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Model Number 31202 |
Device Problem
Insufficient Information (3190)
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Patient Problems
Adhesion(s) (1695); Pain (1994); Scar Tissue (2060); Hernia (2240)
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Event Date 05/15/2013 |
Event Type
Injury
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Manufacturer Narrative
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A thorough investigation was not able to be performed as no product code, lot number, or sample was provided.
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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 medicals mesh product.Allegedly, after the mesh was implanted for incarcerated umbilical hernia repair, plaintiff developed pain.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 and sterilization records indicates that this lot of hernia mesh passed all quality inspections and performance inspections.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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Plaintiff also allegedly experienced recurrent umbilical hernia, scar tissue, and adhesions.
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Search Alerts/Recalls
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