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Model Number 31533 |
Device Problems
Material Twisted/Bent (2981); Appropriate Term/Code Not Available (3191)
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Patient Problems
Adhesion(s) (1695); Unspecified Infection (1930); Pain (1994); 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.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 hernia recurrence, folded mesh, dense adhesions, bowel obstruction, multiple revision surgeries, infection, pain and suffering.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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N/a.
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Manufacturer Narrative
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Corrected section: d1, g5.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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Search Alerts/Recalls
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