BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROXIMATE PPH PROCEDURE SET

    MDR report key: 3033699 · Received April 3, 2013

    Report

    Report Number
    3005075853-2013-01574
    Event Type
    Injury
    Date Received
    April 3, 2013
    Report Date
    March 8, 2013
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K051301
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IN A CONVERSATION WITH THE ATTENDING SURGEON, SHE INDICATED THAT SHE HAD NOT HEARD OF ANY ISSUES FROM THE PATIENT, BUT THAT SHE WOULD FOLLOW UP WITH THE PATIENT. SHE STATED THAT THERE WERE NO PRODUCT COMPLAINT ISSUES. IN A CONVERSATION WITH THE SURGEON WHO IS CARING FOR THE PATIENT NOW, HE STATED THAT THE PATIENT'S COMPLICATIONS WERE DUE TO USER ERROR AND NOT RELATED TO A DEVICE ISSUE. HE ALSO INDICATED THAT HE REMOVED PART OF THE STAPLE LINE AND HAS HAD TO DILATE THE PATIENT A FEW TIMES. HE STATES THE PATIENT CONDITION IS SLOWLY IMPROVING.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE CONSUMER'S HUSBAND STATING THAT HIS WIFE UNDERWENT A RECTAL PROLAPSE AND HEMORRHOIDECTOMY PROCEDURE ON (B)(6) 2012, THE PATIENT (WIFE) WAS RELEASED AND SENT HOME. THE PATIENT FOLLOWED WITH THE SURGEON ONE WEEK LATER WITH PAIN. THE PATIENT WAS GIVEN PAIN PILLS AND CORTISONE CREAM. SHE THEN HAD THREE ANUS ENLARGEMENTS WITH REMOVAL OF STAPLES. SHE REMAINS IN PAIN. THE ORIGINAL SURGEON WENT ON MATERNITY LEAVE AND THE PATIENT WAS SEEN BY AN ASSOCIATE SURGEON. POST OP SURGERIES WERE ON (B)(6) 2012 RECTAL STRICTURE WITH THE REMOVAL OF STAPLES, (B)(6) 2012 AND (B)(6) 2012 ANUS ENLARGEMENTS WITH REMOVAL OF STAPLES .THE PATIENT IS NOW BEING TOLD SHE MAY NEED A COLOSTOMY DUE TO THE ISSUES SHE ENCOUNTERED WITH THE ORIGINAL SURGERY. THIS WAS RECOMMENDED BY THE SECOND SURGEON. CALLER REPORTS THAT HIS WIFE'S PAIN IS UNBEARABLE. SHE HAS BEEN TAKING VICODIN AND HYDROCODONE FOR ONE YEAR FOR THE PAIN. CALLER ALSO REPORTS BLEEDING DAILY AND THE INABILITY TO SIT FOR ANY PERIOD OF TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    137133 PROXIMATE PPH PROCEDURE SET STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention