Catalog Number DSD5005 |
Device Problem
Chemical Problem (2893)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 01/17/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Attempts are being made to obtain additional information.Upon completion of the investigation, a follow-up report will be submitted.
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Event Description
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This is 2 of 3 reports linked to mfg report numbers: 3003418325-2021-00001, 3003418325-2021-00003.A facility reported that duraseal (dsd5005) was thinner than normal.The patient was prepped for surgery and the product was in contact with the patient.There was no delay in surgery, and the case continued as planned using the thinner duraseal and no adverse impact to patient was reported.Additional information has been requested.
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Manufacturer Narrative
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Duraseal (dsd5005) was returned for evaluation.The root cause is undetermined and was unable to be confirmed in the samples and complaint evaluation.A dhr review and trending were performed as part of the evaluation.Proper finished good testing was performed prior to release as indicated in the device history record.Product was received for analysis and the investigation could not confirm the complaint reported condition.Per the fmea, potential causes of failure include: performance, adhesion barrier.The risk remains acceptable per the risk analysis.The reported condition was not confirmed.
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Search Alerts/Recalls
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