BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DESARA BLUE TVEZ 3.0 SYSTEM

    MDR report key: 23416527 · Received October 29, 2025

    Report

    Report Number
    3003990090-2025-01586
    Event Type
    Injury
    Date Received
    October 29, 2025
    Date of Event
    January 6, 2023
    Report Date
    October 29, 2025
    Manufacturer
    CALDERA MEDICAL INC.
    Product Code
    PWJ
    UDI-DI
    00890594000087
    PMA / PMN Number
    K211975
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION COULD NOT BE CONDUCTED THOROUGHLY BECAUSE THE DEVICE WAS NOT RETURNED. A REVIEW OF GENERAL MANUFACTURING RECORDS INDICATES THAT ALL PRODUCTS RELEASED DURING THE RELEVANT TIMEFRAME WERE MADE IN ACCORDANCE WITH APPROVED PROCEDURES AND MET THE ESTABLISHED SPECIFICATIONS DURING THE MANUFACTURING AND QUALITY RELEASE PROCESS. HOWEVER, ACCORDING TO THE COMPLAINT INFORMATION, THE PATIENT REPORTED AN ALLERGY TO MESH AND UNSUCCESSFUL SURGICAL PROCEDURES. AS A RESULT, THE CAUSE WAS ATTRIBUTED TO NON-DEVICE-RELATED FACTORS. BASED ON THE AVAILABLE INFORMATION, NO FURTHER ACTION IS REQUIRED AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS NECESSARY. THIS REPORT CONSIDER AS PART OF CAPA: CA25-512. THE MANUFACTURING NUMBER IS (B)(4)

    Description of Event or Problem · 0

    THE FDA (FOOD AND DRUG ADMINISTRATION) SENT A MEDICAL DEVICE REPORT UNDER MW5162638. 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
    216298 DESARA BLUE TVEZ 3.0 SYSTEM INSTRUMENTATION, SURGICAL MESH, UROGYNECOLOGIC, STRESS URINARY INCONTINENCE PWJ CALDERA MEDICAL INC. 00890594000087

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Female Hospitalization| R