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

Model Number	AA63141002
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Information (3190)
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.Once our evaluation is complete, a follow-up report will be submitted.
Event or Problem Description
According to the available information, the balloon fell off during indwelling due to balloon burst, the physician confirmed no residue or particle remains in patient's bladder, replaced with new catheter immediately.No clinical consequences reported.
Additional Manufacturer Narrative
This follow-up mdr is created to document the conclusion of the investigation: after receiving this complaint, we could not search for other complaint as the lot number is not available.From experience, silicone balloon burst 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.This complaint will be used for trend analysis.No other corrective action will be implemented as the specific trend for balloon deflating and this product family has an average which is considered acceptable as per the threshold.

• Brand Name: FOLYSIL TIEMANN CATH 5/15ML
• Common Device Name: SILICONE FOLEY CATHETER
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebaek, 3050 ; DA 3050
• MDR Report Key: 8248323
• Report Number: 9610711-2019-00002
• Device Sequence Number: 16539764
• Product Code: EZL
• UDI-Device Identifier: 03600040128640
• UDI-Public: 03600040128640
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/01/2019

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: AA63141002
• Device Catalogue Number: AA6314
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/18/2018
• Supplement Date Received by Manufacturer: 12/18/2018
• Initial Report FDA Received Date: 01/15/2019
• Supplement Report FDA Received Date: 02/12/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1