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

Model Number 412011

Device Problem Failure To Adhere Or Bond (1031)

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

Event Date 08/18/2016

Event Type  malfunction  

Manufacturer Narrative

Based on the available information, this event is deemed to be a reportable malfunction.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 no additional patient/event details have been provided to date.Should additional information become available a follow-up report will be submitted.(b)(4).

Event Description

It was reported the dressing was applied to knee replacement incision on surgery date (b)(6) 2016.The end user had what was described as a large amount of drainage from the incision which caused the dressing to lift from the skin.The hydrofiber separated from the hydrocolloid to the end of the dressing that lifted from the skin on (b)(6) 2016.The end user was seen in the doctors office at that time and the dressing was removed.A new dressing applied.No untoward effects to the end user was reported.

• Brand Name: AQUACEL AG SURGICALL HYDROFIBER DRESSING
• Type of Device: DRESSING, WOUND, DRUG
• Manufacturer (Section D): CONVATEC INC.; 211 american avenue; greensboro NC 27409
• Manufacturer Contact: jeanette johnson ; 7900 triad center drive; suite 400; greensboro, NC 27409 ; 3365424681
• MDR Report Key: 5940744
• MDR Text Key: 54410740
• Report Number: 1049092-2016-00394
• Device Sequence Number: 1
• Product Code: FRO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K091034
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 08/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 412011
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/19/2016
• 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