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

Model Number	AA63121002
Health Effect - Clinical Code	Unspecified Infection (1930)
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
They were confronted with the impossibility of deflating the balloons foley.For one of the patient the consequences were important: increase of the duration of hospitalization, infection."the product information for the device was not available at the time of the complaint.Therefore, the item number above was used only to record the product type, but may not reflect the correct size.Additional information will be added, if it becomes available".

• 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: 6534923
• Report Number: 9610711-2017-00016
• Device Sequence Number: 746138
• Product Code: EZL
• UDI-Device Identifier: 03600040128510
• UDI-Public: 03600040128510
• 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: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 05/01/2017

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?: No
• Operator of Device: Health Professional
• Device Model Number: AA63121002
• Device Catalogue Number: AA63121002
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/09/2017
• Initial Report FDA Received Date: 05/01/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1