BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CUSTOM PAK

    MDR report key: 2500184 · Received March 21, 2012

    Report

    Report Number
    1644019-2012-00022
    Event Type
    Injury
    Date Received
    March 21, 2012
    Date of Event
    February 17, 2012
    Report Date
    February 20, 2012
    Manufacturer
    ALCON - HOUSTON
    Product Code
    KYG
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER'S COMPLAINT HISTORY WAS REVIEWED FOR ONE YEAR; THIS IS THE FIRST COMPLAINT REPORTED FOR THIS ISSUE. THERE ARE NO OTHER COMPLAINTS REPORTED FOR THIS FINISHED GOOD LOT. THE ORDER WAS BUILT AND RELEASED PER SPECIFICATION. A REVIEW OF CURRENT WAREHOUSE STOCK FOUND NO ANOMALIES. THERE HAVE BEEN NO CHANGES MADE TO THE DRAPE ADHESIVE. A ROOT CAUSE COULD NOT BE DETERMINED WITHOUT A SAMPLE. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THE ADHESIVE OF THE DRAPE CAUSED A SKIN TEAR, ON A PATIENT WHEN IT WAS REMOVED FROM AROUND THE EYE. THE THEATRE STAFF NOTED THAT THE SKIN WAS "DELICATE". ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CUSTOM PAK CONVENIENCE KIT KYG ALCON - HOUSTON CUSTOM PAK 1230759H

    Patients

    Seq Age Sex Outcome Treatment
    1 Other