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

Model Number AA61181002

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Micturition Urgency (1871); Pain (1994)

Event Date 11/11/2016

Event Type  malfunction  

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 occurence.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.Not returned to manufacturer.

Event Description

According to the information received, patient feels pain at bladder with the catheter and urges to urinate but does not succeed.After withdrawal of the catheter, the patient immediately urinates 700 ml.

• Brand Name: SILIC FOLEY CATH 5/15ML /5
• Type of Device: SILICONE FOLEY CATHETER
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebaek, da 3050 ; DA 3050
• Manufacturer (Section G): COLOPLAST MANUFACTURING US, LLC; 1601 west river road north; minneapolis MN 55411
• Manufacturer Contact: christine buckvold ; 1601 west river road north; minneapolis, MN 55411 ; 6123024982
• MDR Report Key: 6249685
• MDR Text Key: 65217311
• Report Number: 9610711-2017-00001
• Device Sequence Number: 1
• Product Code: EZL
• UDI-Device Identifier: 03600040127605
• UDI-Public: 03600040127605
• Combination Product (y/n): N
• PMA/PMN Number: K013174
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial
• Report Date: 01/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: AA61181002
• Device Catalogue Number: AA61181002
• Device Lot Number: 5156559
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/21/2016
• Initial Date FDA Received: 01/13/2017
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention