BEUDAMED
    FDA Adverse Event Other Summary report: N

    GEL-E DONUT - SMALL

    MDR report key: 2992731 · Received March 1, 2013

    Report

    Report Number
    3007056120-2013-00001
    Event Type
    Other
    Date Received
    March 1, 2013
    Date of Event
    December 25, 2012
    Report Date
    February 7, 2013
    Manufacturer
    CHILDRENS MEDICAL VENTURES
    Product Code
    CCX
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINT ISSUE ALLEGED BY THE CUSTOMER OF A GEL PILLOW INSIDE OF THE PACKAGING HAVING BLACK MOLD WAS NOT ABLE TO CONFIRMED BECAUSE THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION. THE GEL PRODUCTS ARE INTENDED TO PROVIDE SUPPORT FOR INFANTS IN A HOSPITAL ENVIRONMENT AND A CAREGIVER IS TO BE PRESENT DURING USE. NORMAL USE WILL CONFORM TO ACCEPTED MEDICAL PRACTICE AND TO THE LABELING INSTRUCTIONS. THE INSTRUCTIONS FOR USE (IFU) STATE TO WIPE DOWN THE GEL-E DONUT WITH AN ANTIBACTERIAL AGENT AND TO COVER BEFORE USE. ALTHOUGH THE REPORTED PRODUCT ISSUE COULD NOT BE SUBSTANTIATED, BASED ON THE AVAILABLE EVIDENCE, CHMV HAS DETERMINED THAT IF THE REPORTED PRODUCT ISSUE WERE TO OCCUR, THERE IS NO INCREASED RISK TO THE PATIENT OF END USER. THE ISSUE WAS ANTICIPATED IN THE RISK ANALYSIS AND THUSLY ADDRESSED ACCORDINGLY IN THE PRODUCT LABELING. CHMV HAS DETERMINED THAT NO FURTHER INVESTIGATION ACTIVITY INTO THE REPORTED ISSUE IS REQUIRED. IF THE PRODUCT IS RETURNED AND THE EVALUATION CONCLUSIONS DIFFER FROM THE ONES DETERMINED IN THIS REPORT, A FOLLOW-UP ADDITIONAL INFORMATION REPORT WILL BE FILED.

    Description of Event or Problem · 1

    CHILDREN'S MEDICAL VENTURES (CHMV) RECEIVED MEDWATCH REPORT (B)(4) DETAILING A PRODUCT ISSUE ASSOCIATED WITH A GEL-E DONUT POSITIONING DEVICE. NO RESULTING EFFECT ON A PATIENT OR POTENTIAL USER HAS BEEN REPORTED. THE DEVICE WAS REPORTEDLY NOT PUT INTO USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    89385 GEL-E DONUT - SMALL GEL-E DONUT CCX CHILDRENS MEDICAL VENTURES 92025-B

    Patients

    Seq Age Sex Outcome Treatment
    1