BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROXIMATE*HCS HEMORR CIR STAPL (EXACT CODE UNKNOWN

    MDR report key: 2230555 · Received September 1, 2011

    Report

    Report Number
    1527736-2011-00153
    Event Type
    Injury
    Date Received
    September 1, 2011
    Report Date
    August 12, 2011
    Manufacturer
    ETHICON ENDO SURGERY, INC (CINCINNATI)
    Product Code
    GDW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION IS UNAVAILABLE; DEVICE WAS NOT RETURNED FOR EVALUATION. ADDITIONAL INFORMATION: THE PATIENT CALLED AND ALSO MENTIONED THAT SHE HAD THREE SURGERIES IN 2010 BECAUSE HER RECTUM WAS CLOSING AND FOR BLADDER PROLAPSE. PATIENT REPORTED THAT SHE BELIEVES THAT THE STAPLES HAVE "CLOSED HER RECTUM." THE COMPLAINT COULD NOT BE CONFIRMED BECAUSE NO DEVICE WAS RETURNED FOR ANALYSIS. WE DID NOT RECEIVE A BATCH OR LOT NUMBER FOR THE PRODUCT INVOLVED IN THIS COMPLAINT. THEREFORE, WE WERE UNABLE TO CHECK MANUFACTURING RECORDS FOR ANY RELATED NON-CONFORMANCES. COMPLAINT INFORMATION IS TRENDED ON A REGULAR BASIS TO DETERMINE IF FURTHER INVESTIGATION IS WARRANTED.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PATIENT¿S DAUGHTER THAT POST OP OF A PPH PROCEDURE THAT WAS COMPLETED ON (B)(6), 2003, SINCE THEN THE PATIENT HAS HAD PINCHING FROM THE STAPLES AT THE RECTUM, HAS A HARD TIME WALKING AND A HARD TIME SITTING. ON TWO SEPARATE OCCASIONS IN 2010, THE PATIENT HAS HAD STAPLES SURGICALLY REMOVED THAT WERE TWISTED IN THE TISSUE. AT THAT TIME, ALL THE SCAR TISSUE WAS CUT OUT; THE PATIENT HAS NO MUSCLE LEFT TO HOLD BOWEL MOVEMENTS. THE SURGEON HAS SUGGESTED A COLOSTOMY AND THE PATIENT REFUSES. WHATEVER SHE EATS GOES RIGHT THROUGH THE PATIENT. THE SURGEON SAID THERE IS NOTHING ELSE THEY CAN DO FOR HER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROXIMATE*HCS HEMORR CIR STAPL (EXACT CODE UNKNOWN PROXIMATE** HCS (PPH) SET GDW ETHICON ENDO SURGERY, INC (CINCINNATI) NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R