BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCLERAL BUCKLING PRODUCTS: STYLE 70, SILICONE SLEEVE

    MDR report key: 7346826 · Received March 16, 2018

    Report

    Report Number
    1222074-2018-00053
    Event Type
    Injury
    Date Received
    March 16, 2018
    Date of Event
    February 4, 2015
    Report Date
    February 4, 2015
    Manufacturer
    D.O.R.C DUTCH OPHTHALMIC INTERNATIONAL BV
    Product Code
    HQX
    UDI-DI
    08717872014319
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    LOT REVIEW: THERE IS NOTHING RELATIVE TO THE COMPLAINT. THE MATERIAL USED IS MEDICAL GRADE IMPLANTABLE SILICONE. AFTER TESTING THE ROOT CAUSE IS INCONCLUSIVE FOR AN ALLERGIC REACTION. THIS COMPLAINT IS CONSIDERED AN ISOLATED INCIDENT. SAMPLE ANALYSIS: NO SAMPLE WAS RECEIVED. CONCLUSION: THE COMPLAINT IS NOT CONFIRMED. THIS REPORTABLE EVENT WAS IDENTIFIED DURING A VOLUNTARY RETROSPECTIVE REVIEW OF ALL COMPLAINTS SINCE 2015 BY THE MANUFACTURER (DUTCH OPHTHALMIC RESEARCH CENTRE B.V.). DETAILS OF THIS ACTIVITY WERE DISCUSSED WITH CDRH OFFICE OF COMPLIANCE (B)(6) DURING A TELE-CONFERENCE ON (B)(6)2017. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. THIS COMPLAINT HAS NOW BEEN CLOSED. PLEASE NOTE THAT 2 MDRS SUBMITTED FOR THE 2 PARTS THAT WERE USED TOGETHER IN THE IMPLANT 1222074-2018-00052 AND 1222074-2018-00053.

    Description of Event or Problem · 1

    IT WAS REPORTED A PATIENT HAD A SCLERAL BUCKLE IMPLANTED IN RIGHT EYE ONE YEAR AGO. THE PATIENT REPORTEDLY HAD AN ALLERGIC REACTION ON THE SKIN SURROUNDING HER EYE AND WAS SEEN BY A DERMATOLOGIST. THE PATIENT WAS EVALUATED FOR A POSSIBLE ALLERGIC REACTION RELATED TO SILICONE. IT WAS REPORTED THE MD WANTS TO PERFORM AN ALLERGY TEST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    187679 SCLERAL BUCKLING PRODUCTS: STYLE 70, SILICONE SLEEVE SCLERAL BUCKLING PRODUCTS: STYLE 70, SILICONE SLEEVE HQX D.O.R.C DUTCH OPHTHALMIC INTERNATIONAL BV 161019 08717872014319

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention