AVANOS MEDICAL INC. MIC-KEY LOW-PROFILE GASTROSTOMY FEEDING TUBE - 12 FR, 0.8 CM; DH EF BALLOON TUBES PRODUCTS
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Model Number 0120-12-0.8 |
Device Problem
Pressure Problem (3012)
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Patient Problem
Tissue Breakdown (2681)
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Event Date 12/04/2019 |
Event Type
Injury
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Manufacturer Narrative
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The actual complaint product was not returned for evaluation.A review of the device history record is not possible as no lot number was provided.Root cause could not be determined.All information reasonably known as of 27-dec-2019 has been included in this health authority report.Should additional information be obtained, a follow-up health authority report will be provided.The information provided by avanos medical, inc.Represents all of the known information at this time.Avanos medical, inc.Has no independent knowledge of the event reported but is relaying the information that was provided by the user facility where the incident occurred.This product incident is documented in the avanos medical, inc.Complaint database and identified as complaint (b)(4).
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Event Description
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Avanos medical, inc.Received a single report that referenced five different incidences, which were associated with separate units, involving five different events.This is the third of five reports.Refer to 9611594-2019-00259 for the first event.Refer to 9611594-2019-00260 for the second event.Refer to 9611594-2019-00262 for the fourth event.Refer to 9611594-2019-00263 for the fifth event.It was reported the patient experienced skin breakdown and pressure under the newly placed mic-key gastrostomy tube.The surgeons placing the device are disagreeing with the wound ostomy team that these are pressure related injuries.However, the wound ostomy care nurse (wocn) team is staging it as a pressure injury.
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