BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARD SOFT MESH

    MDR report key: 23958389 · Received January 5, 2026

    Report

    Report Number
    1213643-2025-01308
    Event Type
    Malfunction
    Date Received
    January 5, 2026
    Date of Event
    December 1, 2021
    Report Date
    December 22, 2025
    Manufacturer
    DAVOL INC., SUB. C.R. BARD, INC. -1213643
    Product Code
    FTL
    PMA / PMN Number
    K052155
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EG
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE CONTENTS OF THE ARTICLE, NO CONCLUSIONS CAN BE MADE. THE INFORMATION IS LIMITED TO THE CONTENT OF THE ARTICLE. THE ARTICLE DOES NOT REPORT THAT ANY SPECIFIC DEVICE MALFUNCTION OR ALLEGED POST-OP COMPLICATION WAS CAUSED OR CONTRIBUTED TO THE USE OF THE BARD SOFT MESH USED TO TREAT THE PATIENTS. NO LOT NUMBER HAS BEEN PROVIDED; THEREFORE, A REVIEW OF THE MANUFACTURING RECORDS IS NOT POSSIBLE. SEROMA FORMATION, INFECTION AND HEMATOMA ARE CLINICALLY UNDERSTOOD POTENTIAL COMPLICATIONS OF SURGERY/USE OF THE DEVICE AND ARE IDENTIFIED IN THE INSTRUCTIONS-FOR-USE PROVIDED WITH THE DEVICE, AS POSSIBLE COMPLICATIONS. ADDITIONALLY, THE WARNINGS SECTION STATES "IF AN INFECTION DEVELOPS, TREAT THE INFECTION AGGRESSIVELY. CONSIDERATION SHOULD BE GIVEN REGARDING THE NEED TO REMOVE THE MESH. AN UNRESOLVED INFECTION MAY REQUIRE REMOVAL OF THE MESH". NOTE, THE DATE OF EVENT (01-DEC-2021) IS CONSIDERED TO BE A BEST ESTIMATE. THIS MDR REPRESENTS THE BARD SOFT MESH. ADDITIONAL MDR'S WERE SUBMITTED TO REPRESENT THE VENTRALIGHT ST MESH AND 3DMAX MESH. NOTE: SECTION A THROUGH F - THE INFORMATION PROVIDED BY BD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BD.

    Description of Event or Problem · 0

    PER JOURNAL ARTICLE: "QUALITY OF LIFE AFTER LAPAROSCOPIC REPAIR AND OPEN TENSION-FREE MESH REPAIR OF INGUINAL HERNIA" GROIN HERNIA REPAIR IS ONE OF THE MOST COMMON SURGICAL PROCEDURES WORLDWIDE. THIS PROSPECTIVE STUDY COMPARED OUTCOMES AND QUALITY OF LIFE (QOL) BETWEEN LAPAROSCOPIC REPAIR (TAPP) AND OPEN TENSION-FREE MESH REPAIR (LICHTENSTEIN TECHNIQUE) FOR UNILATERAL INGUINAL HERNIA. THE FOCUS WAS ON OPERATIVE PARAMETERS, POSTOPERATIVE COMPLICATIONS, AND QOL ASSESSMENT USING THE RAND SF-36 QUESTIONNAIRE. BARD® MESHES WERE USED IN BOTH TECHNIQUES. THE STUDY INCLUDED 100 ADULT PATIENTS WITH UNILATERAL INGUINAL HERNIA OPERATED BETWEEN DECEMBER 2021 AND SEPTEMBER 2022 AT (B)(6) HOSPITALS. PATIENTS WERE DIVIDED INTO TWO GROUPS: GROUP A: 50 PATIENTS UNDERWENT LAPAROSCOPIC REPAIR. GROUP B: 50 PATIENTS UNDERWENT OPEN TENSION-FREE MESH REPAIR. EXCLUSION CRITERIA INCLUDED MORBID OBESITY, PREVIOUS PELVIC SURGERY, COMPLICATED OR GIANT HERNIAS, AND PATIENTS UNFIT FOR SURGERY. OPEN REPAIR UTILIZED THE LICHTENSTEIN TECHNIQUE WITH BARD SOFT MESH (6×11 CM) IN ALL CASES, WITH MESH PLUG INSERTION IN 6 PATIENTS FOR WIDE INTERNAL RINGS. LAPAROSCOPIC REPAIR USED BARD SOFT MESH (6×11 CM) IN 25 PATIENTS, VENTRALIGHT ST MESH (4×11 CM) IN 20 PATIENTS, AND BARD 3D MAX MESH (4×6 CM) IN 5 PATIENTS. BOTH GROUPS RECEIVED STANDARD PREOPERATIVE PREPARATION, PROPHYLACTIC ANTIBIOTICS, AND POSTOPERATIVE CARE. QOL WAS ASSESSED POSTOPERATIVELY USING THE SF-36 QUESTIONNAIRE. POSTOPERATIVE COMPLICATIONS WERE GENERALLY MINOR AND RESOLVED WITHOUT SURGICAL INTERVENTION. IN THE OPEN REPAIR GROUP: SEROMA OCCURRED IN 4 PATIENTS, WOUND INFECTION IN 2, HEMATOMA IN 3, SCROTAL EDEMA IN 6, AND URINARY RETENTION IN 4. IN THE LAPAROSCOPIC GROUP, SEROMA OCCURRED IN 2 PATIENTS, SUBCUTANEOUS EMPHYSEMA IN 3, HEMATOMA IN 2, SCROTAL EDEMA IN 4, AND URINARY RETENTION IN 2. NO WOUND INFECTIONS WERE REPORTED IN THE LAPAROSCOPIC GROUP. ARTICLE MENTIONS ON NO DRAINS WERE EMPLOYED IN EITHER THE OPEN OR LAPAROSCOPIC OPERATIONS. NO RECURRENCES WERE OBSERVED IN EITHER GROUP DURING THE FOLLOW-UP PERIOD AND POSTOPERATIVE PROBLEMS WERE SELF-RESOLVING AND SUBSIDED SPONTANEOUSLY WITHOUT NECESSITATING SURGICAL INTERVENTION. NOTE: THERE IS NO INFORMATION PROVIDED IN THE ARTICLE INDICATING THAT THE DEVICE CAUSED OR CONTRIBUTED TO THE POSTOPERATIVE PATIENT COMPLICATION(S). HOWEVER, AS POSTOPERATIVE COMPLICATIONS DID PRESENT AND MAY REQUIRE MEDICAL/SURGICAL INTERVENTION WE ARE REPORTING THIS TO THE FDA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    27400 BARD SOFT MESH SURGICAL MESH FTL DAVOL INC., SUB. C.R. BARD, INC. -1213643 NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention