Model Number 31528 |
Device Problem
Insufficient Information (3190)
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Patient Problems
Adhesion(s) (1695); Strangulation (2084)
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Event Date 10/27/2016 |
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.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.
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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 experienced adhesions more than two years after mesh was implanted.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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A thorough review of the device history records indicates that this lot of hernia mesh passed all quality inspections and performance inspections.Based on the details of the complaint and acceptable lot qualification results atrium medical can find no fault with the product in question.
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Event Description
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Allegedly, patient also experienced bowel resection and incarcerated ventral hernia.
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Search Alerts/Recalls
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