BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CALDERA DESARA BLUE MUS

    MDR report key: 20724234 · Received November 18, 2024

    Report

    Report Number
    MW5162638
    Event Type
    Injury
    Date Received
    November 18, 2024
    Date of Event
    June 6, 2023
    Report Date
    November 14, 2024
    Manufacturer
    CALDERA MEDICAL, INC.
    Product Code
    PWJ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WA, US
    Reporter Occupation
    UNKNOWN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    PT HISTORY OF RENAL CONGENITAL DEFECTS. TOLD MUS WAS SAFE AND GOLD STANDARD. SURGEON RECOMMENDED MUS AFTER POP REPAIR, STATING URETHRA WAS "KINKED" AND WOULD NEED SUPPORT AFTER POP (PELVIC ORGAN PROLAPSE) REPAIR. PT HAD THIN VAG TISSUES. SURGEON PLACED MUS A LITTLE DIFFERENTLY (PER SURGEON). PT COMPLAINED IN POST-OP RECOVERY OF UNUSUAL SEVERE PAIN, SWELLING, CLOTS, BLEEDING, AND SEVERE URETHRAL SWELLING. PT DISMISSED AND TOLD ALL NORMAL. PT REPORTED SEVERE TISSUE AND NERVE PAIN, CLINICAL SWELLING, MESH PALPABLE W/ INTERNAL EXAM, INABILITY TO SIT, FOR MONTHS FOLLOWING MUS AND POP SX. PT ADVOCATED FOR HELP COMPLAINING OF CONT. POST SURGICAL PAIN, INABILITY TO SIT, URETHRAL/CLITORAL PAIN. PT DISMISSED. PT OUTSOURCED TO ANOTHER STATE FOR MEDICAL CARE, AND TO HAVE MESH REMOVED. PT ALLERGIC TO MESH AND HAD DX MESH COMPLICATIONS. PT SUFFERED SEVERE PAIN, SWELLING, HYPERPLASIA, NERVE PAIN, CLINICAL SWELLING AND REDNESS. PT DEVELOPED SEVERE INTERNAL BLEEDING DURING MESH REMOVAL SX. PT NEEDED RE-HOSPITALIZATION FOR BLOOD TRANSFUSION FROM MESH REMOVAL. PT SUFFERS WITH SCAR TISSUE AND ADHESIONS FROM MESH AND MESH REMOVAL. PT UNABLE TO HAVE SEX. PT NEEDING CONT. PFPT (PELVIC FLOOR PHYSICAL THERAPY) AND MEDICAL CARE FOR INJURIES RELATED TO MESH COMPLICATIONS. TOO MANY WOMEN ARE DISMISSED AND TREATED DISRESPECTFULLY WHEN RETURNING BACK TO THEIR MEDICAL PROVIDERS COMPLAINING OF PAIN AFTER MUS SX. THIS IS NOT ACCEPTABLE. THESE REACTIONS, REPORTED SYMPTOMS, AND CLINICAL SYMPTOMS NEED TO BE TAKEN SERIOUSLY. THIS HAD ADVERSELY AFFECTED MY BODY AND MY LIFE, WITH LOSS OF MY SEXUAL FUNCTION, WITH CONT. DAILY PAIN. FIBRIN (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2008409 CALDERA DESARA BLUE MUS INSTRUMENTATION, SURGICAL MESH, UROGYNECOLOGIC, STRESS URINARY INCONTINENCE PWJ CALDERA MEDICAL, INC. CALDS01BTV30

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Female Required Intervention| H| S