BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GALAFLEX

    MDR report key: 24896208 · Received April 16, 2026

    Report

    Report Number
    1213643-2026-00524
    Event Type
    Injury
    Date Received
    April 16, 2026
    Date of Event
    March 2, 2026
    Report Date
    April 8, 2026
    Manufacturer
    TEPHA, INC. - 3005670760
    Product Code
    OOD
    UDI-DI
    00855920006607
    PMA / PMN Number
    K140533
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    AS REPORTED, PATIENTS UNDERWENT PRE-PECTORAL BREAST RECONSTRUCTION WITH THE IMPLANT OF GALAFLEX. THE SURGEON MADE A GENERAL OBSERVATION STATING SOME PATIENTS PRESENTED POST IMPLANT WITH UNSATISFACTORY AESTHETIC OUTCOMES WITH INCREASED FIRMNESS, SKIN NECROSIS OR SKIN BREAKDOWN AND INFECTION. BASED ON THE INFORMATION REPORTED, NO CONCLUSIONS CAN BE MADE AS TO THE DEGREE TO WHICH THE IMPLANT MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENTS' POSTOPERATIVE COURSE. REVIEW OF MANUFACTURING RECORDS WAS NOT PERFORMED AS THE LOT NUMBER WAS NOT PROVIDED. INFECTION IS A KNOWN INHERENT RISK OF SURGERY AND IS INCLUDED AS A POSSIBLE COMPLICATION IN THE ADVERSE REACTION SECTION OF THE INSTRUCTIONS-FOR-USE (IFU) SUPPLIED WITH THE DEVICE. REGARDING INFECTION, THE WARNINGS SECTION OF THE IFU STATES: "IF AN INFECTION DEVELOPS, TREAT THE INFECTION AGGRESSIVELY. AN UNRESOLVED INFECTION MAY REQUIRE REMOVAL OF THE SCAFFOLD." NOTE: SECTION A THROUGH F - THE INFORMATION PROVIDED BY BD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT/REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BD.

    Description of Event or Problem · 0

    AS REPORTED, PATIENTS UNDERWENT PRE-PECTORAL BREAST RECONSTRUCTION WITH THE IMPLANT OF GALAFLEX. POST IMPLANT PATIENTS SHOWED UNSATISFACTORY AESTHETIC OUTCOMES WITH INCREASED FIRMNESS, SKIN NECROSIS OR SKIN BREAKDOWN AND INFECTION. REPORTEDLY, THE POST OPERATIVE COMPLICATIONS PERSISTED EVEN AFTER ONE YEAR OF IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    965676 GALAFLEX BREAST - ABSORBABLE MESH OOD TEPHA, INC. - 3005670760 100035-34 NI 00855920006607

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Other