BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COATED VICRYL (POLYGLACTIN 910) SUTURE

    MDR report key: 234041 · Received August 2, 1999

    Report

    Report Number
    2210968-1999-00382
    Event Type
    Injury
    Date Received
    August 2, 1999
    Date of Event
    June 29, 1999
    Report Date
    July 13, 1999
    Manufacturer
    ETHICON, INC. SAN ANGELO
    Product Code
    GAM
    Removal / Correction Number
    NA
    Report Source
    Manufacturer report

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE TIP OF THE NEEDLE BROKE OFF DURING THE PROCEDURE AND BECAME LODGED IN THE PT. THE PT UNDERWENT A SECOND PROCEDURE TO REMOVE THE NEEDLE TIP ON 07/01/1999. THERE WAS NO FURTHER CONSEQUENCES TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COATED VICRYL (POLYGLACTIN 910) SUTURE Implant SUTURE, ABSORBABLE GAM ETHICON, INC. SAN ANGELO NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1