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Model Number UNKNOWN |
Device Problem
Break (1069)
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Patient Problem
No Code Available (3191)
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Event Date 04/30/2018 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).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 26 jul 2018 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 (b)(4).Device not reutrned.
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Event Description
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It was reported that two of the staples failed the day after placement.The gastric button was lost, and a new procedure was required for the patient.No further information provided.
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Manufacturer Narrative
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All information reasonably known as of 02 oct 2018 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 halyard health complaint database and identified as complaint (b)(4).
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Event Description
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Per additional information received 24 sep 2018, the customer has stated that they cannot confirm if a avanos placement kit was used in the procedure.No further information is available.
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Search Alerts/Recalls
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