MAUDE Adverse Event Report: CONVATEC LIMITED AQUACEL AG + EXTRA; DRESSING, WOUND, DRUG, 78 FRO

Model Number 413567

Device Problem Device Emits Odor (1425)

Patient Problem Fluid Discharge (2686)

Event Date 06/02/2014

Event Type  Injury  

Event Description

It was reported complainant stated "when switching therapy of an leg ulcer from usage of an calcium alginate to aquacel ag + extra the exsudate in the turned green and developed order.".

Manufacturer Narrative

Based on the available info, this event is deemed a serious injury.It was further reported the product was used on the shank for two days before the event occurred.Also, the usage of aquacel ag + extra wasn't stopped because the process of wound healing was very positive.Additional info was received on (b)(4) 2014 via email informing it is unk if patient was on antibiotics and the wound was not cultured.No additional patient/event details have been provided to date.Should additional info become available a follow-up report will be submitted.Reported to the fda on 07/02/2014.Note: the actual date of event is unk, so the date used was the date convatec became aware.

• Brand Name: AQUACEL AG + EXTRA
• Type of Device: DRESSING, WOUND, DRUG, 78 FRO
• Manufacturer (Section D): CONVATEC LIMITED; first avenue; deeside industrial park; deeside, flintshire CH5 2 NU; UK CH5 2NU
• Manufacturer Contact: matthew walenciak ; 211 american avenue; interim associate director; greensboro, NC 27409 ; 8083779293
• MDR Report Key: 4009783
• MDR Text Key: 16993852
• Report Number: 1000317571-2014-00042
• Device Sequence Number: 1
• Product Code: FRO
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K121275
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative,Distributor
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 06/02/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/03/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 413567
• Device Catalogue Number: 413567
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/02/2014
• 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
• Patient Outcome(s): Required Intervention