BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROXIMATE*PPH PROCEDURE SET

    MDR report key: 2023784 · Received March 18, 2011

    Report

    Report Number
    3005075853-2011-01083
    Event Type
    Injury
    Date Received
    March 18, 2011
    Report Date
    February 24, 2011
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K051301
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DATE SENT: 03/18/2011. DATE OF EVENT: (B)(6) 2006. INFORMATION WAS NOT PROVIDED BY THE AFFILIATE. INFORMATION IS UNAVAILABLE; DEVICE WAS NOT RETURNED FOR EVALUATION. NO PRODUCT TO BE RETURNED. ADDITIONAL INFORMATION RECEIVED ON 2/25/2011. THE PATIENT IS SUING THE SURGEON FOR THE ORIGINAL PPH PROCEDURE- PATIENT BELIEVES PPH PROCEDURE MAY HAVE BEEN INAPPROPRIATE CHOICE OF PROCEDURE. ADDITIONAL INFORMATION REQUESTED ON 3/1/2011: (B)(6). ADDITIONAL INFORMATION RECEIVED ON 3/3/2011: I AM AFRAID WE DO NOT HAVE THE DETAILS. THE SCENARIO IS THAT THE SURGEON HAS REQUESTED INFORMATION PERTAINING TO PPH03 THAT WAS AVAILABLE IN 2006/7. THE REASON IS THAT HE COMPLETED A PROCEDURE ON A FEMALE PATIENT AT THAT TIME. THE PATIENT IS NOW TAKING SOME LEGAL ACTION AGAINST HIM SUGGESTING THAT THE PROCEDURE SELECTION WAS NOT THE CORRECT CHOICE. WE HAVE NO PRODUCT (IT WAS (B)(6) YEARS AGO). WE DO NOT HAVE DETAIL OF THE DATE OF THE PROCEDURE OR OF ANY SUBSEQUENT PROCEDURES. ALTHOUGH THERE WAS SOME BLEEDING AT THE TIME, THIS WAS NOT RAISED AS A PRODUCT COMPLAINT. THERE IS NO SUGGESTION FROM THE SURGEON THAT THE PRODUCT DID NOT PERFORM AS EXPECTED. IT IS UNLIKELY THAT THE SURGEON WILL PROVIDE US WITH ANY FURTHER INFORMATION. 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. (B)(6).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SURGEON PERFORMED A HEMORRHOIDECTOMY ON A PATIENT. THERE WAS SOME BLEEDING ON THE STAPLE LINE AND THE PATIENT WAS RE-ADMITTED WITH BLEEDING. FOLLOWING THE PROCEDURE THE PATIENT HAD A STARR PROCEDURE. THIS PROCEDURE DID NOT SOLVE THE MEDICAL CONDITION. THE PATIENT EVENTUALLY HAD A "PROSTATECTOMY".

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| O| R