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Model Number 420672 |
Device Problem
Sticking (1597)
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Patient Problem
Pain (1994)
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Event Date 03/03/2014 |
Event Type
Injury
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Event Description
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It is reported that samples of aquacel extra, aquacel heel foam and non adhesive aquacel foam was provided to the nursing home to use on pt's 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 a 10x10 aquacel extra dressing with a 15x20 non-adhesive secondary dressing.Note: this report is related pt identifier(s); (b)(6) reported under mfr's reports: 1000317571-2014-00033, 1049092-2014-00171, 00209 respectively.
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Manufacturer Narrative
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Based on the available info, this event is deemed to be a serious injury.Add'l info received via email dated (b)(6) 2014 is stated as follows: "finally i have the info from (b)(6) nursing home 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 info.The incidents apparently happened at the beginning of march, 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 could mean the dressings were applied in the week beginning (b)(6)".No add'l pt/event details have been provided to date.A return sample for eval is not expected.Should add'l info become available, a f/u report will be submitted.Reported to fda on june 09, 2014.Convatec will continue to track and monitor such complaints according to convatec inc's.Complaint handling and capa procedures.
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Search Alerts/Recalls
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