BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RENU SENSITIVE MULTI-PURPOSE SOLUTION

    MDR report key: 3131402 · Received May 13, 2013

    Report

    Report Number
    1313525-2013-00006
    Event Type
    Injury
    Date Received
    May 13, 2013
    Date of Event
    September 29, 2012
    Report Date
    April 16, 2013
    Manufacturer
    BAUSCH & LOMB
    Product Code
    LPN
    PMA / PMN Number
    P860023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR EVALUATION AND THE LOT NUMBER INFORMATION IS UNKNOWN. MEDICAL DOCUMENTATION HAS NOT BEEN RECEIVED. BASED ON ALL INFORMATION, NO CAUSAL FACTORS CAN BE DETERMINED AND NO CONCLUSION CAN BE DRAWN.

    Description of Event or Problem · 1

    ATTORNEY REPORTED CLAIMANT WAS ADMITTED TO EMERGENCY ROOM AFTER SUFFERING PAIN, REDNESS, BLURRY VISION, DISCHARGE, SWELLING, AND SENSITIVITY TO LIGHT. CLAIMANT WAS DIAGNOSED WITH A CORNEAL ULCER WITH POSSIBLE ENDOPHTHALMITIS AND PANOPHTHALMITIS. CLAIMANT WAS TREATED WITH VARIOUS ANTIBIOTICS INCLUDING TOPICAL AND INTRAVENOUS WHICH WERE ADMINISTERED BY THE HOSPITAL ON A FREQUENT REGIMEN AND A PARS PLANA VITRECTOMY WAS PERFORMED. CLAIMANT'S VISION WAS NOT PRESERVED AND IS NOW LEGALLY BLIND IN RIGHT EYE. MEDICAL DOCUMENTATION HAS NOT BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    211884 RENU SENSITIVE MULTI-PURPOSE SOLUTION LPN BAUSCH & LOMB

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Disability