BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE POLYPROPYLENE MESH

    MDR report key: 3062347 · Received April 16, 2013

    Report

    Report Number
    2210968-2013-03975
    Event Type
    Injury
    Date Received
    April 16, 2013
    Report Date
    March 29, 2013
    Manufacturer
    ETHICON, INC.
    Product Code
    FTL
    PMA / PMN Number
    K001122
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY.

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE AND MESH WAS IMPLANTED ON (B)(6) 2004 IN ORDER TO TREAT URINARY INCONTINENCE CONCURRENTLY WITH AN EXPLORATORY LAPAROSCOPIC SEGMENTED, TRANSVERSE COLON RESECTION, REMOVAL OF FOREIGN BODY OLD INTRA- ABDOMINAL MESH, PARTIAL OMENTECTOMY, AND JACKSON-PRATT DRAIN FOR TEMPORARY INTRA-PERITONEAL DRAINAGE. IT WAS REPORTED THAT THE PATIENT UNDERWENT A LAPAROSCOPIC INC. HERNIA REPAIR W/ MESH, AND LAPAROSCOPIC LYSIS OF ADHESIONS REQUESTING GREATER THAT ONE HOUR THAT WAS A SIGNIFICANT PORTION OF THE PROCEDURE ON (B)(6) 2009. IT WAS REPORTED THAT THERE WAS A MECHANICAL COMPLICATION OF THE GENITOURINARY DEVICE IMPLANT AND THE GRAFT EDGES OF MESH USED IN VAGINAL REPAIR WERE SEEN TO BE 2/3 OF THE WAY INSIDE THE VAGINA & APEX ON (B)(6) 2010. THE PATIENT ALSO UNDERWENT PERFORATE HOLLOW VISCUS, PERFORATE TRANSVERSE COLON, EXPLORATORY LAPAROSCOPIC SEGMENTED, TRANSVERSE COLON RESECTION, REMOVAL OF FOREIGN BODY OLD INTRA- ABDOMINAL MESH, PARTIAL OMENTECTOMY, AND JACKSON-PRATT DRAIN FOR TEMPORARY INTRA-PERITONEAL DRAINAGE ON (B)(6) 2010. IT WAS REPORTED THAT THE PATIENT HAD A BARD COMPOSIX/LIP MESH IMPLANT ON (B)(6) 2014. NO ADDITIONAL INFORMATION WAS PROVIDED. (B)(4).

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE IN ORDER TO TREAT PELVIC ORGAN PROLAPSED AND MESH WAS IMPLANTED. IT WAS REPORTED THAT FOLLOWING INSERTION OF THE MESH, THE PATIENT EXPERIENCED PAIN, EROSION, EXTRUSION, INFECTION, URINARY/BOWEL PROBLEMS, RECURRENCE, DYSPAREUNIA, VAGINAL SCARRING, ORGAN PERFORATION AND OTHER. (B)(4).

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE AND MESH WAS IMPLANTED CONCURRENTLY WITH ABDOMINAL SACRAL COLPOPEXY, CYSTOSCOPY, SCAR REVISION, LYSIS OF ADHESIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2004 AND MESH WAS IMPLANTED. THE PATIENT EXPERIENCED PAIN, EROSION OF HER INTERNAL BODILY TISSUE AND OTHER INJURIES FOLLOWING THE PROCEDURE. IT WAS REPORTED THAT THE PATIENT HAS UNDERGONE MULTIPLE SURGERIES AND REVISIONARY PROCEDURES. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    162409 PROLENE POLYPROPYLENE MESH MESH, SURGICAL FTL ETHICON, INC. NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention