BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GOWN PLR-X

    MDR report key: 3008167 · Received March 11, 2013

    Report

    Report Number
    3008167
    Event Type
    Malfunction
    Date Received
    March 11, 2013
    Date of Event
    March 6, 2013
    Report Date
    March 11, 2013
    Manufacturer
    SYNERGY HEALTH AST, LLC
    Product Code
    FYA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    SC, US

    Narratives

    Description of Event or Problem · 1

    THE REUSABLE SURGEON GOWN WAS SENT IN WITH A HOLE IN THE SLEEVE. WE HAVE HAD OTHER OCCASIONS WITH GOWNS COMING IN WITH HOLES IN THEM. THE GOWN WAS NOT USED IN A SURGICAL CASE WITH A PATIENT. A NEW GOWN WAS OBTAINED. NO PATIENT HARM.======================MANUFACTURER RESPONSE FOR XL REUSABLE SURGEON'S GOWN, (BRAND NOT PROVIDED) (PER SITE REPORTER).======================WHEN REPORTED, WE WERE TOLD THAT QUALITY CONTROL WILL CONTACT US BUT WE HAVEN'T HEARD ANYTHING THING ELSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    102228 GOWN PLR-X GOWN, SURGICAL FYA SYNERGY HEALTH AST, LLC 131004 *

    Patients

    Seq Age Sex Outcome Treatment
    1 *