BEUDAMED
    FDA Adverse Event Other Summary report: N

    RITE AID

    MDR report key: 3284652 · Received August 5, 2013

    Report

    Report Number
    1038758-2013-00018
    Event Type
    Other
    Date Received
    August 5, 2013
    Report Date
    August 1, 2013
    Manufacturer
    ASO LLC
    Product Code
    KGX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ASO REVIEWED THE FOLLOWING RECORDS FOR TESTING PERFORMED ON SIMILAR LOTS OF PRODUCT. (B)(4), LOT TR-06-141-001 120GM/SQUARED LOT NUMBER 200611-25-1 AND LOT TR-05-063-001, LOT 2005-06-01. (B)(4), LOT TR-06-141-001, 120GM LOT NUMBER 200611-25-1 AND LOT TR-05-063-001, LOT 2005-06-01. (B)(4) STUDY USING THE ISO AGAROSE OVERLAY METHOD - LOT TR-06-141-001 120GM/SQUARED LOT NUMBER 200611-25-1 AN ASTM (B)(4), LOT TR-05-063-001, LOT NUMBER 2005-06-01. ALL TESTING WAS ACCEPTABLE.

    Description of Event or Problem · 1

    ON (B)(6) 2013, END USER REPORTED HAVING A RASH FROM USING THE BANDAGES. THE END USER WENT TO THE EMERGENCY ROOM AND SOUGHT TREATMENT FOR THE RASH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    366427 RITE AID FABRIC BANDAGES KGX ASO LLC 011822312035 7 1/13 4492-3

    Patients

    Seq Age Sex Outcome Treatment
    1 Other