BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GNP EYE DROP SOL 0.05%OP

    MDR report key: 10180021 · Received June 19, 2020

    Report

    Report Number
    MW5095142
    Event Type
    Malfunction
    Date Received
    June 19, 2020
    Date of Event
    June 16, 2020
    Report Date
    June 17, 2020
    Manufacturer
    UNKNOWN
    Product Code
    LPN
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    RECEIVED SEVERAL ORDERS OF OTC ITEMS FROM (B)(6) IN APRIL. UPON OPENING THE ITEMS EACH OF THEM HAD A NOXIOUS SMELL. CONSUMPTION OF THESE OTC ITEMS RESULTED IN HEADACHE, ABDOMINAL PAIN (POSSIBLY LIVER), LOWER BACK PAIN (POSSIBLY KIDNEYS), AND GENERALIZED PAIN AND DISCOMFORT. THE EYE DROPS ALSO RESULTED IN A BURNING SENSATION. DUE TO THE LARGE LIST I AM UNABLE TO ADD ALL THE PRODUCTS BUT THEY ARE LISTED BELOW: ALL OF THESE ITEMS APPEARED TO HAVE BEEN CONTAMINATED, SHIPPED FROM (B)(6) OTC: PAIN RELIEVER TAB PLUS, GNP EYE DROP SOL 0.05%OP, BIOTIN GUMMIES, CALCIUM CITRATE+VITAMIN D, SENTRY MULTIVIT/MINERAL SUPPL, EYE CARE VITAMINS, FERROUS SULFATE 5GR TAB, FOLIC ACID 800 MCG, GLUCOSAMINE CHONDROITIN TRIPLE ST, GUMMY VITAMIN C 250MG, LIQUID IRON 220MG/5ML, MAGNESIUM OXIDE 400MG, OMEGA-3 FISH OIL 1000 MG SOFTGELS, ONE A DAY WOMEN'S MULTIVITAMIN, MSM 1000MG, RENA-VITE VITAMINS, URINARY PAIN RELIEF TABS, BLADDER CONTROL PADS, GNP ALL DAY TAB ALLERGY, DAYTIME PE COUGH AND COLD, MUCUS RELIEF TAB 400MG, LORATADINE TAB 10MG, COENZYME Q-10 100 MG SOFTGELS, OMEGA-3 FISH OIL 1000 MG SOFTGELS, VITAMIN D 50 B-COMPLEX WITH B-12, NAPROXEN 220MG TAB, ASPIRIN EC TAB 325MG, IBUPROFEN TAB 200MG, GUMMY VITAMIN C 250MG, VITAMIN-C 500MG, FOLIC ACID 800 MCG, POTASSIUM GLUCONATE 595MG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    638392 GNP EYE DROP SOL 0.05%OP ACCESSORIES, SOFT LENS PRODUCTS LPN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR