Model Number 420823 |
Device Problems
Delivered as Unsterile Product (1421); Contamination /Decontamination Problem (2895)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/18/2021 |
Event Type
malfunction
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Event Description
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It was reported that on (b)(6) 2021, there was foreign matter (hair) in the dressing and the product was not used by the patient.Photographs depicting the issue were received from the complainant.
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Manufacturer Narrative
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Common device name : dressing,wound, hydrophilic.(b)(6).(b)(4).Based on the available information, this event is deemed to be a reportable malfunction.To date no additional information has been received.Should additional information become available, a follow-up report will be submitted.(b)(4).
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Event Description
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To date no additional patient or event details have been received.
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Manufacturer Narrative
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This emdr is being submitted to correct manufacturing site.
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Event Description
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To date no additional patient or event details have been received.
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Search Alerts/Recalls
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