BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VENTRALEX ST

    MDR report key: 8926889 · Received August 23, 2019

    Report

    Report Number
    1213643-2019-07507
    Event Type
    Injury
    Date Received
    August 23, 2019
    Report Date
    December 12, 2025
    Manufacturer
    DAVOL INC., SUB. C.R. BARD, INC. -1213643
    Product Code
    FTL
    UDI-DI
    00801741031489
    PMA / PMN Number
    K101928
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    AT THIS TIME NO CONCLUSIONS CAN BE MADE TO WHAT EXTENT THE BARD/DAVOL VENTRALEX ST(DEVICE #1) MAY HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THE CAUSE OF THE PATIENT POSTOPERATIVE COMPLICATIONS CANNOT BE DETERMINED AT THIS TIME. NO LOT NUMBER HAS BEEN PROVIDED THEREFORE A REVIEW OF THE MANUFACTURING RECORDS IS NOT POSSIBLE AT THIS TIME. ADDENDUM: THIS SUPPLEMENTAL EMDR IS SUBMITTED TO DOCUMENT ADDITIONAL INFORMATION PROVIDED. ROOT CAUSE IS INCONCLUSIVE, NO CONCLUSION CAN BE MADE AS TO THE EXTENT TO WHICH THE IMPLANT MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S POSTOPERATIVE COURSE. NOTE, THE MANUFACTURING DATE (15-JUL-2015) IS CONSIDERED TO BE A BEST ESTIMATE. UPDATED FIELDS: A2, A4, B4, B5, B6, B7, D4 (PRODUCT CATALOG NO., CORPORATE LOT NO., EXPIRY DATE, UDI NO.), G1, G3, G6, H2, H4, H6, H10. THIS SUPPLEMENTAL EMDR REPRESENTS THE BARD/DAVOL - VENTRALEX ST (DEVICE 2). ADDITIONAL SUPPLEMENTAL EMDR'S WERE SUBMITTED TO REPRESENT THE BARD/DAVOL - 3DMAX MESH (DEVICE 1), PERFIX PLUG (DEVICE 3), PERFIX PLUG (DEVICE 4) AND PERFIX PLUG (DEVICE 5). 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

    ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF AN UNSPECIFIED BARD/DAVOL VENTRALEX ST (DEVICE #1) AND UNSPECIFIED BARD/DAVOL 3DMAX (DEVICE #2) ON (B)(6) 2015. THE ATTORNEY ALSO ALLEGES THAT ON (B)(6) 2016, THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF TWO (2) UNSPECIFIED BARD/DAVOL PERFIX PLUG (DEVICE #3 AND DEVICE #4). ALSO, AS REPORTED, THE ATTORNEY ALLEGES ON (B)(6) 2017, THE PATIENT UNDERWENT SURGERY FOR AN UNSPECIFIED BARD/DAVOL PERFIX PLUG (DEVICE #5). AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE VENTRALEX ST (DEVICE #1), 3DMAX (DEVICE #2) AND THREE (3) PERFIX PLUGS (DEVICE #3, DEVICE #4 AND DEVICE #5). AS REPORTED, THE ATTORNEY ALLEGES GENERAL ALLEGATIONS FOR "PAST, PRESENT, AND FUTURE DAMAGES, INCLUDING BUT NOT LIMITED TO, MENTAL AND PHYSICAL PAIN AND SUFFERING FOR SEVERE AND PERMANENT PERSONAL INJURIES SUSTAINED BY THE PATIENT." ADDENDUM PER ADDITIONAL INFORMATION PROVIDED: (B)(6) 2015 - PATIENT WAS DIAGNOSED WITH LEFT INGUINAL HERNIA AND UPPER ABDOMINAL INCISIONAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC AND OPEN REPAIR WITH IMPLANT OF 3DMAX (DEVICE 1) AND VENTRALEX ST (DEVICE 2). PER OP NOTES, ¿A LARGE INDIRECT HERNIA WAS IDENTIFIED AND REDUCED. A 3DMAX (DEVICE 1) WAS PLACED IN THE PREPERITONEAL SPACE AND SECURED WITH TACKS TO COOPERS LIGAMENT. THE HERNIA SAC WAS IDENTIFIED AND FREED FROM SURROUNDING TISSUES. A VENTRALEX ST (DEVICE 2) WAS PLACED AND SECURED CIRCUMFERENTIALLY USING SUTURES.¿ (B)(6) 2016 - PATIENT WAS DIAGNOSED WITH RECURRENT INCARCERATED LEFT INGUINAL HERNIA WITH PAIN THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF PERFIX PLUG (DEVICE 3 AND 4). PER OP NOTES, ¿UPON OPENING THE SUPERFICIAL RING, A LARGE INCARCERATED INGUINAL HERNIA WITH PROTRUDING PERITONEAL FAT. THE HERNIA SAC WAS SEPARATED FROM SPERMATIC CORD AND OPENED. THE SAC ALSO CONTAINED SIGMOID COLON. ALL THE CONTENTS OF HERNIA WERE REDUCED. PERFIX PLUG (DEVICE 3 AND 4) WERE PLACED AND SECURED USING PROLENE SUTURES.¿ (B)(6) 2017 - PATIENT WAS DIAGNOSED WITH RECURRENT INCARCERATED LEFT INGUINAL HERNIA WITH PAIN THEREBY UNDERWENT OPEN REPAIR WITH PARTIAL EXCISION OF 3DMAX (DEVICE 1), PERFIX PLUGS (DEVICE 3 AND 4) AND IMPLANT OF PERFIX PLUG (DEVICE 5). PER OP NOTES, ¿SIGNIFICANT AMOUNT OF SCAR TISSUE WAS EXCISED. THERE WERE PRIOR MESHES (DEVICE 1,3 AND 4) FOLDED UP AND FOLDED PART OF MESH WAS EXCISED. SOME PIECES OF PRIOR MESH (DEVICE 1,3 AND 4) WERE DIFFICULT TO DISSECT FROM CORD STRUCTURES WHICH ARE PRESENT IN SITU. THE HERNIA SAC WAS IDENTIFIED, OPENED AND INCARCERATED COLON WAS REDUCED. A PERFIX PLUG (DEVICE 5) WAS PLACED AND TACKED.¿ (B)(6) 2018 - PATIENT WAS DIAGNOSED WITH RECURRENT LEFT INGUINAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH IMPLANT OF SYNTHETIC MESH. PER OP NOTES, ¿LARGE RECURRENT LEFT INGUINAL HERNIA WITH LARGE SCROTAL COMPONENT WERE REDUCED. THE FLOOR WAS VERY WEAK. THE FLOOR WAS RECONSTRUCTED WITH SYNTHETIC MESH AND SECURED WITH SUTURES. LEFT ORCHIECTOMY WAS PERFORMED.¿

    Additional Manufacturer Narrative · 1

    AT THIS TIME NO CONCLUSIONS CAN BE MADE TO WHAT EXTENT THE BARD / DAVOL VENTRALEX ST(DEVICE #1) MAY HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THE CAUSE OF THE PATIENT POSTOPERATIVE COMPLICATIONS CANNOT BE DETERMINED AT THIS TIME. NO LOT NUMBER HAS BEEN PROVIDED THEREFORE A REVIEW OF THE MANUFACTURING RECORDS IS NOT POSSIBLE AT THIS TIME. INFORMATION IS LIMITED. SHOULD ADDITIONAL INFORMATION BE PROVIDED A SUPPLEMENTAL EMDR WILL BE SUBMITTED. THIS EMDR REPRESENTS THE BARD/DAVOL VENTRALEX ST (DEVICE #1). ADDITIONAL MDRS WILL BE SUBMITTED TO FOR EACH OF THE OTHER BARD/DAVOL DEVICES WITH CLAIMS ALLEGED. NOT RETURNED.

    Description of Event or Problem · 1

    ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF AN UNSPECIFIED BARD / DAVOL VENTRALEX ST (DEVICE #1) AND UNSPECIFIED BARD/DAVOL 3DMAX (DEVICE #2) ON (B)(6) 2015. THE ATTORNEY ALSO ALLEGES THAT ON (B)(6) 2016, THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF TWO (2) UNSPECIFIED BARD / DAVOL PERFIX PLUG (DEVICE #3 AND DEVICE #4). ALSO, AS REPORTED, THE ATTORNEY ALLEGES ON (B)(6) 2017, THE PATIENT UNDERWENT SURGERY FOR AN UNSPECIFIED BARD / DAVOL PERFIX PLUG (DEVICE #5). AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE VENTRALEX ST (DEVICE #1), 3DMAX (DEVICE #2) AND THREE (3) PERFIX PLUGS (DEVICE #3,DEVICE #4 AND DEVICE #5). AS REPORTED, THE ATTORNEY ALLEGES GENERAL ALLEGATIONS FOR "PAST, PRESENT, AND FUTURE DAMAGES, INCLUDING BUT NOT LIMITED TO, MENTAL AND PHYSICAL PAIN AND SUFFERING FOR SEVERE AND PERMANENT PERSONAL INJURIES SUSTAINED BY THE PATIENT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    384734 VENTRALEX ST SURGICAL MESH FTL DAVOL INC., SUB. C.R. BARD, INC. -1213643 NA HUZG1286 00801741031489

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Disability