MAUDE Adverse Event Report: WEBTEC CONVERTING, LLC AQUACEL AG 8X7CM; DRESSING, WOUND, DRUG

Device Problem Failure To Adhere Or Bond (1031)

Patient Problem Skin Inflammation (2443)

Event Type  malfunction  

Manufacturer Narrative

Convatec is submitting this report as a result of activities related to convatec remediation protocol 2015-001-pro and protocol 2015-002-pro.Convatec is submitting this report pursuant to the provisions of 21cfr part 803.Any additional information received regarding this event after filing this report will be filed on a supplemental report (medwatch 3500a).

Event Description

The nurse reported using a sacral 8x7 inch aquacel ag foam adhesive dressing on a patient and it rolled up and caused this particular patient a rash under the adhesive.

• Brand Name: AQUACEL AG 8X7CM
• Type of Device: DRESSING, WOUND, DRUG
• 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: 5103953
• MDR Text Key: 26758389
• Report Number: 2320643-2015-30256
• Device Sequence Number: 1
• Product Code: FRO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K123481
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Nurse
• Report Date: 12/27/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/25/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• 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
• 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