MAUDE Adverse Event Report: COLOPLAST A/S FOLYSIL TIEMANN CATH 5/15ML; SILICONE FOLEY CATHETER

Model Number	AA63161002
Health Effect - Clinical Code	Pain (1994)
Date of Event	02/13/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Without the benefit of examination and testing, coloplast is precluded from commenting on the condition of the device or the cause of the occurrence.Should additional facts prompt us to alter or supplement any information of conclusions contained in the original mdr or in any prior supplemental reports, a follow-up report will be submitted.
Event or Problem Description
End user began experience a high level of bladder pain.He sought treatment at the er.The cause of the pain was rupture of the balloon.The ic is replaced every 4 weeks at his urologists' office.The ic was due to be replaced on tuesday (b)(6) 2017.Upon examination at the er, the nurse attempted to reduce the balloon, but since it ruptured, there was nothing to reduce.The catheter was removed and replaced with a new one.The er department conducted "a scan" (ultrasound?) and no evidence of material was noted.Patient was discharged after 4 hours.

• Brand Name: FOLYSIL TIEMANN CATH 5/15ML
• Common Device Name: SILICONE FOLEY CATHETER
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebaek, da 3050 ; DA 3050
• MDR Report Key: 6367968
• Report Number: 9610711-2017-00005
• Device Sequence Number: 737381
• Product Code: EZL
• UDI-Device Identifier: 03600040128770
• UDI-Public: 03600040128770
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K013174
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: AA63161002
• Device Catalogue Number: AA63161002
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/16/2017
• Initial Report FDA Received Date: 03/01/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other