FDA Adverse Event Malfunction Summary report: N

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MDR report key: 2225753 · Received August 15, 2011

Report

Report Number
2225753
Event Type
Malfunction
Date Received
August 15, 2011
Date of Event
March 13, 2011
Report Date
April 4, 2011
Manufacturer
*
Product Code
OIB
Product Problem
Yes
Report Source
User Facility report
Reporter Location
AL, US

Narratives

Description of Event or Problem · 1

THE PLASTIC URINE COLLECTION CUPS CRACK AND BREAK, SPILLING THE URINE DURING TRANSPORT THROUGH THE TUBE SYSTEM.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 * URINE COLLECTION CUP OIB * * *

Patients

Seq Age Sex Outcome Treatment
1 *