BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NYLON SUTURE UNKNOWN PRODUCT

    MDR report key: 7765215 · Received August 8, 2018

    Report

    Report Number
    2210968-2018-75027
    Event Type
    Injury
    Date Received
    August 8, 2018
    Report Date
    July 20, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    GAR
    PMA / PMN Number
    K946173
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT IS RELATED TO A JOURNAL ARTICLE, THEREFORE NO PRODUCT WILL BE RETURNED FOR ANALYSIS AND THE BATCH HISTORY RECORDS CANNOT BE REVIEWED AS THE LOT NUMBER HAS NOT BEEN PROVIDED. ATTEMPTS ARE BEING MADE TO OBTAIN THE FOLLOWING INFORMATION. IF FURTHER DETAILS ARE RECEIVED AT THE LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. DOES THE SURGEON BELIEVE THAT ETHICON PRODUCTS INVOLVED CAUSED AND/OR CONTRIBUTED TO THE POST-OPERATIVE COMPLICATIONS DESCRIBED IN THE ARTICLE? DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH THE ETHICON PRODUCT (ETHIBOND OR NYLON SUTURE) USED IN THIS PROCEDURE? CITATION: J RECONSTR MICROSURG. 2014; 30: 581 584. DOI: HTTP://DX.DOI.ORG/10.1055/S-0034-1383427. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE TITLE : MICROVASCULAR PENILE REPLANTATION UTILIZING THE DEEP INFERIOR EPIGASTRIC VESSELS AUTHOR: MARK M. LEYNGOLD, MD, CARLOS M. RIVERA-SERRANO, MD CITATION: J RECONSTR MICROSURG. 2014; 30: 581 584. DOI: HTTP://DX.DOI.ORG/10.1055/S-0034-1383427. TRAUMATIC PENILE AMPUTATION IS AN UNCOMMON OCCURRENCE DESCRIBED IN PSYCHIATRIC PATIENTS WITH ACUTE PSYCHOSIS, BUT CAN ALSO BE A CONSEQUENCE OF ACCIDENTS, CIRCUMCISION, ASSAULT OR DOMESTIC VIOLENCE. A (B)(6)MALE PRISONER WITH A HISTORY OF GENDER IDENTITY DISORDER AND SCHIZOPHRENIA WAS RUSHED TO OUR HOSPITAL AFTER A SELF-INFLICTED PENILE AMPUTATION WITH A KNIFE. DURING THE SURGICAL PROCEDURE, THE PROXIMAL AND DISTAL ARTERIAL TO SAPHENOUS VEIN ANASTOMOSIS WERE HAND SEWN WITH AN INTERRUPTED NYLON 8-O SUTURE WITH BV130¿5 NEEDLE (ETHICON) UNDER 3.5 LOOP MAGNIFICATION. PENIS WAS WELL PERFUSED WITH AUDIBLE EXTERNAL DOPPLER SIGNALS OVER THE GLANS AFTER COMPLETION OF ALL ANASTOMOSIS. ABDOMINAL FASCIA WAS REPAIRED WITH AN ETHIBOND 0 SUTURE (ETHICON) LEAVING A SMALL FASCIAL DEFECT FOR THE VESSELS. REPORTED COMPLICATIONS INCLUDED PENILE REPLANT CONGESTION ON POST-OPERATIVE DAY 1 WHICH REQUIRED MEDICINAL LEECH THERAPY AND PENILE SKIN NECROSIS WHICH REQUIRED DEBRIDEMENT AND SKIN GRAFTING. THE DEEP INFERIOR EPIGASTRIC VESSELS OFFER A ROBUST FLOW AND ARE SUITABLE AS RECIPIENT VESSELS IN CASES OF PENILE REPLANTATION WHEN LOCAL ALTERNATIVES ARE UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    605922 NYLON SUTURE UNKNOWN PRODUCT SUTURE, NONABSORBABLE, SYNTHETIC GAR ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Required Intervention