BEUDAMED
    FDA Adverse Event Other Summary report: N

    DURAPLUG EXTENDED WEAR PLUGS

    MDR report key: 2519762 · Received March 30, 2012

    Report

    Report Number
    2522801-2012-00003
    Event Type
    Other
    Date Received
    March 30, 2012
    Date of Event
    July 1, 2011
    Report Date
    March 30, 2012
    Manufacturer
    SURGICAL SPECIALTIES CORP., (DBA ANGIOTECH)
    Product Code
    LZU
    PMA / PMN Number
    K020882
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL USED DEVICE WAS NOT RETURNED FOR REVIEW. STERILE SAMPLES FROM THIS FINISHED GOOD LOT WERE NOT AVAILABLE FOR TESTING. METHOD: NO SAMPLES WERE RETURNED FOR REVIEW. THEREFORE NO EVALUATION WAS PERFORMED. RESULTS, CONCLUSIONS: NO SAMPLES WERE RETURNED FOR REVIEW. THEREFORE NO EVALUATION WAS PERFORMED. RELEVANT PORTIONS OF THE DEVICE HISTORY RECORD WAS REVIEWED AND NO CORRESPONDING ISSUES WERE IDENTIFIED DURING THE MANUFACTURING PROCESSES OR AT FINAL INSPECTION. THE STERILITY RECORDS CONFIRMED THAT ALL PRODUCT FROM THIS FINISHED GOOD LOT/LOAD WAS STERILE WHEN RELEASED. THERE WERE NO OTHER EVENTS REPORTED FOR THIS PARTICULAR FINISHED GOOD LOT AND NO SIMILAR EVENTS WERE REPORTED FOR THE PCL EXTENDED WEAR PLUGS. THE GELLANSERTS ARE NOT FLUSHED FROM THE CANAL PRIOR TO INSERTING THE EXTENDED WEAR DEVICES. THEREFORE, THE ROOT CAUSE FOR THE REPORTED POST-OPERATIVE REACTION CAN NOT BE DETERMINED AT THIS TIME. (B)(4), ITEM # 0077, DURAPLUG PCL EXTENDED WEAR PLUGS, LOT M446690.

    Description of Event or Problem · 1

    THE DATE OF EVENT IS ESTIMATED. THE DISTRIBUTOR REPORTED THAT A DOCTOR HAD A PATIENT PRESENT WITH SECRETION IN THE CANALICULUS AND REDNESS OF THE EYE TWO (2) MONTHS POST INSERTION OF A 2.0MM X 3.0MM PCL PUNCTUM PLUG. THE PATIENT WAS TREATED WITH ANTIBIOTICS AND AN ANTI-INFLAMMATORY DRUG WITHOUT IMPROVEMENT. TWO (2) MONTHS LATER THE PATIENT REQUIRED A CANALICULOTOMY, DEBRIDEMENT AND REMOVAL OF THE FOREIGN BODY. THE FOREIGN BODY WAS ANALYZED AND SHOWED A 2MM X 2MM MUCOID MATERIAL WITH FRAGMENTS OF DENSE, ACELLULAR AND EOSINOPHILICUM MATERIAL AND ALSO RED BLOOD CELLS AND BACTERIAL COLONIES. THE PATIENT RESPONDED WELL FOLLOWING THIS PROCEDURE. A TEMPORARY DEVICE (0.3MM X 1.5MM GELLANSERT) WAS INSERTED PRIOR TO INSERTING THE PCL PLUG. THE PATIENT HAD NO PRE-EXISTED MEDICAL CONDITIONS OR ALLERGIES THAT WOULD HAVE AFFECTED THE HEALING PROCESS OR CONTRIBUTED TO THE REACTION. THE SURGEON STATED THAT THIS WAS THE FIRST REACTION HE HAS SEEN FOLLOWING PLUG IMPLANTATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DURAPLUG EXTENDED WEAR PLUGS PCL PLUG LZU SURGICAL SPECIALTIES CORP., (DBA ANGIOTECH) 0077 M446690

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention