MAUDE Adverse Event Report: COLOPLAST A/S FOLYSILX-TRA SGL OPEN END CH14; INDWELLING CATHETER

Model Number AA8C141002

Device Problem Burst Container or Vessel (1074)

Patient Problem Skin Irritation (2076)

Event Date 07/23/2015

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 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 Description

According to the information received, the patient's balloon was not inflating correctly.Additionally, one burst and another snapped.This caused irritation to patients skin.The incident occurred in patients home, so customer rang to inform health care professional.

• Brand Name: FOLYSILX-TRA SGL OPEN END CH14
• Type of Device: INDWELLING CATHETER
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebaek, 3050 ; DA 3050
• Manufacturer (Section G): COLOPLAST A/S MANUFACTURING FRANCE SAS; 9 avenue edmond rostand; sarlat la canéda, 24206 ; FR 24206
• Manufacturer Contact: brianna macdonald ; 1601 w river rd n; minneapolis, MN 55411 ; 6123377800
• MDR Report Key: 5046559
• MDR Text Key: 25363585
• Report Number: 9610711-2015-00029
• Device Sequence Number: 1
• Product Code: EZL
• Combination Product (y/n): N
• PMA/PMN Number: K013174
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature,other
• Reporter Occupation: Other
• Report Date: 09/02/2015

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
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/28/2018
• Device Model Number: AA8C141002
• Device Catalogue Number: AA8C141002
• Device Lot Number: 4507924
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/01/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/29/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other