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Catalog Number 2025002 |
Device Problem
Patient-Device Incompatibility (2682)
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Patient Problem
Hernia (2240)
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Event Date 09/13/2019 |
Event Type
Injury
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Manufacturer Narrative
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A investigation into lot s11050 resulted in no remarkable findings and one unrelated processing deviations and one unrelated nonconformance revealed.(b)(4) devices released to finished goods for lot s11050, (b)(4) have been distributed.Of the (b)(4) distributed, (b)(4) have been reported as implanted.One other unrelated complaints against lot s11050 were revealed.Lot s11050 was aseptically processed, terminally sterilized and met all qc release criteria.
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Event Description
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Patient representative reported a (b)(6) yo male patient had strattice, 2025002 and 1010002, implanted on (b)(6) 2012 for a hernia repair.Patient had a surgery on (b)(6) 2019 for a bulging re-occurrent hernia and mesh was explanted.Lot number s11050-239 and s11075-053.This mdr for s11050.
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Search Alerts/Recalls
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