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Model Number 31107 |
Device Problem
Output Problem (3005)
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Patient Problems
Adhesion(s) (1695); Unspecified Infection (1930); Pain (1994)
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Event Type
Injury
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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, digestive problems, scar tissue, infection, mesh removal, wound vac treatment, adhesions, debridement of the skin and additional surgeries.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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We are unable to fully investigate this event as no product code, lot number, or sample was provided.This report is based upon allegations made in a lawsuit in which atrium medical is named as a defendant.This report shall not be considered as an admission by atrium medical that the product described in the lawsuit claim and described herein is or was defective, or that it had any causal relationship to any injuries allegedly suffered by the plaintiff.Not returned.
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Event Description
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Plaintiff also allegedly experienced recurrence, granular tissue, purulence, sinus tract, wadded up mesh, inflammation, lack of incorporation, wound vac and myocutaneous advancement flaps created.
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Manufacturer Narrative
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Additional information section: a2, b5, b7, d4, h4, h6.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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Search Alerts/Recalls
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