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

Model Number 420670

Device Problem Increased Sensitivity (2535)

Patient Problems Skin Irritation (2076); Skin Inflammation (2443)

Event Date 06/13/2014

Event Type  Injury  

Event Description

It is reported that an aquacel ag surgical cover dressing applied by the orthopedic surgeon to post knee replacement incision in or; removed after seven days and then applied another ag surgical cover dressing.The second ag surgical cover dressing was removed and a smith and nephew releaser product was used related to edematous lower extremity of the patient.Blistering was noted outside of the dressing edges resulting in the dressing being removed without difficulty, with no evidence of redness or blistering to underneath the border or the aquacel ag area of dressing.It is further reported that the only blistering or slight redness noted on the patient, was intact blistering to the skin beyond where the dressing was in contact with the skin outside of the dressing border.Lastly, a xeroform dressing was placed to the blistered area as treatment.

Manufacturer Narrative

Based on the available information, this event is deemed to be a serious injury.Additional information received via email dated (b)(4) 2014 states that it is "unknown whether the patient had a history of venous insufficiency, etc.That may have contributed." in addition, "this facility is well educated on placing the dressing onto the knee at 30 degree angle." 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.Reported to the fda on (b)(4) 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, assoc dir ; 211 american ave.; greensboro, NC 27409 ; 9083779293
• MDR Report Key: 3971249
• MDR Text Key: 4632352
• Report Number: 1049092-2014-00280
• 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: Nurse
• Type of Report: Initial
• Report Date: 06/13/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/09/2014
• 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: 06/13/2014
• 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