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Device Problem
Device Dislodged or Dislocated (2923)
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Patient Problems
Pain (1994); Skin Inflammation/ Irritation (4545)
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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.Plaintiff allegedly experienced pain and suffering, hernia repair, displaced mesh and inflammation.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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Event Description
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Plaintiff also allegedly experienced incarceration.
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Manufacturer Narrative
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Additional information section: a2, b5, b7, h6.
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Search Alerts/Recalls
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