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Model Number 31612 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Abscess (1690); Adhesion(s) (1695); Purulent Discharge (1812); Unspecified Infection (1930); Scar Tissue (2060)
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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.Not returned.
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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 plaintiff allegedly experienced infection, adhesions, abscess, seroma and additional 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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Based on the review of the device history and sterilization records and product complaint details atrium can find no fault with the product.This lot of mesh passed all quality and performance requirements.
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Event Description
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Plaintiff also allegedly experienced pain, enlarged mesenteric lymph node, rolled up mesh, scar tissue, drainage, serous fluid, wound packing, debridement, mrsa, purulent fluid, sinus tract and wound vac placement.
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Manufacturer Narrative
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Correction: date received by mfg (section g.3) was incorrectly reported as 02/21/2022 and the date should have been 01/21/2022.
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Event Description
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N/a.
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Search Alerts/Recalls
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