BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UPRO HRN MSH 10CM U/LAY

    MDR report key: 23171980 · Received September 29, 2025

    Report

    Report Number
    2210968-2025-11156
    Event Type
    Injury
    Date Received
    September 29, 2025
    Date of Event
    July 4, 2025
    Manufacturer
    ETHICON INC.
    Product Code
    FTL
    PMA / PMN Number
    K071249
    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) 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 WERE ANY CONCOMITANT PROCEDURES PERFORMED? OTHER RELEVANT PATIENT HISTORY/CONCOMITANT MEDICATIONS? PLEASE DESCRIBE THE PATIENT MANIFESTATIONS OF THE REPORTED INFECTION (LOCATION, SEVERITY, APPEARANCE, SYSTEMIC OR LOCAL INFECTION). PLEASE PROVIDE THE ONSET DATE/TIME OF INFECTION FROM THE INITIAL SURGICAL PROCEDURE. WERE THERE ANY PRE-EXISTING SIGNS/SYMPTOMS OF ACTIVE INFECTION PRIOR TO THIS SURGICAL PROCEDURE? DID THE PATIENT RECEIVE ANY PROPHYLACTIC ANTIBIOTICS PRE-, INTRA- OR POST-OPERATION? WERE CULTURES PERFORMED? IF SO, PLEASE PROVIDE THE RESULTS. HOW MUCH AND WHAT TYPE OF DRAINAGE IS PRESENT IN THIS WOUND? PLEASE DESCRIBE ANY MEDICAL INTERVENTION PERFORMED INCLUDING MEDICATION NAME AND RESULTS. WHAT IS THE PHYSICIAN¿S OPINION AS TO THE ETIOLOGY OF OR CONTRIBUTING FACTORS TO THIS EVENT? WHAT IS THE PATIENT'S CURRENT STATUS? TO DATE IT HAS BEEN REPORTED THAT THE DEVICE WILL NOT BE 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. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO RELATED NON-CONFORMANCES WERE IDENTIFIED.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (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: H6. ADDITIONAL INFORMATION RECEIVED: THE PATIENT UNDERWENT RIGHT INGUINAL HERNIA TENSION-FREE REPAIR ON (B)(6) 2025 DUE TO "RIGHT INGUINAL HERNIA". THE SURGEON USED UHSL6 FOR TENSION-FREE HERNIA REPAIR OF THE HERNIA AND THE SURGERY WENT SMOOTHLY. ON (B)(6) 2025, THE PATIENT DEVELOPED INCISION PAIN, REDNESS AND SWELLING, WITH EXUDATION ACCOMPANIED BY LOW-GRADE FEVER (WITH SPECIFIC BODY TEMPERATURE UNKNOWN) AND WAS RE-ADMITTED TO THE HOSPITAL. ON THE DAY OF ADMISSION, AFTER DRAINAGE, THE PATIENT WAS GIVEN ANTIBIOTIC TREATMENT (WITH SPECIFIC MEDICATION NAME, DOSAGE AND TREATMENT CYCLE UNKNOWN). ON (B)(6) 2025, THE PATIENT'S INCISION PAIN AND REDNESS WERE SIGNIFICANTLY IMPROVED, WITH REDUCED EXUDATE AND STILL HAVING LOW-GRADE FEVER. THE SURGEON THEN REMOVED THE MESH IN (B)(6) 2025 (WITH SPECIFIC DATE UNKNOWN). THE PATIENT'S SYMPTOMS WERE IMPROVED SUBSEQUENTLY (WITH SPECIFIC IMPROVEMENT DATE UNKNOWN). THE PATIENT WAS DISCHARGED CURRENTLY, AND NO SUBSEQUENT ADVERSE EVENT REPORT WAS RECEIVED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT SURGERY FOR A RIGHT INGUINAL HERNIA ON (B)(6) 2025 AND MESH WAS IMPLANTED. ON THE 128TH DAY AFTER SURGERY, THE PATIENT EXPERIENCED PAIN, REDNESS, AND FLUID LEAKAGE AT THE SURGICAL INCISION. ON THE 138TH DAY AFTER SURGERY, THE PATIENT WAS ADMITTED FOR THE SECOND TIME. ON THE DAY OF ADMISSION, ANTIBIOTICS WERE USED AFTER DRAINAGE, AND NO PATCH WAS TAKEN OUT YET. ANTI INFECTION TREATMENT WAS GIVEN DAILY. ON THE 153RD DAY AFTER SURGERY, THE PATIENT'S RIGHT INGUINAL AREA IMPROVED SIGNIFICANTLY, WITH LESS WOUND EXUDATION AND STILL HAVING LOW-GRADE FEVER. THE PATIENT WAS DISCHARGED AND CONTINUED TREATMENT IN THE OUTPATIENT DEPARTMENT. IF NECESSARY, REMOVE THE PATCH. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1944033 UPRO HRN MSH 10CM U/LAY MESH, SURGICAL, POLYMERIC FTL ETHICON INC. UEBDHSB0

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention