BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCLERAL BUCKLING PRODUCTS: STYLE 506, 3.0MM X 5.0MM OVAL SPONGE

    MDR report key: 7588927 · Received June 11, 2018

    Report

    Report Number
    1222074-2018-00174
    Event Type
    Injury
    Date Received
    June 11, 2018
    Date of Event
    February 19, 2018
    Report Date
    May 18, 2018
    Manufacturer
    DUTCH OPTHALMIC RESEARCH CENTER BV
    Product Code
    HQX
    UDI-DI
    08717872014630
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    THE USER FACILITY RETURNED COMPANION SAMPLES FROM THEIR STOCK FOR INSPECTION AND EVALUATION. VISUAL INSPECTION OF THE RETURNED UNOPENED ITEMS REVEALED NO ANOMALIES MEANING THAT THE INTEGRITY OF THE PACKAGING WAS NOT COMPROMISED. IN VIEW OF THE NATURE OF THE COMPLAINT, DORC REQUESTED THE EXTERNAL SUPPLIER OF THE PRODUCT TO REVIEW THE STERILE LOAD DOCUMENTATION (STERILITY TEST REPORTS AND BACTERIAL ENDOTOXIN TEST REPORTS) FOR THE LOT. SINCE NO DEVIATIONS WERE FOUND AND BECAUSE RESULTS WERE ALL WITHIN SPECIFICATION, IT MUST BE CONCLUDED THAT THE REPORTED INFECTION OCCURRED FROM A SOURCE OTHER THAN THE DEVICE. INFECTION IS A KNOWN COMPLICATION ASSOCIATED WITH ANY SURGERY AND IS REFERENCED IN THE INSTRUCTIONS FOR USE PROVIDED. THE STERILE LOAD DOCUMENTATION (STERILITY TEST REPORTS AND BACTERIAL ENDOTOXIN TEST REPORTS) HAS BEEN CHECKED AND NO DEVIATIONS WERE FOUND FOR THE LOT. AS REFERENCED IN THE PROVIDED IFU, LONG-TERM CLINICAL EXPERIENCE WITH USE OF SCLERAL BUCKLING PRODUCTS HAS SHOWN THAT THE RISK OF ADVERSE REACTIONS IS LOW AND ADVANTAGES CLEARLY OUTWEIGH ANY RISK FACTOR. AS WITH ALL SCLERAL BUCKLING PRODUCTS, THE POSSIBILITY OF EXTRUSION, EROSION OR INADVERTENT INFECTION EXISTS. AS RESULTS ON STERILITY OF THE PRODUCTS ARE WITHIN SPECIFICATIONS, D.O.R.C. CONCLUDES THE REPORTED INFECTION OCCURRED FROM A SOURCE OTHER THAN THE DEVICE. PLEASE NOTE THAT COMPLAINTS REGARDING DORC PRODUCT WILL CONTINUE TO BE MONITORED BY QA. YOUR COMPLAINT HAS NOT BEEN FOUND ACKNOWLEDGED. THE COMPLAINT IS NOW CLOSED.

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION HAS BEGUN. DEVICE HISTORY LOT REVIEW: THERE WAS NOTHING RELATIVE TO THIS COMPLAINT. THIS LOT MET BOTH STERILITY AND BACTERIAL ENDOTOXIN TEST REPORTS. RESULTS PASS REQUIREMENTS. UNUSED SAMPLES WERE RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    A USER FACILITY HAS REPORTED A SURGICAL REMOVAL OF AN EYE IMPLANT DUE TO INFECTION AND EXTRUSION. THE INITIAL DATE OF SURGERY FOR A RETINAL DETACHMENT OCCURRED ON (B)(6) 2017 FOR PLACEMENT OF THIS DEVICE. THEN ON (B)(6) 2018 THE SCLERAL BUCKLE WAS REMOVED FOR INFECTION AND EXTRUDING. THE DEVICE WAS REMOVED AND THEN SENT TO PATHOLOGY. IT WAS REPORTED PATHOLOGY REPORT INDICATED OCCASIONAL GRAM + COCCI. THE PATIENT WAS TREATED WITH ANTIBIOTICS. THE INCIDENT HAS FULLY RESOLVED. THE FACILITY HAS RETURNED UNUSED SAMPLES FROM THIS LOT FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    430488 SCLERAL BUCKLING PRODUCTS: STYLE 506, 3.0MM X 5.0MM OVAL SPONGE SCLERAL BUCKLING PRODUCTS: STYLE 506, 3.0MM X 5.0MM OVAL SPONGE HQX DUTCH OPTHALMIC RESEARCH CENTER BV 1007046 08717872014630

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention