MAUDE Adverse Event Report: CONVATEC LIMITED AQUACEL EXTRA; HYDROPHILIC WOUND DRESSING, 79 NAC

Model Number 420672

Device Problem Sticking (1597)

Patient Problem Pain (1994)

Event Date 02/27/2014

Event Type  Injury  

Event Description

It is reported that samples of aquacel extra, aquacel heel foam and no adhesive aquacel foam was provided to the nursing home to use on pts' leg ulcers.Feedback provided from complainant indicated that they had stopped using the dressings because they had found them to stick to the leg ulcer wounds of 2 different pts.They had used the aquacel extra and aquacel foam together (no other foam was used) and bandaging to hold the dressings in place and the ulcers were moderately exudating.The nurse only tried the dressings once and then discontinued use of aquacel extra, going back to using inadine with biatain, for the gel that had formed with exudates from the wounds had dried and hardened which was very difficult to remove resulting in extreme pain to pt.Lastly, the pt was provided treatment to leg ulcers on three (3) separate areas on left leg, moderately exudating - each covered by 10x10 aquacel extra dressing with a 15x20 non-adhesive secondary dressing.Note: this report represents pt #1 and is related to pt identifier #: (b)(6) reported under manufacturer's report#: 1049092-2014-00171.

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 is stated as follows: "finally i have the info from (b)(6) regarding the pts on whom the aquacel stuck.There are some details she either couldn't or wouldn't give to me, and one of the pts died of an unrelated issue some time ago, and their file has been closed and 'sent off' so she no longer has access to the information.The incidents apparently happened at the beginning of (b)(6), but i didn't find out about them until my last visit on the (b)(6).The nurse could only talk to me for 10 mins as she was still very busy.The nurse was not absolutely sure, but said the dressings were applied in the week following my visit on the (b)(6), which would mean the dressings were applied in the week beginning (b)(6)." 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 EXTRA
• Type of Device: HYDROPHILIC WOUND DRESSING, 79 NAC
• Manufacturer (Section D): CONVATEC LIMITED; first ave; deeside industrial park; deeside CH5 2NU; UK CH5 2NU
• Manufacturer Contact: matthew walenciak, int assoc dir ; 211 american ave; greensboro, NC 27409 ; 9083779293
• MDR Report Key: 3883651
• MDR Text Key: 4596670
• Report Number: 1000317571-2014-00033
• Device Sequence Number: 1
• Product Code: NAC
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: EXEMPT
• 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: 05/09/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 420672
• Device Catalogue Number: 420672
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/09/2014
• 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 Age: 77 YR
• Patient Weight: 92