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Model Number 31536 |
Device Problem
Insufficient Information (3190)
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Patient Problems
Adhesion(s) (1695); Emotional Changes (1831); Unspecified Infection (1930); Pain (1994); Swelling (2091); 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.
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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, fluid collection, adhesions, infection, hernia recurrence, and mesh removal.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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Investigation: 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 allegedly also experienced unincorporated mesh, hemorrhage, foreign body giant cell reaction, scar removal, fibrosis, immunocompromised, ascites and abdomen reconstruction.
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Search Alerts/Recalls
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