MAUDE Adverse Event Report: WEBTEC CONVERTING, LLC AQUACEL FOAM N/ADH 15X15CM (1X5PK); DRESSING,WOUND,HYDROPHILIC

Model Number 420635

Device Problems Leak/Splash (1354); Device Operates Differently Than Expected (2913)

Patient Problem Complaint, Ill-Defined (2331)

Event Type  Injury  

Manufacturer Narrative

Convatec is submitting this report as a result of activities related to convatec remediation protocol (b)(4) and protocol (b)(4).Convatec is submitting this report pursuant to the provisions of 21cfr part 803.Blank fields on this form indicate the information is unknown, unavailable or unchanged.Any additional information received regarding this event after filing this report will be filed on a supplemental report (medwatch 3500a).

Event Description

Healthcare professional reports that they discontinued use of two layers of aquacel extra and aquacel foam non adhesive as the "wet legs" had begun to macerate which they attributed to the dressing.It is also reported that the patient has begun acticoat prophylactically as they felt unwell, but no other clinical signs of infection.They are also using two super absorbant dressings.

• Brand Name: AQUACEL FOAM N/ADH 15X15CM (1X5PK)
• Type of Device: DRESSING,WOUND,HYDROPHILIC
• 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: 5124856
• MDR Text Key: 27443172
• Report Number: 2320643-2015-30209
• Device Sequence Number: 1
• Product Code: NAC
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Nurse
• Report Date: 02/27/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/02/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Nurse
• Device Model Number: 420635
• 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: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention