Model Number 31200 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Type
Injury
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Manufacturer Narrative
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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 requirement.This report is based upon allegations made in a potential lawsuit in which atrium medical would be named as a defendant.
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Event Description
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This event is deemed reportable based on the allegations in a potential lawsuit which, while unsubstantiated, suggest that a reportable event may have occurred during use of atrium medical¿s mesh product.Plaintiff allegedly experienced unspecified injuries.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 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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Plaintiff allegedly also experienced chronic pain, inflammation, mesh infection, and was required to endure subsequent invasive surgery to repair recurrent hernia.
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Search Alerts/Recalls
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