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Catalog Number 1020002 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Hernia (2240)
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Event Date 09/05/2012 |
Event Type
Injury
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Manufacturer Narrative
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Internal investigation into strattice lot s10969 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 related deviations or non-conformances revealed during manufacturing.The lot was terminally sterilized within the process parameters and met all qc release criteria.As of 1/24/22, all 167 devices released to finished goods have been distributed with 120 devices reported as implanted.
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Event Description
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It was reported through legal that a (b)(6) male patient underwent hernia repair surgery on or about (b)(6) 2012 at deaconess health system in (b)(6).The patient was implanted with lot s10969-105.After surgery, the patient returned to the hospital on or about (b)(6) 2012 and was diagnosed with a recurrent parastomal hernia.On or about (b)(6)
, the patient underwent a parastomal herniorrhaphy with mesh at deaconess health system and was implanted with strattice lot s11047-107.The patient was (b)(6) at that time.The patient returned to the hospital on or about (b)(6) 2013 and was diagnosed with chronic abdominal pain with parastomal hernia.The patient had a repair of the parastomal hernia on or about (b)(6) 2013 at barnes-jewish hospital.This record is associated with device lot s10969-105.
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Search Alerts/Recalls
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