BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROXIMATE*PPH PROCEDURE SET

    MDR report key: 8703880 · Received June 17, 2019

    Report

    Report Number
    3005075853-2019-19789
    Event Type
    Injury
    Date Received
    June 17, 2019
    Date of Event
    January 1, 2012
    Report Date
    May 24, 2019
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    UDI-DI
    10705036013006
    PMA / PMN Number
    K051301
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT #: (B)(4). DATE OF EVENT: PUBLICATION YEAR OF 2012. BATCH # UNK. THE LOT/BATCH WAS NOT PROVIDED; THEREFORE, THE MANUFACTURING RECORDS COULD NOT BE REVIEWED. THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS THROUGH A JOURNAL ARTICLE. NO SPECIFIC PATIENT INFORMATION REGARDING EVENTS HAS BEEN PROVIDED AND IT IS UNKNOWN IF THE EVENTS HAVE BEEN PREVIOUSLY REPORTED. THEREFORE, ONE MEDWATCH SENT. IF FURTHER DETAILS ARE RECEIVED AT THE LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA LITERATURE ENTITLED: CAN YOGA IMPROVE THE OUTCOME OF SURGERY FOR HAEMORRHOIDS? A PROSPECTIVE RANDOMIZED CONTROLLED STUDY. AUTHORS: BRIJ B. AGARWAL, SHRUTI SHARMA, MANISH K. GUPTA, RATHINDRA SARANGI, KRISHAN C. MAHAJAN. CITATION: JIMSA JANUARY-MARCH 2012 VOL. 25 NO. 1. PROCEDURE FOR PROLAPSE AND HEMORRHOIDS (PPH) FOR SYMPTOMATIC HEMORRHOIDS HAS BECOME POPULAR. OUTCOMES OF PPH CAN BE FURTHER IMPROVED BY ADDRESSING SYMPTOMS LIKE POSTOPERATIVE PAIN. THIS STUDY WAS UNDERTAKEN TO ASSESS THE IMPACT OF YOGA EXERCISES ON THE OUTCOMES OF PPH. FROM DECEMBER 2005 TO NOVEMBER 2007, 100 CONSECUTIVE CANDIDATES FOR PPH WERE PROSPECTIVELY RANDOMIZED AND AN INFORMED CONSENT WAS TAKEN FOR DAY CARE SURGERY. CONTROL GROUP (N-50; AGE RANGE: 22 TO 84 YEARS OLD; 40 MALE AND 10 FEMALE PATIENTS) HAD PPH WITHOUT ANY PERI-OPERATIVE YOGA EXERCISES. STUDY GROUP (N-50; AGE RANGE: 23 TO 86 YEARS OLD; 42 MALE AND 8 FEMALE PATIENTS) HAD PPH WITH PERI-OPERATIVE YOGA EXRCISES. DURING THE SURGICAL PROCEDURE IN ALL GROUPS, STANDARD TECHNIQUE FOR PPH AS DESCRIBED IN LITERATURE WITHOUT ANY VARIATION WAS FOLLOWED. A STANDARD PPH03 33 MM CIRCULAR HEMORRHOID STAPLER (ETHICON) WAS USED AS REPORTED BY OTHERS. HEMOSTASIS WAS ALWAYS ENSURED AT THE COMPLETION OF THE PROCEDURE. REPORTED OVERALL COMPLICATIONS IN BOTH GROUPS INCLUDED POST-OPERATIVE PAIN (N-62), PAINFUL DEFECATION (N-75), PERI-ANAL IRRITATION, BURNING, OR PRURITUS (N-56), AND POST-OPERATIVE BLEEDING OR REACTIONARY HEMORRHAGE (N-2) NEEDING SURGICAL INTERVENTION, BLOOD TRANSFUSION, AND HOSPITALIZATION FOR 3 DAYS. IT WAS CONCLUDED THAT YOGA EXERCISES CAN BE EASILY OFFERED TO PATIENTS FOR PPH WITH IMPROVED OUTCOMES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    499679 PROXIMATE*PPH PROCEDURE SET STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. 10705036013006

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R