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

Model Number	AA63161002
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Information (3190)
Date of Event	09/11/2018
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 or 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, the balloon burst.There were no clinical consequence.
Additional Manufacturer Narrative
This follow-up mdr is created to document the corrected type of reportable event, the additional date of the event, and the conclusion of the investigation.After receiving this complaint, we could not search for other complaint as the lot number is not available.Unfortunately we have not been given sufficient information to perform an investigation, and no sample available from the complainant.This complaint will be used for trend analysis.No corrective action will be implemented as the specific trend for balloon burst of this product family 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: 8143614
• Report Number: 9610711-2018-00020
• Device Sequence Number: 11240466
• Product Code: EZL
• UDI-Device Identifier: 03600040128770
• UDI-Public: 03600040128770
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/04/2019

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: AA63161002
• Device Catalogue Number: AA6316
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/08/2018
• Supplement Date Received by Manufacturer: 11/08/2018
• Initial Report FDA Received Date: 12/07/2018
• Supplement Report FDA Received Date: 03/08/2019
• Patient Sequence Number: 1