BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ETHISORB UNKNOWN

    MDR report key: 7118588 · Received December 14, 2017

    Report

    Report Number
    2210968-2017-71794
    Event Type
    Injury
    Date Received
    December 14, 2017
    Report Date
    November 24, 2017
    Manufacturer
    ETHICON INC.
    Product Code
    GXQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). (B)(4). TO DATE, THE DEVICE HAS NOT BEEN RETURNED. IF THE PRODUCT IS RETURNED FOR EVALUATION, ANY FURTHER INFORMATION DERIVED FROM THE EVALUATION WILL BE SUBMITTED IN A SUPPLEMENTAL 3500A FORM. ATTEMPTS ARE BEING MADE TO OBTAIN THE FOLLOWING INFORMATION. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. WERE THE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER. DOES THE SURGEON BELIEVE THAT ETHICON PRODUCT ETHISORB OR PDS PLATE CAUSED AND/OR CONTRIBUTED TO THE ADVERSE EVENTS DESCRIBED IN THE ARTICLE? CAN SPECIFIC PATIENT DEMOGRAPHICS BE PROVIDED FOR THE SUBJECTS OF THIS ARTICLE? IF SO, PLEASE ALSO INCLUDE: PATIENT INITIALS, INITIAL PROCEDURE DATE, PRE-EXISTING CONDITIONS, SPECIFIC MEDICAL/SURGICAL INTERVENTION PER PATIENT. IS THE PRODUCT CODE AND LOT NUMBER AVAILABLE FOR ANY OF THE ETHICON DEVICES USED? CITATION: CLIN ORAL INVEST (2011) 15:305¿313. DOI 10.1007/S00784-010-0385-Y.

    Description of Event or Problem · 1

    IT WAS REPORTED IN A JOURNAL ARTICLE (TITLE: RETROSPECTIVE ANALYSIS OF ORBITAL FLOOR FRACTURES¿COMPLICATIONS, OUTCOME, AND REVIEW OF LITERATURE) THAT PATIENT UNDERWENT PRIMARY ORBITAL FLOOR RECONSTRUCTION ON UNKNOWN DATE AND PATCH WAS USED FOR STANDARD ORBITAL FLOOR REPAIR. A RETROSPECTIVE REVIEW OF PROCEDURES PERFORMED BETWEEN 01/2003 AND 12/2007. THE PATIENT POSSIBLY EXPERIENCED DIPLOPIA, MOTILITY IMPAIRMENT, AND/OR ENOPHTHALMOS/HYPOPHTHALMOS. THE PATIENT POSSIBLY REQUIRED REVISION SURGERY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    895562 ETHISORB UNKNOWN ABSORBABLE, SYNTHETIC PATCH GXQ ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention