Catalog Number UNK STRATTICE |
Device Problems
Patient-Device Incompatibility (2682); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Hernia (2240); Insufficient Information (4580)
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Event Date 01/07/2019 |
Event Type
Injury
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Manufacturer Narrative
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No lot information provided.If additional information is received a follow up will be submitted.
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Event Description
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Patient representative reported (b)(6) male patient had a hernia repair on (b)(6) 2017 with strattice.On (b)(6) 2019, he was diagnosed with an infected mesh and required explant two years post operation.
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Event Description
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This is follow up #1 to report that additional information was received from legal on june 7, 2022 that the valid lot number associated with this event is sp100559.As reported in the initial: patient representative reported 50yo male patient had a hernia repair on (b)(7) 2017 with strattice.On (b)(6) 2019, he was diagnosed with an infected mesh and required explant two years post op.
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Manufacturer Narrative
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Internal investigation into strattice lot sp100559 included a review of the reported information, review of the device history records, and a review of the complaint history records.The investigation resulted in no remarkable findings, including no other complaints reported against the lot and no deviations or related non-conformances revealed during processing.The lot was terminally sterilized within the process parameters and met all qc release criteria.As of 06/21/2022, of the (b)(4) devices released to finished goods for lot sp100559, 189 have been distributed with 96 reported as implanted.Based on our internal review with no remarkable findings, a relationship between the strattice and this event could not be determined.No further actions are required as a nonconformance could not be confirmed.
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Search Alerts/Recalls
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