BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE MESH 15X15CM

    MDR report key: 13005105 · Received December 14, 2021

    Report

    Report Number
    2210968-2021-12599
    Event Type
    Injury
    Date Received
    December 14, 2021
    Date of Event
    September 4, 2021
    Manufacturer
    ETHICON INC.
    Product Code
    FTL
    PMA / PMN Number
    K962530
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). DATE SENT TO THE FDA: 02/01/2022. 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, 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: THE PATIENT DEMOGRAPHIC INFO: WEIGHT, BMI AT THE TIME OF INDEX PROCEDURE WHAT ARE THE PATIENT COMORBIDITIES/CONCOMITANT MEDICATIONS? UNK. WAS ANY DEFICIENCY OR ANOMALY OF THE MESH? IF YES, PLEASE DESCRIBE IT. DOES THE PATIENT HAVE KNOWN ALLERGIC HISTORY TO MEDICAL DEVICE, FOOD OR MEDICATIONS?UNK. WAS THE DEVICE REMOVED? UNK. IF SO, PLEASE DATE AND DETAILS OF THE RE-OPERATION. NA. WHAT IS PHYSICIAN¿S OPINION AS TO THE ETIOLOGY OF OR CONTRIBUTING FACTORS TO THIS EVENT?UNK. WHAT IS THE PATIENT'S CURRENT STATUS? THE PATIENT RECOVERED WELL AND WAS DISCHARGED FROM THE HOSPITAL. NO FOLLOW-UP INJURY WAS REPORTED. HOW WAS THE MESH FIXATED? UNK. NO MORE INFORMATION CAN BE PROVIDED.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). DEVICE NOT RETURNED. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT, AND NO NON-CONFORMANCES WERE IDENTIFIED. 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. THE PATIENT DEMOGRAPHIC INFO: WEIGHT, BMI AT THE TIME OF INDEX PROCEDURE WHAT ARE THE PATIENT COMORBIDITIES/CONCOMITANT MEDICATIONS? WAS ANY DEFICIENCY OR ANOMALY OF THE MESH? IF YES, PLEASE DESCRIBE IT. DOES THE PATIENT HAVE KNOWN ALLERGIC HISTORY TO MEDICAL DEVICE, FOOD OR MEDICATIONS? WAS THE DEVICE REMOVED? IF SO, PLEASE DATE AND DETAILS OF THE RE-OPERATION. WHAT IS PHYSICIAN¿S OPINION AS TO THE ETIOLOGY OF OR CONTRIBUTING FACTORS TO THIS EVENT? WHAT IS THE PATIENT'S CURRENT STATUS? HOW WAS THE MESH FIXATED?

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT A TENSION-FREE HERNIORRHAPHY OF SULCUS HERNIA UNDER SPINAL ANESTHESIA ON (B)(6) 2021 AND THE MESH WAS IMPLANTED. IT WAS REPORTED THAT TEN DAYS AFTER THE SURGERY, THE PATIENT EXPERIENCED WOUND SECRETION. CONSIDERING THE REJECTION OF THE PATCH, RIGHT SCROTAL EDEMA REMOVAL WAS PERFORMED. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1895773 PROLENE MESH 15X15CM MESH, SURGICAL, POLYMERIC FTL ETHICON INC. PPBDKM

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Male Required Intervention