BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEURO-PATCH 1.5X3CM

    MDR report key: 8741301 · Received June 27, 2019

    Report

    Report Number
    9610612-2019-00430
    Event Type
    Malfunction
    Date Received
    June 27, 2019
    Date of Event
    June 3, 2019
    Report Date
    September 13, 2019
    Manufacturer
    AESCULAP AG
    Product Code
    GXQ
    PMA / PMN Number
    K960470
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURING SITE EVALUATION: THE PRODUCT IS PROVIDED IN THE ORIGINAL PACKAGING AND SHOWS A HAIR IN THE SECONDARY STERILE BARRIER. INVESTIGATION - VISUALLY AND MICROSCOPICALLY EXAMINED. THE HAIR IS LOCATED WITHIN THE SECONDARY STERILE BARRIER. IT GOT STUCK BETWEEN THE PRODUCT LABEL AND THE OUTER SURFACE OF THE BLISTER, AND IT CANNOT BE REMOVED FROM THE BLISTER. BATCH HISTORY REVIEW - THE DEVICE QUALITY AND MANUFACTURING HISTORY RECORDS HAVE BEEN CHECKED FOR THE LOT NUMBER AND FOUND TO BE ACCORDING TO OUR SPECIFICATIONS VALID AT THE TIME OF PRODUCTION. NO SIMILAR INCIDENTS HAVE BEEN FILED WITH PRODUCTS FROM THIS BATCH. CONCLUSION AND ROOT CAUSE - BASED ON THE INFORMATION AVAILABLE AS WELL AS A RESULT OF OUR INVESTIGATION THE ROOT CAUSE OF THE FAILURE IS MOST LIKELY RELATED TO A MANUFACTURING ERROR. RATIONALE - AS THE PRODUCT HAS BEEN RECEIVED IN ITS ORIGINAL PACKAGING, IT APPEARS THAT THE HAIR COMES FROM AN EMPLOYEE IN THE CLEAN ROOM AND HAS NOT BEEN FOUND DURING THE FINAL INSPECTION. THE MANUFACTURING DEPARTMENT WILL BE INFORMED ABOUT THE ISSUE.

    Additional Manufacturer Narrative · 0

    AESCULAP INC. (IMPORTER, REGISTRATION NO. 2916714) IS SUBMITTING THIS REPORT ON BEHALF OF AESCULAP AG (MANUFACTURER, REGISTRATION NO. 9610612). EXEMPTION NUMBER: E2014018. MANUFACTURING SITE EVALUATION: INVESTIGATION ON-GOING. ADDITIONAL INFORMATION / INVESTIGATION RESULTS WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WAS AN ISSUE WITH THE NEURO PATCH. PRIOR TO SURGERY, IT WAS DETECTED THAT THERE WAS A HAIR INSIDE THE STERILE PACKAGE. ANOTHER PRODUCT WAS AVAILABLE AND IT WAS USED INSTEAD. THERE WAS NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    535693 NEURO-PATCH 1.5X3CM DURA REPLACEMENT GXQ AESCULAP AG 1064061 216273

    Patients

    Seq Age Sex Outcome Treatment
    1