BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT

    MDR report key: 7674965 · Received July 10, 2018

    Report

    Report Number
    2210968-2018-74221
    Event Type
    Injury
    Date Received
    July 10, 2018
    Report Date
    June 18, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    GAW
    PMA / PMN Number
    K133356
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). TO DATE THE DEVICE HAS NOT BEEN RETURNED. IF THE DEVICE OR FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. ATTEMPTS ARE BEING MADE TO OBTAIN THE FOLLOWING INFORMATION. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. DOES THE SURGEON BELIEVE THAT THE ETHICON PRODUCT INVOLVED CAUSED AND/OR CONTRIBUTED TO THE POSTOPERATIVE COMPLICATIONS DESCRIBED IN THE ARTICLE? IF YES, PLEASE EXPLAIN DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH THE ETHICON PRODUCT USED IN THIS PROCEDURE? IF YES, PLEASE EXPLAIN HAS THE COMPLAINT BEEN PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE COMPLAINT NUMBER CITATION: UROLOGY. 2014; 84: 472 474. DOI: HTTP://DX.DOI.ORG/10.1016/J.UROLOGY.2014.04.021 (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE: "TITLE: COMPLETE PENILE AMPUTATION DURING RITUAL NEONATAL CIRCUMCISION AND SUCCESSFUL REPLANTATION USING POSTOPERATIVE LEECH THERAPY" AUTHOR: OMAYA I. BANIHANI, JANELLE A. FOX, BRIAN H. GANDER, LORELEI J. GRUNWALDT, AND GLENN M. CANNON CITATION: UROLOGY. 2014; 84: 472 474. DOI: HTTP://DX.DOI.ORG/10.1016/J.UROLOGY.2014.04.021 A (B)(6) NEONATE PRESENTED TO THE EMERGENCY ROOM OF A TERTIARY CARE (B)(6) HOSPITAL LESS THAN 1 HOUR AFTER HIS PENIS WAS AMPUTATED DURING RITUALISTIC CIRCUMCISION. THE INJURY WAS THE EQUIVALENT OF A TOTAL PENECTOMY. THE PATIENT WAS IN THE STATE OF HEMORRHAGIC SHOCK UPON ARRIVAL. DURING THE SURGICAL PROCEDURE, THE PLASTIC SURGERY TEAM PERFORMED MICROVASCULAR ANASTOMOSES OF THE BILATERAL DORSAL ARTERIES WITH ETHILON INTERRUPTED SUTURES USING THE OPERATING MICROSCOPE. SKIN CLOSURE AT THE BASE OF THE PENIS WAS COMPLETED WITH INTERRUPTED MONOCRYL SUTURES; ALSO USED WERE 4 QUADRANT PROLENE SUTURES TO IDENTIFY THE ANASTOMOTIC EDGE, SHOULD SKIN NECROSIS OCCUR. ON POSTOPERATIVE DAY (POD) 1, SIGNS OF VENOUS CONGESTION WERE EVIDENT; THE PENILE SHAFT AND GLANS WERE SWOLLEN, DUSKY, WARM, AND BLED DARK BLOOD WHEN PUNCTURED WITH A NEEDLE. THE PLASTIC SURGERY AND UROLOGY TEAMS TOGETHER DECIDED TO USE MEDICINAL LEECH THERAPY TO ALLEVIATE VENOUS CONGESTION RELATED ISCHEMIA. ANTIBIOTICS WERE SWITCHED TO CEFEPIME TO COVER LEECH ORAL FLORA. ON 2 OCCASIONS, VICRYL 6-0 SUTURES HAD TO BE PLACED AT LEECH SITES AFTER DETACHMENT FOR ACTIVE BLEEDING, WHICH COULD NOT BE CONTROLLED WITH FIRM PRESSURE. OTHER REPORTED COMPLICATION INCLUDED SUPERFICIAL SHAFT SKIN NECROSIS WHICH WAS MANAGED CONSERVATIVELY WITH DRESSING CHANGES. THE AUTHORS BELIEVED THAT WITH THE ASSISTANCE OF SUFFICIENT MAGNIFICATION, NEONATAL MICROVASCULAR PENILE REPLANTATION IS STILL POSSIBLE

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    514961 PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT SUTURE, NONABSORBABLE GAW ETHICON INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 7 DA Required Intervention