MAUDE Adverse Event Report: CONVATEC INC. AQUACEL AG - SURGICAL COVER DRESSINGS; DRESSING, WOUND, DRUG

Model Number 420670

Device Problems Increased Sensitivity (2535); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Local Reaction (2035); Increased Sensitivity (2065); Skin Inflammation (2443)

Event Date 07/02/2014

Event Type  Injury  

Event Description

It is reported that the patient, who had knee replacement surgery two (2) weeks ago, developed a skin reaction presented as redness and blisters resulting from contact with the adhesive of the hydrocolloid portion of the dressing after seven (7) days weartime.It is further reported that incision site was closed with suture; sterile strips and the application of aquacel ag surgical cover dressings without skin prep.Lastly, reports states the patient went to rehabilitation without incident, and signs of symptoms of he skin reaction became evident requiring treatment with hydrocortisone cream per physicians orders.

Manufacturer Narrative

Based on the available information, this event is deemed to be a serious injury.No additional patient/event details have ben provided to date.A return sample for evaluation is not expected.Should additional information become available, a follow-up report will be submitted.Reported to the fda on july 23, 2014.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 AG - SURGICAL COVER DRESSINGS
• Type of Device: DRESSING, WOUND, DRUG
• Manufacturer (Section D): CONVATEC INC.; 211 american ave.; greensboro NC 27409
• Manufacturer Contact: matthew walenciak, int.assoc.dir. ; 211 american ave.; greensboro, NC 27409 ; 9083779293
• MDR Report Key: 3987317
• MDR Text Key: 4636421
• Report Number: 1049092-2014-00336
• 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,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/02/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/24/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 420670
• Device Catalogue Number: 420670
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/02/2014
• 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