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Model Number 1000306-00 |
Device Problem
Patient-Device Incompatibility (2682)
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Patient Problems
Adhesion(s) (1695); Hernia (2240); Skin Inflammation/ Irritation (4545)
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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 requirements.This report is based upon allegations made in a potential lawsuit in which atrium medical would be named as a defendant.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 recurrence, adhesions, painful, additional surgery incarceration and inflammation.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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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.This report is based upon allegations made in a potential lawsuit in which atrium medical would be named as a defendant.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 recurrence, adhesions, painful, additional surgery incarceration and inflammation.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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Search Alerts/Recalls
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