BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MESH C-QUR V-PATCH

    MDR report key: 11687519 · Received April 19, 2021

    Report

    Report Number
    3011175548-2021-00417
    Event Type
    Injury
    Date Received
    April 19, 2021
    Date of Event
    October 20, 2018
    Report Date
    August 20, 2021
    Manufacturer
    ATRIUM MEDICAL CORPORATION
    Product Code
    FTL
    UDI-DI
    00650862312003
    PMA / PMN Number
    K090909
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: BASED ON THE DETAILS OF THE COMPLAINT THE PATIENT HAD A C-QUR V-PATCH MESH IMPLANTED IN (B)(6) 2018 COMPLAINED THAT SHE HAS HAD SWELLING IN THE IMPLANT AREA, FATIGUE, PAIN AND NAUSEA POST IMPLANTATION. THE IMPLANTING DOCTOR IN 2019 WAS DR (B)(6) SUGGESTED IT MAY BE AN ALLERGIC REACTION TO THE STAPLES, AND HER LATEST DOCTOR, YURI NOVITSKY, COLUMBIA HOSPITAL NY RECOMMENDED SHE FIND OUT WHAT THE MATERIAL OF THE V-PATCH IS MADE FROM AS SHE MAY BE HAVING AN ALLERGIC REACTION TO IT. ATRIUM MEDICAL DOES NOT KNOW OR HAVE THE ABILITY TO DETERMINE IF THE PATIENT IS OR WAS ALLERGIC TO THE HERNIA MESH. THE DETAILS PROVIDED ALSO INDICATE THAT PRIOR TO THE IMPLANTATION OF THE C-QUR MESH IN (B)(6) 2018 THE PATIENT HAD A PROCEDURE FOR "PERFORATED DIVERTICULITIS AND A FISTULA FOLLOWED BY A SECONDARY PROCEDURE IN (B)(6) 2018 FOR A SMALL BOWEL RESECTION. THE DESCRIPTION OF THE HERNIA MESH IS AS FOLLOWS AS DESCRIBED IN THE INSTRUCTIONS FOR USE (IFU): C-QUR V-PATCH MESH IS A STERILE, KNITTED POLYPROPYLENE MONOFILAMENT MESH MATERIAL WITH A BIO-ABSORBABLE, ANIMAL DERIVED OIL COATING (O3FA) COMPOSED OF FATTY ACIDS, LIPIDS AND GLYCERIDES. THE C-QUR V-PATCH MESH IS CONSTRUCTED OF 2 LAYERS (1 LAYER OF C-QUR FX MESH, 1 LAYER OF C-QUR MESH) THAT ARE SEWN TOGETHER AROUND A BIO-ABSORBABLE COATED MESH STABILIZING RING TO FORM A REINFORCED MESH BASE, WITH 2 EXTENDED MESH STRAPS FOR DEVICE POSITIONING, SUTURE FIXATION AND HANDLING OUTSIDE OF THE ABDOMINAL WALL THAT IS CONSTRUCTED OF POLYPROPYLENE MONOFILAMENT. PER THE (IFU) ADVERSE REACTIONS, SECTION STATES THE FOLLOWING: COMPLICATIONS THAT MAY OCCUR WITH THE USE OF ANY SURGICAL MESH INCLUDE, BUT ARE NOT LIMITED TO PAIN, INFLAMMATION, INFECTION, ALLERGIC REACTION, SEROMA, HEMATOMA, FISTULA FORMATION OR MECHANICAL DISRUPTION OF THE TISSUE AND/OR MESH MATERIAL AND POSSIBLY ADHESIONS WHEN PLACED IN DIRECT CONTACT WITH THE VISCERA AND OTHER ORGANS. THE PATIENT SHOULD BE ADVISED TO CONTACT THE PHYSICIAN SHOULD AN ADVERSE REACTION OCCUR. ALSO MENTIONED IN THE IFU IN THE WARNINGS SECTION LINE ITEM 5 "ADEQUATE MESH FIXATION IS REQUIRED TO MINIMIZE POST-OPERATIVE COMPLICATIONS AND RECURRENCE. THE FIXATION TECHNIQUE, METHOD AND PRODUCTS USED (INCLUDING SUTURES, TACKS, STAPLES OR OTHER MEANS) IS LEFT TO THE DISCRETION OF THE SURGEON TO OPTIMIZE CLINICAL OUTCOMES." BASED ON THE DETAILS OF THE REPORTED EVENT THE COMPLAINT CANNOT BE CONFIRMED. THERE IS NO EVIDENCE THAT THE C-QUR V-PATCH MESH WAS THE CAUSE OF THE ADVERSE EFFECTS NOTED BY THE PATIENT. H3 OTHER TEXT: DEVICE NOT AVAILABLE FOR RETURN.

    Description of Event or Problem · 0

    N/A.

    Additional Manufacturer Narrative · 1

    UPON COMPLETION OF THE INVESTIGATION INTO THIS EVENT A FOLLOW UP REPORT WILL BE SUBMITTED. DEVICE EVALUATED BY MANUFACTURER? NOT RETURNED.

    Description of Event or Problem · 1

    HOME PATIENT HAVING ISSUES IN TERMS OF PAIN UPON DISCHARGE FROM HOSPITAL, SWELLING IN THE AREA AND FATIGUE, TIREDNESS, NAUSEA AND DISCOMFORT ALL THE TIME AFTER HER MESH IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    584642 MESH C-QUR V-PATCH MESH, SURGICAL, POLYMERIC FTL ATRIUM MEDICAL CORPORATION 31200 00650862312003

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention