MAUDE Adverse Event Report: CONVATEC INC AQUACEL AG - SURGICAL COVER DRESSINGS; DRESSING, WOUND, DRUG 79 FRO

Model Number 412012

Device Problem Increased Sensitivity (2535)

Patient Problems Rash (2033); Increased Sensitivity (2065); Skin Irritation (2076)

Event Date 05/22/2014

Event Type  Injury  

Event Description

It is reported that the pt developed a red, bumpy rash as a result of a difficult removal of the aquacel surgical dressing which was applied in the operating room related to total knee replacement surgery, and remained in place for seven (7) days post operative.It is reported that upon removal of the dressing on (b)(6) 2014 the nurse found the dressing difficult to remove, and stated that there was a lot of adhesive left behind on the pt's skin resulting in a red bumpy rash with intact skin.They have called the surgery and are awaiting approval from surgeon for cortisone cream to be applied to the area.Please note: this report represents pt # of 2 and is related to the following pt identifier#: (b)(6) and reporting under mfr.Report #: 1049092-2014-00225.

Manufacturer Narrative

Based on the available information, this event is deemed to be a serious injury.Complainant was provided instructions to use a no sting adhesive remover on the residue, and to notify convatec with any questions or concerns.It is reported that the lot number was not available for this product.No additional pt/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.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 79 FRO
• Manufacturer (Section D): CONVATEC INC; 211 american ave.; greensboro NC 27409
• Manufacturer Contact: matthew walenciak, int assc dir ; 211 american ave.; greensboro, NC 27409 ; 9083779293
• MDR Report Key: 3940288
• MDR Text Key: 4571998
• Report Number: 1049092-2014-00224
• 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: 05/23/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/19/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 412012
• Device Catalogue Number: 412012
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/23/2014
• 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