BEUDAMED
    FDA Adverse Event Other Summary report: N

    BIOPATCH 9150

    MDR report key: 1399108 · Received May 29, 2009

    Report

    Report Number
    1121308-2009-00012
    Event Type
    Other
    Date Received
    May 29, 2009
    Date of Event
    April 22, 2009
    Report Date
    May 29, 2009
    Manufacturer
    INTEGRA NEUROSCIENCES PR
    Product Code
    FRO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE, THE DEVICES INVOLVED IN THE REPORTED INCIDENT HAVE NOT BEEN RECEIVED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFORMATION. A HEALTH HAZARD EVALUATION PROVIDED BY ETHICON INC. IS ATTACHED.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE DISTRIBUTOR ETHICON INC. THAT ETHICON RISK MANAGEMENT STATED THAT (B)(4) SOLD BIOPATCH WITH BULK NON-STERILE PRODUCT CODE 9150 (ONE CASE CONTAINING 500 INDIVIDUAL BIOPATCH UNITS) DIRECTLY TO A HOSPITAL. THE BIOPATCH CATALOG NO. 9150 IS SOLD NON-STERILE TO BE FURTHER PROCESSED TO THE CUSTOMER J AND J WOUND MANAGEMENT, A DIVISION OF ETHICON INC. BY INTEGRA. THE FINISHED GOOD IS PACKED INDIVIDUALLY IN A BLUE BLISTER SEALED WITH A TYVEK, WHICH DOES NOT INDICATE PRODUCT IS STERILE. ONE HUNDRED UNITS ARE PLACED IN A ZIPPERED POLY BAG AND IDENTIFIED AS NON-STERILE USING A SHIPPER LABEL. FIVE OF THESE POLY BAGS ARE PLACED IN A CORRUGATED CARTON, WHICH IS THEN SHIPPED TO CUSTOMER WITH A SHIPPER LABEL IDENTIFYING THE CONTENTS AS: 5 X 100 AND NON-STERILE. THE PACKAGING AND SHIPPING LABELING OF THE BIOPATCH CATALOG NO. 9150, 9151 AND 9151 AND 9152 IS COMPLETELY DIFFERENT FROM THE BIOPATCH CATALOG NO. 3150, 3151 AND 3152, WHICH IS THE STERILE PRODUCT, PACKED IN BLISTERS AND THEN INTO A DISPENSER BOX CONTAINING TEN INDIVIDUALLY PACKED UNITS. NINE BIOPATCHES OUT OF 500 WERE USED ON MORE THAN ONE PATIENT. TO DATE NO ADVERSE PATIENT EVENTS HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOPATCH 9150 BIOPATCH FRO INTEGRA NEUROSCIENCES PR

    Patients

    Seq Age Sex Outcome Treatment
    1