BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERI-GUARD

    MDR report key: 115878 · Received August 25, 1997

    Report

    Report Number
    2183620-1997-00015
    Event Type
    Injury
    Date Received
    August 25, 1997
    Date of Event
    June 23, 1997
    Report Date
    August 25, 1997
    Manufacturer
    BIO-VASCULAR, INC.
    Product Code
    DXZ
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    PERI-GUARD WAS IMPLANTED AS A DRAINAGE IMPLANT COVER FOR A GLAUCOMA PT ON 03/10/1997. ON 04/23/1997, THE PERI-GUARD PATCH BECAME EXPOSED AND WAS EXPLANTED ON 06/23/1997. THIS INFO WAS BOUGHT BY BVI FOR A RETROSPECTIVE ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERI-GUARD Implant SURGICAL PATCH DXZ BIO-VASCULAR, INC. PC-0404 PGR-96H21-083

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention