MAUDE Adverse Event Report: COLOPLAST A/S FOLYSIL OVERGUIDE 5/15ML CH16; SILICONE FOLEY CATHETER

Model Number	AA64161002
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Serious Injury
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, balloon bursts after several hours indwelling.The patient had bladder stones.Dr.Confirmed no particles remained in bladder.
Additional Manufacturer Narrative
This follow-up mdr was created to document the evaluation of the returned device: evaluation of the returned device confirmed the balloon bursts.From experience, silicone balloon burst issue could come from various causes.In this cases we can not identify any specific root cause as unsufficient information has been provided to do so.Based on the above, this complaint is confirmed as a product defect.Checking the quality databases revealed that issue of silicone balloon is known.No other corrective action will be implemented as the specific trend for balloon issue and this product family is considered acceptable.

• Brand Name: FOLYSIL OVERGUIDE 5/15ML CH16
• Common Device Name: SILICONE FOLEY CATHETER
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebaek, 3050 ; DA 3050
• MDR Report Key: 7313685
• Report Number: 9610711-2018-00005
• Device Sequence Number: 110155
• Product Code: EZL
• UDI-Device Identifier: 03600040129975
• UDI-Public: 03600040129975
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K013174
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/19/2018

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: AA64161002
• Device Catalogue Number: AA64161002
• Device Lot Number: 5711695
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/20/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/06/2018
• Supplement Date Received by Manufacturer: 02/06/2018
• Initial Report FDA Received Date: 03/05/2018
• Supplement Report FDA Received Date: 03/21/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1