MAUDE Adverse Event Report: CONVATEC, INC. AQUACEL AG FOAM HYDROFIBER DRESSING; DRESSING, WOUND, DRUG

Model Number 420805

Device Problem Failure To Adhere Or Bond (1031)

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

Event Type  malfunction  

Manufacturer Narrative

Based on the available information, this event is deemed to be a reportable malfunction.No additional patient/event details have been provided to date.Should additional information become available a follow-up report will be submitted.Note: there were reportedly (b)(4) devices affected by this issue.A separate fda form 3500a or its electronic equivalent has been submitted for each device.Date of event: (b)(6) 2015.(b)(4).

Event Description

It was reported that the silicone adhesive border of the dressing did not adhere during use.The dressing came off after 1 day of wear.The dressing was removed and replaced.No patient complications were reported as a result of this event.

Manufacturer Narrative

Additional information was received on october 30, 2015.This issue was investigated by confirming the silicone trilaminate, the skin contact material, used in this lot of product was certified meeting the requirements of convatec.Confirming the lot of product was sterilization certified; and referencing summary of health data for dow corning® mg soft skin adhesive.All manufacturing, materials, and sterilization process were compliant to requirements.No previous investigations are available.After the detailed batch review, no discrepancies (including non-conformances/deviations) were found.There is not enough information to conclude the product did not meet specification and perform as intended.Product monitoring reviews will monitor for product trends if this issue were to reoccur.No further actions are required, and the complaint will be closed.(b)(4).

• Brand Name: AQUACEL AG FOAM HYDROFIBER DRESSING
• Type of Device: DRESSING, WOUND, DRUG
• Manufacturer (Section D): CONVATEC, INC.; 211 american avenue; greensboro NC 27409
• Manufacturer (Section G): CONVATEC, INC.; 211 american avenue; greensboro NC 27409
• Manufacturer Contact: jeanette johnson ; 7900 triad center drive; suite 400; greensboro, NC 27409 ; 3362973009
• MDR Report Key: 5150619
• MDR Text Key: 28303812
• Report Number: 1049092-2015-00605
• Device Sequence Number: 1
• Product Code: FRO
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K123481
• 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: 09/17/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/05/2017
• Device Model Number: 420805
• Device Lot Number: 2381347
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/30/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/06/2015
• 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