MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC DISPOSABLE URINAL

Catalog Number NOVA20235

Device Problems Air Leak (1008); Image Display Error/Artifact (1304)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/02/2014

Event Type  malfunction  

Event Description

Unable to the read numbers/amount on plastic urinals.The plastic is defective, with bubbles and swiggles in the plastic where it should be smooth.As a result, staff are unable to read the amount of urine in the urinals.There are 48 devices per case.All devices in the case are affected.
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manufacturer response for urinal, (brand not provided) (per site reporter).
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the distributor field representative was notified of the issue.

• Brand Name: DISPOSABLE URINAL
• Type of Device: URINAL
• Manufacturer (Section D): MEDLINE INDUSTRIES INC; 1 medline place; mundelein IL 60060
• MDR Report Key: 4180285
• MDR Text Key: 5159938
• Report Number: 4180285
• Device Sequence Number: 1
• Product Code: FNP
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 09/30/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Invalid Data
• Device Catalogue Number: NOVA20235
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/30/2014
• Event Location: Hospital
• Date Report to Manufacturer: 10/17/2014
• Patient Sequence Number: 1