MAUDE Adverse Event Report: CONVATEC LIMITED FLEXI-TRAK (LARGE) ANCHORING DEVICE 50 PACK; ACCESSORIES, CATHETER

Model Number 37449

Device Problems Failure To Adhere Or Bond (1031); Device Dislodged or Dislocated (2923)

Patient Problem Vaginal Mucosa Damage (2124)

Event Date 10/28/2016

Event Type  malfunction  

Manufacturer Narrative

Based on the available information, this event is deemed to be a reportable malfunction and a serious patient injury.No lot number is available.A detailed investigation or batch review cannot be conducted.Therefore, this evaluation will be closed.This issue will be monitored through the post market product monitoring review process.Additional details have been requested but not provided to date.Should additional information become available, a follow-up report will be submitted.A separate report has been submitted to cover the additional device reported.(b)(4).

Event Description

Complaint received from a nurse reporting that on two (2) separate incidences when the anchoring device did not adhere well to the skin, it caused the catheter to move and tear the urethral mucosal tissue.No further information was provided.

Manufacturer Narrative

This supplemental report is being submitted to correct section (type of reportable event) to malfunction which was submitted incorrectly in error for the initial mdr (mfr report# 1000317571-2016-00109) on november 28, 2016.No additional patient/event details have been provided to date.Should additional information become available, a follow-up report will be submitted.(b)(4).

• Brand Name: FLEXI-TRAK (LARGE) ANCHORING DEVICE 50 PACK
• Type of Device: ACCESSORIES, CATHETER
• Manufacturer (Section D): CONVATEC LIMITED; first avenue; deeside industrial park; deeside, flintshire CH52N U; UK CH52NU
• Manufacturer Contact: jeanette johnson ; 7900 triad center drive; suite 400; greensboro, NC 27409 ; 3365424681
• MDR Report Key: 6130591
• MDR Text Key: 60988957
• Report Number: 1000317571-2016-00109
• Device Sequence Number: 1
• Product Code: KGZ
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 10/28/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/28/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 37449
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/09/2016
• 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: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other