BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PHASIX ST MESH

    MDR report key: 14958103 · Received July 7, 2022

    Report

    Report Number
    MW5110757
    Event Type
    Injury
    Date Received
    July 7, 2022
    Date of Event
    September 28, 2020
    Report Date
    July 6, 2022
    Manufacturer
    DAVOL INC.
    Product Code
    FTL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    IMPLANTED PHASIX ST MESH (HMHP DAVOL) (MODEL# 1202530) (LOT# HUDT1817), REVISION FOR A VENTRAL HERNIA REPAIR, DUE TO ALLERGIC REACTION FROM VENTRALIGHT ST MESH IMPLANT ON (B)(6)2018 (HMHP BARD DAVOL) (LOT# HUBX1087) (MODEL# 5954810). PAIN, THEN ANGIOEDEMA, MY ABDOMEN BECAME VERY SWOLLEN TWO MONTHS AFTER THEY PLACED THE PHASIX ST MESH. HAD MULTIPLE EMERGENCY ROOM VISIT. AFTER 2ND EMERGENCY ROOM VISIT, IT WAS CONCLUDED I WAS HAVING ALSO A REACTION TO THE PHASIX ST. ANTI-REACTIONS MEDICATIONS WERE GIVEN, HAD TO ACQUIRE A PLETHORA OF SPECIALIST (DOCTORS) TO CONTROL THE IMMUNOLOGICAL RESPONSE. ONGOING CURRENT THERAPY AND TREATMENTS. STILL HAVING PAIN, CURRENT TREATMENT IS HIGH DOSE OF ANTIHISTAMINE. THE MESH HAS NOT DISSOLVED, IT HAS PAST THE DISSOLVABLE PHASE. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1908276 PHASIX ST MESH MESH, SURGICAL, POLYMERIC FTL DAVOL INC. 1202530 HUDT1817

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Female Other OVER-THE-COUNTER MEDICATION: HIGH DOSE OF ANTIOXIDANT VITAMINS.| PRESCRIPTION MEDICATION: ALLEGRA.| PRESCRIPTION MEDICATION: ATARAX.| PRESCRIPTION MEDICATION: BENADRYL. | PRESCRIPTION MEDICATION: CROMOLYN.| PRESCRIPTION MEDICATION: INDOCINE.| PRESCRIPTION MEDICATION: ZYTEC.