Model Number 98701 |
Device Problem
Migration (4003)
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Patient Problem
Foreign Body In Patient (2687)
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Event Date 02/10/2022 |
Event Type
malfunction
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Event Description
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Fda medwatch / fda user facility report (b)(4) reported that the foreign body was removed from the patient¿s abdominal wound during the wound clinic visit.There was no reported injury.Additional information received 03may2022 reported that as of 17feb2022, the site was overall healed with no residual pain.
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Manufacturer Narrative
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The actual complaint product was not returned for evaluation.Root cause could not be determined.A review of the device history record is not possible as no lot number was provided.All information reasonably known as of 07 may 2022 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 complaint database and identified as complaint (b)(4).
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Event Description
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Additional information received 19sep2022 reported, the original procedure date was july 2021.Fda medwatch / fda user facility report #(b)(4) reported, the t-fastener migrated through the stomach and into the skin where it caused an irritation.
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Manufacturer Narrative
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All information reasonably known as of 30 sep 2022 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 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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Event Description
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Additional information received 19sep2022 reported, the original procedure date was in july 2021.It was reported, the t-fastener migrated through the stomach and into the skin where it caused an irritation.
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Manufacturer Narrative
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Additional information: b5.Correction: a2; b5.All information reasonably known as of 13 oct 2022 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 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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