MAUDE Adverse Event Report: COLOPLAST A/S PED FOLYSIL CATH 3ML CH08/5; SILICONE FOLEY CATHETER

Model Number	AA61081002
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
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
According to the available information, catheter has been inserted to a pediatric patient in emergency unit because of urinary retention.Patient was then transferred to pediatric ward, where the catheter had come out by itself the next morning.Catheter's balloon was tested and it was found out that the fluid doesn't stay inside the balloon, and that there was a hole on the catheter's balloon fluid canal.

• Brand Name: PED FOLYSIL CATH 3ML CH08/5
• Common Device Name: SILICONE FOLEY CATHETER
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebaek, da 3050 ; DA 3050
• MDR Report Key: 5555815
• Report Number: 9610711-2016-00012
• Device Sequence Number: 557014
• Product Code: EZL
• UDI-Device Identifier: 03600040126974
• UDI-Public: 03600040126974
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• PMA/510(K) Number: K013174
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/01/2016

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: AA61081002
• Device Catalogue Number: AA61081002
• Device Lot Number: 12071826
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/16/2016
• Initial Report FDA Received Date: 04/07/2016
• 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: Required Intervention