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

Model Number 420804

Device Problem Increased Sensitivity (2535)

Patient Problems Local Reaction (2035); Skin Irritation (2076)

Event Date 05/29/2014

Event Type  Injury  

Event Description

It is reported that the patient experienced an issue with a skin reaction around the adhesive border of the aquacel foam adhesive dressing.

Manufacturer Narrative

Based on the available information, this event is deemed to be a serious injury.No additional patient/event details have been provided to date.A return sample for evaluation is not expected.Should additional information become available, a follow-up report will be submitted.Third party manufacturer: (b)(4).Note: the actual date of event is unknown, so the date used was the date convatec became aware.Convatec will continue to track and monitor such complaints according to convatec inc's.Complaint handling and capa procedures.

• Brand Name: AQUACEL FOAM
• Type of Device: DRESSING, WOUND, DRUG
• Manufacturer (Section D): CONVATEC, INC.; 211 american ave.; greensboro NC 27409
• Manufacturer Contact: matthew walenciak, interim assoc ; 211 american ave.; greensboro, NC 27409 ; 9083779293
• MDR Report Key: 3937305
• MDR Text Key: 4573972
• Report Number: 1049092-2014-00235
• Device Sequence Number: 1
• Product Code: FRO
• Combination Product (y/n): N
• PMA/PMN Number: K123481
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 05/29/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/25/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 420804
• Device Catalogue Number: 420804
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/29/2014
• 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