BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RENU (UNKNOWN TYPE)

    MDR report key: 2872135 · Received December 4, 2012

    Report

    Report Number
    1313525-2012-00038
    Event Type
    Injury
    Date Received
    December 4, 2012
    Date of Event
    October 28, 2010
    Report Date
    November 8, 2012
    Manufacturer
    BAUSCH & LOMB
    Product Code
    LPL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED FOR EVALUATION. THE LOT NUMBER AND THE PRODUCT TYPE ARE UNKNOWN. MEDICAL DOCUMENTATION WAS NOT RECEIVED. BASED ON ALL INFORMATION, NO CAUSAL FACTORS CAN BE DETERMINED AND NO CONCLUSION CAN BE DRAWN.

    Description of Event or Problem · 1

    RECEIVED COMPLAINT ALLEGING PLAINTIFF USED "RENU EYE SOLUTION" AND WAS CAUSED TO SUSTAIN SERIOUS AND PERMANENT INJURIES THAT INCLUDE, BUT ARE NOT LIMITED TO, AN ULCER TO THE RIGHT EYE AND IMPAIRED VISION. MEDICAL DOCUMENTATION HAS NOT BEEN RECEIVED AND NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RENU (UNKNOWN TYPE) NONE LPL BAUSCH & LOMB

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention