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Model Number 31628 |
Device Problem
Insufficient Information (3190)
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Patient Problems
Abdominal Pain (1685); Adhesion(s) (1695); Autoimmune Reaction (1733); Fistula (1862); Inflammation (1932); Scar Tissue (2060); Seroma (2069); Hernia (2240)
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Event Date 12/09/2013 |
Event Type
Injury
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Manufacturer Narrative
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We are unable to fully investigate this event as no product code, lot number, or sample was provided.This report is based upon allegations made in a lawsuit in which atrium medical is named as a defendant.
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Event Description
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This event is deemed reportable based on the allegations in a lawsuit which, while unsubstantiated, suggest that a reportable event may have occurred during use of atrium medical's mesh product.Allegedly, plaintiff went to hospital for abdominal pain she was having.Since this is a legal matter, the case has been turned over to legal counsel and further information obtained through investigation or discovery may fall under the attorney/client and/or work product privilege.However, atrium will supplement this report as appropriate if additional information comes to its attention.
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Manufacturer Narrative
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A thorough review of the device history records indicates that this lot of hernia mesh passed all quality inspections and performance inspections.A review of the sterility records also indicates that the product was properly sterilized with no eto cycle deviations.Based on the details of the complaint and acceptable lot qualification results atrium medical can find no fault with the product in question.
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Event Description
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Allegedly, patient also experienced adhesions, seroma, inflammation, fistula, multiple hernias, autoimmune rejection, scar tissue and foreign body rejection.
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Search Alerts/Recalls
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