Model Number 31544 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Purulent Discharge (1812); Unspecified Infection (1930); Strangulation (2084)
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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.
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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 was implanted with c-qur mesh.Plaintiff allegedly experienced infection and had to have revision surgery.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.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, plaintiff also experienced incarcerated hernia, incisional hernia and purulent drainage.
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Search Alerts/Recalls
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