BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEALON ENDOCOAT

    MDR report key: 7356484 · Received March 20, 2018

    Report

    Report Number
    3004750704-2018-00026
    Event Type
    Malfunction
    Date Received
    March 20, 2018
    Date of Event
    October 17, 2017
    Report Date
    September 29, 2018
    Manufacturer
    JOHNSON & JOHNSON SURGICAL VISION, INC.
    Product Code
    LZP
    UDI-DI
    05050474547063
    PMA / PMN Number
    P110007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE PRODUCT TESTING COULD NOT BE PERFORMED AS THE PRODUCT WAS NOT RETURNED. THE REPORTED COMPLAINT CANNOT BE CONFIRMED. THE MANUFACTURING PROCESS RECORD WAS EVALUATED AND NO DEVIATION WAS FOUND DURING PROCESS RELATED TO THE COMPLAINT ISSUE REPORTED. THERE WAS NO DISCREPANCY FOUND DURING THE MRR (MANUFACTURING RECORD REVIEW). THE PRODUCT WAS MANUFACTURED AND RELEASED ACCORDING TO SPECIFICATIONS. A REVIEW OF COMPLAINTS FOR THIS LOT NUMBER REVEALED NO SIMILAR COMPLAINTS AT THE TIME OF THE REVIEW. COMPLAINT REVIEW INDICATES NO RELATED TRENDS. THE DIRECTIONS FOR USE (DFU) WAS REVIEWED. THE DFU ADEQUATELY PROVIDES INSTRUCTIONS AND PRECAUTIONS FOR THE PROPER USE AND HANDLING OF THE PRODUCT. BASED ON THE INVESTIGATION RESULTS THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    AGE/DATE OF BIRTH: NOT APPLICABLE AS THERE WAS NO PATIENT CONTACT OR IMPACT. GENDER/SEX: NOT APPLICABLE AS THERE WAS NO PATIENT CONTACT OR IMPACT. IF IMPLANTED, GIVE DATE: NOT APPLICABLE AS THIS IS NOT AN IMPLANTABLE DEVICE.  IF EXPLANTED, GIVE DATE: NOT APPLICABLE AS THIS IS NOT AN IMPLANTABLE DEVICE.  DEVICE MANUFACTURE DATE: UNKNOWN AT THE TIME OF THIS REPORT. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN CUSTOMER OPENED THE BOX OF VT585U HEALON ENDOCOAT, THE PEEL PACK WAS ALREADY UNPEELED. NO PATIENT CONTACT REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    195206 HEALON ENDOCOAT OVDS LZP JOHNSON & JOHNSON SURGICAL VISION, INC. VT585U 026650 05050474547063

    Patients

    Seq Age Sex Outcome Treatment
    1