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Catalog Number 2025002 |
Device Problem
Patient-Device Incompatibility (2682)
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Patient Problems
Hernia (2240); Obstruction/Occlusion (2422)
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Event Date 06/28/2018 |
Event Type
Injury
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Manufacturer Narrative
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Qa investigation into lot sp100477 resulted in no remarkable findings and no deviations and no nonconformance revealed.210 devices were released to finished goods and 139 have been distributed.Of the 139 distributed, 79 have been reported as implanted no other complaints against the lot sp100477 were revealed.Lot sp100477 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 male patient had strattice, 2025002, implanted on (b)(6) 2017 for a ventral hernia repair.Patient was hospitalized on (b)(6) 2018 and a revision surgery took place for a bowel obstruction and hernia revision on b)(6) 2018.Lot number sp100477-004.
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Search Alerts/Recalls
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