UNOMETER SAFETI 150CM 2L (1/14)
Received Dec 19, 2013 · Event occurred Nov 21, 2013
Report 3007966929-2013-00023 · MDR key 3669806
Device
Generic name
Device, Urine Flow Rate Measuring
Manufacturer
Unomedical Ltd.Model number
158101210190Catalog number
158101210190
Lot number
655101
Product problems
- Detachment Of Device Component
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED A REPORTABLE MALFUNCTION. THERE WERE NO REPORTS OF A PT BEING HARMED AS A RESULT OF THIS MALFUNCTION. IT IS REPORTED THAT THIS ISSUE OCCURRED TO THE PRODUCT EVALUATION SAMPLE. NO ADDITIONAL PT/EVENT DETAILS HAVE BEEN PROVIDED TO DATE. A RETURN SAMPLE FOR EVALUATION IS NOT EXPECTED. SHOULD ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.
Description of Event or Problem
INFORMATION RECEIVED VIA COMPLAINT FORM IS INDICATED AS FOLLOWS: SALES REPRESENTATIVE STATED THAT THE PORT (KOMBIKOM) THAT CONNECTS TO THE BLADDER CATHETER WAS DETACHED.