MAUDE Adverse Event Report: CONVATEC LIMITED, AQUACEL AG DRS 2X45CM; DRESSING, WOUND, DRUG

Model Number 403712

Device Problems Difficult to Open or Remove Packaging Material (2922); Material Integrity Problem (2978); Packaging Problem (3007)

Patient Problem No Patient Involvement (2645)

Event Date 01/28/2014

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 that the product is pinched at the compressed part of the individual package seam, which causes difficulty for taking out the product.Also the width of the product is not even.

• Brand Name: AQUACEL AG DRS 2X45CM
• Type of Device: DRESSING, WOUND, DRUG
• Manufacturer (Section D): CONVATEC LIMITED,; first ave; deeside industrial park; deeside, flintshire
• Manufacturer Contact: jeanette johnson ; 211 american ave; greensboro, NC 27409 ; 3362973009
• MDR Report Key: 5124539
• MDR Text Key: 27376342
• Report Number: 1000317571-2015-30199
• Device Sequence Number: 1
• Product Code: FRO
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K063271
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Health Professional
• 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: No Information
• Device Expiration Date: 09/01/2016
• Device Model Number: 403712
• Device Lot Number: 3J00171
• 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: 09/10/2013
• 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