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Model Number 31528 |
Device Problem
Device Operates Differently Than Expected (2913)
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Patient Problems
Unspecified Infection (1930); Necrosis (1971); Pain (1994); Seroma (2069); Hernia (2240); Anxiety (2328)
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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.Related files: 3011175548-2017-00215 and 3011175548-2017-00216.
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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.Allegedly, plaintiff was implanted with c-qur mesh.Plaintiff allegedly experienced mesh failure, seroma, infection, need for further surgery, pain and suffering, mental anguish and continuing disability.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 requirement.
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Event Description
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Allegedly plaintiff also experienced recurrence, non-healing wound, debridement, necrosis, serous fluid, fibrinous tissue, serosanguinous, and incision and drainage.
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Search Alerts/Recalls
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