BEUDAMED
    FDA Adverse Event Other Summary report: N

    SORBSAN (WOUND DRESSING)

    MDR report key: 799258 · Received December 20, 2006

    Report

    Report Number
    8010113-2006-00001
    Event Type
    Other
    Date Received
    December 20, 2006
    Date of Event
    August 10, 2005
    Report Date
    December 14, 2006
    Manufacturer
    UNOMEDICAL, LTD.
    Product Code
    MGQ
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    UNOMEDICAL HAS REVIEWED THE BIOCOMPATIBILITY DATA AND HAVE HAD AN EVALUATION PERFORMED BY THE COMPANY'S CONSULTANT PHYSICIAN. UNOMEDICAL HAS ALSO REVIEWED THE COMPLAINT FILE TO ESTABLISH THE COMPLAINT RATIO WHICH RELATES TO ALLERGIES ASSOCIATED WITH THE SORBSAN PRODUCT. A REVIEW WAS ALSO PERFORMED ON THE INSTRUCTIONS FOR USE IN RESPECT TO THIS ADVERSE EVENT.

    Description of Event or Problem · 1

    CONVERSATION: THE PT REPORTEDLY BEGAN USING THE PRODUCT IN 2005. THE NURSE PRACTITIONER REPORTED THAT THE PRODUCT WAS APPLIED TO THE GRANULOMA AROUND THE PATIENT'S G-TUBE SITE. WITHIN 10 MINUTES OF APPLICATION, THE PATIENT'S MOTHER REPORTED THAT THE AREA HAD BECOME RED AND IRRITATED. THE PRODUCT WAS REMOVED AFTER BEING APPLIED FOR APPROXIMATELY 30 MINUTES. THE NURSE PRACTITIONER INFORMED ME THAT WITHIN 24 HOURS THE AREA OF THE APPLICATION SITE BECAME NECROTIC. THE PATIENT WAS ADMITTED TO THE HOSPITAL 3 DAYS LATER. SHE STATED THAT THE G-TUBE IS NON FUNCTIONING AND THE PATIENT HAS HAD A BROVIAC CATHETER PLACED AND IS BEING STARTED ON HYPERALIMENTATION. THE PATIENT REMAINS HOSPITALIZED. THE NURSE PRACTITIONER WAS UNABLE TO PROVIDE INFORMATION REGARDING THE TREATMENT, IF ANY, GIVEN TO THE SITE. INFORMATION REGARDING MEDICAL HISTORY AND CONCOMITANT MEDICATIONS WAS PROVIDED. THE NURSE PRACTITIONER WAS TRANSFERRED FOR ADDITIONAL INFORMATION REGARDING THE PRODUCT. PHYSICIAN CONTACT INFORMATION WAS PROVIDED AND SHE'S WILLING TO COMPLETE AND RETURN A PRODUCT EXPERIENCE FORM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SORBSAN (WOUND DRESSING) SORBSAN MGQ UNOMEDICAL, LTD. NOT KNOWN NOT KNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 4 YR Hospitalization CHOLESTEROL| SILVER NITRATE| FLUTICASONE| GLYCOPYRRONIUM BROMIDE| HYDROCHLORIDE| TRIAMCINOLONE| PROPIONATE MOMETASONE FUROATE| IRON| RANITIDINE