MAUDE Adverse Event Report: WEBTEC CONVERTING, LLC AQUACEL® FOAM ADH 17.5X17.5; DRESSING,WOUND,HYDROPHILIC

Model Number 420621

Device Problems Failure To Adhere Or Bond (1031); Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

Convatec is submitting this report as a result of activities related to convatec remediation (b)(4).Any additional information received regarding this event after filing this report will be filed on a supplemental report (medwatch 3500a).

Event Description

Healthcare professional reports "at first adhered well, now for several weeks product loosens right after application.".

• Brand Name: AQUACEL® FOAM ADH 17.5X17.5
• Type of Device: DRESSING,WOUND,HYDROPHILIC
• Manufacturer (Section D): WEBTEC CONVERTING, LLC; 5900 middle view way; knoxville TN 37908
• Manufacturer Contact: jeanette johnson ; 211 american ave; greensboro, NC 27409 ; 3362973009
• MDR Report Key: 5124808
• MDR Text Key: 27387057
• Report Number: 2320643-2015-30205
• Device Sequence Number: 1
• Product Code: NAC
• Combination Product (y/n): N
• Reporter Country Code: FI
• 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
• Report Date: 02/27/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/02/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Expiration Date: 09/10/2018
• Device Model Number: 420621
• Device Lot Number: 2255974
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/27/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/11/2013
• 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