BEUDAMED
    FDA Adverse Event Other Summary report: N

    CLOSURE TAPE USED TO SECURE VAG DELIVERY PACK

    MDR report key: 1120703 · Received August 14, 2008

    Report

    Report Number
    1055954-2008-00001
    Event Type
    Other
    Date Received
    August 14, 2008
    Date of Event
    June 26, 2008
    Report Date
    August 8, 2008
    Manufacturer
    SRI SURGICAL
    Product Code
    FRG
    Removal / Correction Number
    1054451-07/14/08-002-C
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DURING EVAL, NEW COMPONENT RESEARCH QUESTIONAIRES WERE OBTAINED FROM THE MFR OF ALL COMPONENTS CONTAINED IN THE VAGINAL DELIVERY PACK. SRI DISCOVERED THAT THE MFR OF THE PACK CLOSURE LABEL USED TO SECURE THE OUTSIDE OF THE PACK CHANGED THE ADHESIVE TO A COMPOUND CONTAINING NATURAL RUBBER LATEX WITHOUT NOTIFYING OR OBTAINING SRI'S APPROVAL. EVAL SUMMARY: IT HAS BEEN DETERMINED THAT THE PACK CLOSURE TAPE UTILIZED TO SECURE THE OUTER WRAP OF CERTAIN SRI DISPOSABLE ACCESSORY PACKS CONTAINS "NATURAL RUBBER LATEX". THIS IS A LABELING ISSUE. 21 CFR 801 REQUIRES THAT ALL COMPONENTS THAT ARE INCLUDED IN OUR PACKS THAT CONTAIN LATEX BE CLEARLY IDENTIFIED ON THE LABEL. AS A RESULT OF OUR DISCOVERY THAT THIS ITEM CONTAINS LATEX, THE PACK CLOSURE LABEL, BY DEFAULT, IS INCORRECTLY IDENTIFIED ON THE PACK LABEL (THE PACK LABEL DOES NOT INDICATE THAT THE PACK CLOSURE TAPE CONTAINS LATEX). THIS IS A LABELING VIOLATION PER THE FDA AND REQUIRES SRI TO TAKE IMMEDIATE ACTION TO CORRECT.

    Description of Event or Problem · 1

    A NURSE REPORTED AN ALLERGIC REACTION AFTER OPENING ONE OF SRI SURGICAL DISPOSABLE ACCESSORY PACKS. THE AFFECTED NURSE REPORTED A RASH, ITCHING AND HIVES ON HER ARMS, CHEST AND FACE AND SHORTNESS OF BREATH. SHE WAS SENT TO EMPLOYEE HEALTH AND GIVEN OXYGEN. THE REACTION SUBSIDED AFTER APPROX FIVE MINS AFTER BEING AWAY FROM THE PACK. THE NURSE BELIEVED IT TO BE CAUSED BY A "FILM" ON THE DISPOSABLE WRAP THAT WRAPS AROUND THE PACK TO HOLD IT TOGETHER. THE NURSE INVOLVED IS REPORTEDLY ALLERGIC TO LATEX. THIS PARTICULAR DISPOSABLE ACCESSORY PACK IS LABELED AS LATEX FREE. ALL COMPONENT FILES WERE REVIEWED AND VERIFIED TO BE LATEX FREE. AS PART OF THE INVESTIGATION, SRI SURGICAL OBTAINED NEW COMPONENT RESEARCH QUESTIONAIRES FROM EACH COMPONENT MFR. ON 07/11/2008, SRI SURGICAL BECAME AWARE THAT THE MFR OF THE PACK CLOSURE LABEL USED TO SECURE THE OUTER WRAP OF CERTAIN STERILE DISPOSABLE ACCESSORY PACKS CHANGED THE ADHESIVE TO A COMPOUND CONTAINING NATURAL RUBBER LATEX WITHOUT NOTIFYING OR OBTAINING SRI'S APPROVAL. AS A RESULT, THE ITEM WAS NOT CORRECTLY IDENTIFIED ON THE PACK LABEL AS CONTAINING LATEX. ON 07/11/2008, SRI BECAME AWARE THAT THE ALLERGIC REACTION WAS LIKELY DUE TO THE PACK CLOSURE LABEL. SRI SURGICAL INITIATED A VOLUNTARY MEDICAL DEVICE FIELD CORRECTION WITH THE FDA AND ITS CUSTOMERS ON JULY 16, 2008.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CLOSURE TAPE USED TO SECURE VAG DELIVERY PACK SRI SURGICAL DISPOSABLE ACCESSORY PACK FRG SRI SURGICAL LD0694C 58061

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Other