MAUDE Adverse Event Report: UNOMEDICAL S.R.O. URINEMETER 4 SURE 2 L BAG; DEVICE, URINE FLOW RATE MEASURING, NON-ELECTRICAL, DISPOSABLE

Model Number UB6400

Device Problems Leak/Splash (1354); Defective Device (2588)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/27/2011

Event Type  malfunction  

Manufacturer Narrative

Initial emdr is being re-submitted per request of fda on 07-jun-2021.Convatec is submitting this report as a result of activities related to convatec remediation protocol 2015-001-pro and protocol 2015-002-pro.Convatec is submitting this report pursuant to the provisions of 21cfr part 803.Blank fields on this form indicate the information is unknown, unavailable or unchanged.Any additional information received regarding this event after filing this report will be filed on a supplemental report (medwatch 3500a).\evaluation conclusions are reflected in the codes.On 17-dec-2015, the following correction was identified: the report submitted on 07-nov-2015 with the patient identifier of (b)(6), had the incorrect manufacturers report number listed.The correct manufacturers report number should have been 3005778470-2015-30668.(b)(4).

Event Description

The complainant was unable to reset abdo pressure monitoring using this collection bag as the sample port got a hole in it from interlink connector or needle and leaked.So, the complainant was unable to use more than once without replacing the collection bag.Attempted a number of times and bag was replaced.

• Brand Name: URINEMETER 4 SURE 2 L BAG
• Type of Device: DEVICE, URINE FLOW RATE MEASURING, NON-ELECTRICAL, DISPOSABLE
• Manufacturer (Section D): UNOMEDICAL S.R.O.; priemyselny park 3; michalovce, 07101 ; LO 07101
• Manufacturer Contact: pamela meadows ; 7815 national service road; suite 600; greensboro, NC 27409 ; 3365424679
• MDR Report Key: 5312146
• MDR Text Key: 254627200
• Report Number: 3005778470-2015-30668
• Device Sequence Number: 1
• Product Code: FFG
• Combination Product (y/n): Y
• Reporter Country Code: AS
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/27/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: UB6400
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/27/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1