BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HENRY SCHEIN SURGICAL SUTURE

    MDR report key: 1066924 · Received June 27, 2008

    Report

    Report Number
    2522801-2008-00019
    Event Type
    Malfunction
    Date Received
    June 27, 2008
    Date of Event
    May 21, 2008
    Report Date
    June 26, 2008
    Manufacturer
    SURGICAL SPECIALTIES CORP (DBA ANGIOTECH)
    Product Code
    GAS
    PMA / PMN Number
    K926586
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER/DISTRIBUTOR INDICATED THAT THE NEEDLES INVOLVED IN THE INCIDENT ARE AVAILABLE FOR EVAL. HOWEVER, AS OF THE DATE OF THIS REPORT, THE NEEDLES HAVE NOT BEEN RETURNED TO ANGIOTECH. A REVIEW OF THE DEVICE HISTORY RECORD FOR THE RAW SUTURE MATERIAL, NEEDLE/SUTURE ASSEMBLY AND FINISHED GOOD LOT INDICATES THAT THE PRODUCT MET SPECIFICATION. NO OTHER COMPLAINTS HAVE BEEN RECEIVED FOR PRODUCT 101-1582, LOT M284830.

    Description of Event or Problem · 1

    TWO (2) NEEDLES "BROKE OFF" IN A PT'S MOUTH DURING A SUTURING PROCEDURE. THE NEEDLES APPARENTLY BROKE AT THE SWAGE AREA. IN BOTH CASES, THE DOCTOR WAS ABLE TO RETRIEVE THE NEEDLE FROM THE PT'S MOUTH. THE PT DID NOT REQUIRE ANY "MEDICAL ATTENTION."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HENRY SCHEIN SURGICAL SUTURE SUTURE AND NEEDLE GAS SURGICAL SPECIALTIES CORP (DBA ANGIOTECH) 101-1582 M284830

    Patients

    Seq Age Sex Outcome Treatment
    1 Other NONE MADE AVAILABLE.