MAUDE Adverse Event Report: COLOPLAST A/S; SILICONE FOLEY CATHETER

Device Problems Migration or Expulsion of Device (1395); Device Operates Differently Than Expected (2913); Material Protrusion/Extrusion (2979)

Patient Problem Pain (1994)

Event Date 01/28/2018

Event Type  Injury  

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 Description

According to available information, the patient experienced severe pain and noticed much more of the rubber hose sticking out than normal.It was pushed back in quite a bit and the pain went away.The patient visited the er and they said it was a failure of the catheter.

Manufacturer Narrative

This follow-up mdr is created to document the conclusion of the evaluation and additional event information.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.In the description of the defect: "she put in 20cc of liquid to hold it in." that is not according with the ifu sh 2115 :inflate the balloon with sterile water to the volume indicated on the package label and for this product aa6116 (15cc) this defect can consider as misuse.Our clinical assessment concludes: urethral catheterization is a routine urological procedure but some complications may be associated with long term indwelling urethral catheters.This type of medical device must only be used by trained and experienced professionals.The incident described as catheter dislodgement associated with transient severe pain (relieved when the patient pushed the catheter back to the bladder) does not represent an immediate clinical risk for the patient.

• Type of Device: SILICONE FOLEY CATHETER
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebaek, 3050 ; DA 3050
• Manufacturer (Section G): COLOPLAST A/S MANUFACTURING FRANCE; 9 avenue edmond rostand; sarlat-la-caneda, 24206 ; FR 24206
• Manufacturer Contact: sarah o'gara ; 1601 west rivier road north; minneapolis, MN 55411 ; 6123578517
• MDR Report Key: 7293082
• MDR Text Key: 100831363
• Report Number: 9610711-2018-00004
• Device Sequence Number: 1
• Product Code: EZL
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 06/20/2018

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?: No
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/29/2018
• Initial Date FDA Received: 02/23/2018
• Supplement Dates Manufacturer Received: 01/29/2018
• Supplement Dates FDA Received: 06/22/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 66 YR