RARE INSTANCES HAS BEEN NOTED IN WOMEN AFTER BREAST IMPLANT SURGERY. THIS IS A LIFE-THREATENING CONDITION AND ITS SYMPTOMS INCLUDE: SUDDEN FEVER, VOMITING, DIARRHEA, FAINTING, DIZZINESS, AND/OR SUNBURN-LIKE RASH. PATIENTS SHOULD BE INSTRUCTED TO CONTACT THEIR DOCTOR IMMEDIATELY FOR DIAGNOSIS AND TREATMENT IF THEY HAVE THESE SYMPTOMS." 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 CONTIBUTED TO THIS INCIDENT. AFTER ANALYZING THE EVIDENCE RECEIVED, THE ALLEGED INFECTION WAS NOT CONFIRMED DUE TO A LACK OF CLINICAL EVIDENCE.

    Description of Event or Problem · 0

    SURGEON REPORTED THAT THE MOTIVA FLORA TISSUE EXPANDER WAS EXPLANTED BEFORE THE SCHEDULED TIME DUE TO INFECTION. AT THE TIME OF THIS REPORT, THERE WAS NO ADDITIONAL INFORMATION AVAILABLE REGARDING THE PATIENT'S CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    169582 MOTIVA FLORA TISSUE EXPANDER MOTIVA FLORA TISSUE EXPANDER LCJ MOTIVA USA LLC 23010017

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other