BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CATARACT PACK

    MDR report key: 138759 · Received December 17, 1997

    Report

    Report Number
    1423507-1997-00279
    Event Type
    Malfunction
    Date Received
    December 17, 1997
    Date of Event
    December 1, 1997
    Report Date
    December 17, 1997
    Manufacturer
    ALLEGIANCE HEALTHCARE CORP.
    Product Code
    FRL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    ALLEGIANCE INVESTIGATION: DEVICE HISTORY RECORD REVIEW, SAMPLE REVIEW NOTED FUZZ ON THE GOWNS AND TINY WHITE PARTICULATE IN THE EMESIS BASIN. SOME DEBRIS WAS FROM GOWNS - SOME COULD NOT BE IDENTIFIED. SUPPLIERS NOTIFIED FOR EVALUATION. MENTOR O & O INVESTIGATION: NUMEROUS ATTEMPTS WERE MADE TO OBTAIN A RESPONSE. NONE REC'D. CONVERTORS INVESTIGATION: THE GOWN MATERIAL CONSIST OF A SPUNLACED NONWOVEN FABRIC. THE SPUNLACED IS MADE OF POLYESTER FIBERS AND WOOD PULP. UNABLE TO IDENTIFY THE ROOT CAUSE FOR THE LINT, SAMPLES WERE FORWARDED TO THE NONWOVEN FABRIC SUPPLIER FOR REVIEW. SUPPLIER CONFIRMED THE PRESENCE OF SMALL PIECES OF POLYESTER EXTENDING FROM THE FABRIC. MEASUREMENTS VERIFIED ALL PROPERTIES TO BE WITHIN ONE SIGMA OF THEIR AIM. THIS INCIDENT WILL BE PUBLICIZED TO THEIR ORGANIZATION TO MAINTAIN PROCEDURES FOR IDENTIFICATION SEGREGATION, AND CORRECTION OF FABRIC WITH LOT ENTANGLEMENT.

    Description of Event or Problem · 1

    FOUR PIECES OF LINT FROM THE PACK COMPONENTS GOT INTO THE PT'S EYE DURING THE PROCEDURE. THE PHYSICIAN IRRIGATED THE EYE WITH SALINE WHICH REMOVED THE LINT PARTICULATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CATARACT PACK CATARACT PACK FRL ALLEGIANCE HEALTHCARE CORP. SEY57CTNEB 627159

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention