Model Number 50-6016E1 |
Device Problem
Migration (4003)
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Patient Problem
Peritonitis (2252)
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Event Type
Injury
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Manufacturer Narrative
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A review of the device history record is not possible as no lot number was provided.The actual complaint product was not returned for evaluation.Root cause could not be determined.All information reasonably known as of 08 jun 2021 has been included in this health authority report.Should additional information be obtained, a follow-up health authority report will be provided.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 two different incidences, which were associated with separate units, involving two different patients.This is the second of two reports.Refer to 3006646024-2021-00007 for the first report.It was reported that the device displaced soon after placement, resulting in peritonitis.According to the customer, the device was not pulled and was identified in the stomach at procedure.
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Event Description
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Additional information received 10-jun-2021 indicated the patient developed peritonitis within one week of the peg placement.The device was placed by an experienced user.Additional information received 18-jun-2021 indicated the device was placed on (b)(6) 2021.An oesophagogastroduodenoscopy (ogd) revealed an oesophageal tumor at 30cm.The patient's current condition was "ok, eating and drinking now.Peg remains insitu (not used) as high risk to remove due to patient co morbidities and ga risk).".
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Manufacturer Narrative
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All information reasonably known as of 30 jun 2021 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.Despite good faith efforts to obtain additional information, the complainant/reporter was unable or unwilling to provide any further patient, product, or procedural details to avanos medical inc.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).This information is submitted pursuant to 21cfr803, in compliance with the medical device reporting requirement and should not be considered to be an admission that an avanos medical inc.Product is defective or caused serious injury.
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Search Alerts/Recalls
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