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Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Abdominal Pain (1685); Adhesion(s) (1695); Unspecified Infection (1930); Burning Sensation (2146); Hernia (2240); Fibrosis (3167)
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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.Device evaluated by manufacturer? 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 severe abdominal pain and burning, tender recurrent incarcerated ventral hernia protruding above mesh, abdominal pain, unable to continue daily routines and/or any physical activity due to 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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Event Description
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Plaintiff allegedly also experienced adhesions, fibrous tissue, unincorporated mesh, purulent drainage and infection.
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Search Alerts/Recalls
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