BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDI-JECT

    MDR report key: 115630 · Received August 18, 1997

    Report

    Report Number
    MW4001982
    Event Type
    Injury
    Date Received
    August 18, 1997
    Report Date
    August 14, 1997
    Manufacturer
    MEDI-JECT CORP.
    Product Code
    KZE
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NJ, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    TIP OF NEEDLELESS SYRINGE "EXPLODED" AND CUT RPTR'S 11 YEAR OLD SON AS HE WAS INJECTING INSULIN ON JUNE 24TH. COMPLAINANT STATED THAT SHE COULD NOT DETERMINE HOW MUCH/IF ANY INSULIN HAD BEEN ADMINISTERED. MOTHER GAVE SON ANOTHER FULL DOSE, AND THERE WERE NO COMPLICATIONS. COMPLAINANT HAD ORDERED THE PRODUCT BY MAIL AND BEGAN TO USE IT ON JUNE 1ST. SON WAS INJECTING HIMSELF, AS RPTR INDICATED THAT WAS THE REASON FOR PURCHASING THIS DEVICE. HE PRACTICED FOR ABOUT A WEEK+ WITH SALINE INJECTIONS. MOTHER THEN CHANGED THE "NEEDLE" ON JUNE 10TH WHEN SON BEGAN TO USE REAL INSULIN. HE WAS USING HIS SECOND "NEEDLE" ON THE 24TH WHEN THERE WAS A LOUD POP AND THE END BROKE, CUTTING THE BOY ON HIS BUTTOCK. MOTHER HAD GOTTEN A POOR RESPONSE FROM THE FIRM SO THEY WROTE A LETTER TO THE LOCAL PAPER'S CONSUMER REPORTER COLUMN. COMPLAINANT ALSO STATED THAT THEY WERE TOLD THEY NEEDED A PRESCRIPTION TO PURCHASE THE DEVICE. HOWEVER, MEDI-JECT HAS NEVER REQUESTED THAT PRESCRIPTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDI-JECT NEEDLE FREE SYRINGE KZE MEDI-JECT CORP. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *