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Model Number 31201 |
Device Problem
Material Fragmentation (1261)
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Patient Problems
Pain (1994); Seroma (2069); Hernia (2240)
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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 multiple additional surgeries, mesh debris left powdery gold appearance, drainage, seroma, adhesions, chronic pain multiple strangulated recurrent hernias.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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Additional information section: a2, b7, d4, h4, h6.Based on the review of the device history 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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N/a.
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Search Alerts/Recalls
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