MAUDE Adverse Event Report: CONVATEC LIMITED AQUACEL AG EXTRA DRESSING; DRESSING, WOUND, DRUG

Model Number 413569

Device Problem Failure To Adhere Or Bond (1031)

Patient Problems Burn(s) (1757); Discharge (2225)

Event Date 09/30/2014

Event Type  Injury  

Event Description

It was reported the end user was readmitted to the hosp due to a suspected wound infection from facial burn.The dressing was initially applied to the pt's face on (b)(6) 2014.After five days, the pt's face was still very wet over his forehead and all the dressing was loose.Once the dressing was removed, a thick layer of slough was visible.Upon admittance to the hosp, soaks and facial toilet was performed, as well as taking a wound swab to rule out infection.The wound swab revealed growth of enterobacter cloacae which was not clinically significant.The wound was then treated with aggressive non-surgical debridement to remove the thick layer of slough.The end user was reviewed on (b)(6) 2014 and the wound appeared to have improved much further than expected so the subject was discharged home.A further review on (b)(6) 2014 revealed the wound has improved to 90% closure.

Manufacturer Narrative

Based on the available info, this event is deemed to be a serious injury.It was further reported that the end user did not receive any antibiotics and was managed with standard care.Per the info provided, the end user was part of a clinical trial study to assess the safety and performance of the aquacel ag+ extra in partial thickness burns (protocol number (b)(4), protocol name, "(b)(4) study to assess the safety and performance of aquacel ag+ extra in partial thickness burns," (b)(4)).It was reported the pt was discontinued from the clinical trial study.A return sample for eval is not expected.Should add'l info become available, a f/u report will be submitted.

• Brand Name: AQUACEL AG EXTRA DRESSING
• Type of Device: DRESSING, WOUND, DRUG
• Manufacturer (Section D): CONVATEC LIMITED; first avenue; deeside industrial park; deeside, flintshire CH5 2 NU; UK CH5 2NU
• Manufacturer Contact: matthew walenciak, assoc. dir. ; 211 american ave; greensboro, NC 27409 ; 9083779293
• MDR Report Key: 4189052
• MDR Text Key: 15996661
• Report Number: 1000317571-2014-00094
• Device Sequence Number: 1
• Product Code: FRO
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K121275
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/30/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/01/2015
• Device Model Number: 413569
• Device Catalogue Number: 413569
• Device Lot Number: 3L00194
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/30/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2013
• 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
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 40 YR