BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PVP MEDIUM 6.4CM X 6.4CM

    MDR report key: 19164748 · Received April 23, 2024

    Report

    Report Number
    2210968-2024-04798
    Event Type
    Injury
    Date Received
    April 23, 2024
    Date of Event
    March 24, 2024
    Manufacturer
    ETHICON INC.
    Product Code
    FTL
    UDI-DI
    10705031132405
    PMA / PMN Number
    K061533
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY ETHICON INC, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON INC, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: PLEASE PROVIDE THE PATIENT'S DEMOGRAPHIC INFORMATION INCLUDING AGE, GENDER, WEIGHT, BMI AT THE TIME OF INDEX PROCEDURE. AGE 28, FEMALE, 64KG, BMI 25. NAME OF INDEX SURGICAL PROCEDURE? OPEN UMBILICAL HERNIOPLASTY WITH PREPERITONEAL MESH. THE DIAGNOSIS AND INDICATION FOR THE INDEX SURGICAL PROCEDURE? UMBILICAL HERNIA. WERE ANY CONCOMITANT PROCEDURES PERFORMED? NO. WHAT WAS THE INITIAL APPROACH FOR THE INDEX SURGICAL PROCEDURE? OPEN. WERE ANY CONCURRENT DEVICES IMPLANTED? NO. WERE THERE ANY INTRA-OPERATIVE COMPLICATIONS? NO. OTHER RELEVANT PATIENT HISTORY/CONCOMITANT MEDICATIONS? NONE. PLEASE PROVIDE THE ONSET DATE/TIME OF PAIN FROM THE INITIAL PROCEDURE (# OF POST-OPERATIVE DAYS). FIRST POSTOPERATIVE DAY. PLEASE DESCRIBE ANY MEDICAL INTERVENTION GIVEN FOR PAIN MANAGEMENT INCLUDING MEDICATION NAME AND RESULTS. PARACETAMOL 1G X 3 P.O. IBUPROFEN 600MG X 3 P.O. OXYCODONE/NALOXONE 5MG/2,5MG X 2 P.O. SEVERAL DOSES OF OXYCODONE 4-6MG I.V. AND I.M. DURING ER VISITS. DESCRIBE THE SURGICAL INTERVENTION INCLUDING DATES AND FINDINGS. INDICATION FOR REOPERATION WAS SEVERE/DEBILITATING POSTOPERATIVE PAIN. THE SKIN, SUBCUTANEOUS TISSUE AND FASCIA WERE NORMAL, FASCIAL SUTURES WERE REMOVED AND SEROUS SLIGHTLY CLOUDY LIQUID WAS FOUND ENVELOPING THE MESH IN THE PREPERITONEAL SPACE. THE MESH APPEARED TO BE FRAGMENTED INTO VERY RIGID AND SHARP-EDGED FRAGMENTS. ALL MESH PARTS WERE REMOVED, THE FASCIA WAS SUTURED AND THE WOD WAS LEFT OPEN. WAS THE MESH FULLY OR PARTIALLY EXCISED? FULLY EXCISED. CAN YOU CONFIRM THAT THE FRAGMENTS WERE REMOVED? YES. WHAT IS THE PHYSICIAN¿S OPINION AS TO THE ETIOLOGY OF OR CONTRIBUTING FACTORS TO THIS EVENT? NO OPINION. WHAT IS THE PATIENT'S CURRENT STATUS? STILL PAINFUL BUT BETTER THAN PREOP. WOUND HAS BEEN SECONDARILY CLOSED. NO SIGN OF INFECTION. CULTURES NEGATIVE. PRODUCT LOT NUMBER? UNAVAILABLE BECAUSE INDEX PROCEDURE WAS PERFORMED AT A PRIVATE CLINIC. ARE THERE ANY PHOTOS AVAILABLE? NO.

    Additional Manufacturer Narrative · 0

    (B)(4). THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY ETHICON INC, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON INC, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. ATTEMPTS ARE BEING MADE TO OBTAIN THE FOLLOWING INFORMATION. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. PLEASE PROVIDE THE PATIENT'S DEMOGRAPHIC INFORMATION INCLUDING AGE, GENDER, WEIGHT, BMI AT THE TIME OF INDEX PROCEDURE NAME OF INDEX SURGICAL PROCEDURE? THE DIAGNOSIS AND INDICATION FOR THE INDEX SURGICAL PROCEDURE? WERE ANY CONCOMITANT PROCEDURES PERFORMED? WHAT WAS THE INITIAL APPROACH FOR THE INDEX SURGICAL PROCEDURE? WERE ANY CONCURRENT DEVICES IMPLANTED? WERE THERE ANY INTRA-OPERATIVE COMPLICATIONS? OTHER RELEVANT PATIENT HISTORY/CONCOMITANT MEDICATIONS? PLEASE PROVIDE THE ONSET DATE/TIME OF PAIN FROM THE INITIAL PROCEDURE (# OF POST-OPERATIVE DAYS). PLEASE DESCRIBE ANY MEDICAL INTERVENTION GIVEN FOR PAIN MANAGEMENT INCLUDING MEDICATION NAME AND RESULTS. DESCRIBE THE SURGICAL INTERVENTION INCLUDING DATES AND FINDINGS. WAS THE MESH FULLY OR PARTIALLY EXCISED? CAN YOU CONFIRM THAT THE FRAGMENTS WERE REMOVED? WHAT IS THE PHYSICIAN¿S OPINION AS TO THE ETIOLOGY OF OR CONTRIBUTING FACTORS TO THIS EVENT? WHAT IS THE PATIENT'S CURRENT STATUS? PRODUCT LOT NUMBER? ARE THERE ANY PHOTOS AVAILABLE? TO DATE THE DEVICE HAS NOT BEEN RETURNED. IF THE DEVICE OR FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. H6 COMPONENT CODE: G07002 ¿ DEVICE NOT RETURNED.

    Additional Manufacturer Narrative · 0

    (B)(4). THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY ETHICON INC, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON INC, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. H3 ANALYSIS SUMMARY: THE PRODUCT WAS RETURNED TO ETHICON FOR EVALUATION. THE RETURNED SAMPLE REVEALED THAT IT WAS RECEIVED ONE MESH IN USE CONDITION THAT PERTAIN TO PRODUCT CODE PVPM. DURING VISUAL INSPECTION OF THE SAMPLE, IT WAS NOTED THAT THE DEGRADATION PROCESS HAS BEGUN ON THE TOP ASSEMBLY AND BOTTOM. ALSO, THE FRACTURED RING WAS FOUND. BODY FLUIDS AND DETACHED STRAPS WERE NOTED TOO IN THE SAMPLE; THIS IS CONSISTENT WITH THE REMOVAL OF THE PRODUCT FROM THE PATIENT. AS PART OF THE ETHICON QUALITY PROCESS ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. PER THE CONDITIONS OF THE RETURNED SAMPLE, NO CONCLUSION COULD BE REACHED ON THE CAUSE OF THE REPORTED EVENT, THE INSTRUCTIONS FOR USE CONTAIN THE FOLLOWING CAUTION: PROCEED VENTRAL PATCH (PVP) IS INTENDED FOR THE REPAIR OF HERNIAS OR OTHER ABDOMINAL FASCIAL DEFECTS THAT REQUIRE THE ADDITION OF A REINFORCING OR BRIDGING MATERIAL TO OBTAIN THE DESIRED SURGICAL RESULT. ADDITIONAL COMPLAINT INFORMATION MONITORING FOR POTENTIAL SAFETY SIGNALS IS CONDUCTED THROUGH COMPLAINT TRENDING AS PART OF POST-MARKET SURVEILLANCE. THE MANUFACTURING RECORDS COULD NOT BE REVIEWED AS THE BATCH/LOT NUMBER IS UNKNOWN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024 AND MESH WAS IMPLANTED. AFTER SURGERY, THE PATIENT HAS HAD SEVERE PAIN IN THE ABDOMEN AREA. THE MESH PATCH WAS TAKEN OFF ON (B)(6) 2024. FROM THE ABDOMINAL CAVITY, THE SURGEON FOUND HARD ALMOST PLASTIC LIKE PIECES WHICH WERE FRAGMENTS OF THE MESH EDGES. THE CUSTOMER IS SURE THAT THE FRAGMENTS ARE FROM THE MESH, WHEN THEY MATCHED THE FRAGMENTS TO THE MESH WHICH WAS TAKEN OF FROM THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1070043 PVP MEDIUM 6.4CM X 6.4CM MESH, SURGICAL, POLYMERIC FTL ETHICON INC. 10705031132405

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Unknown Required Intervention