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

Model Number 412011

Device Problem Increased Sensitivity (2535)

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

Event Date 06/19/2014

Event Type  Injury  

Event Description

It is reported that the patient developed what the physician believes was an allergic reaction with signs of redness described as an "eczema" under the hydrocolloid border and along edges of the aquacel ag surgical cover dressing, which was placed immediately after patient's left knee surgery, and removed and discontinued seven (7) days after application replaced by dry gauze to the knee surgical site incision resulting in no untoward affect or infection to patient.It is further reported that the patient was treated with prophylactic antibiotic keflex during the post-operative visit related to the knee surgery, and there were no protectant wipes or adhesives like "mastisol" used under dressing, and no corticosteroids or creams applied or prescribed.

Manufacturer Narrative

Based on the available information, this event is deemed to be a serious injury.No further details provided.No size of dressing is known at this time and unable to provide ref number.First attempt to contact; voicemail left.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.Note: the actual date of event is unk, 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, interim assoc ; 211 american ave.; greensboro, NC 27409 ; 9083779293
• MDR Report Key: 3950989
• MDR Text Key: 4606718
• Report Number: 1049092-2014-00298
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/19/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 412011
• Device Catalogue Number: 412011
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/19/2014
• 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
• Patient Weight: 71