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Model Number 31628 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Abscess (1690); Adhesion(s) (1695); Unspecified Infection (1930); Hernia (2240); Skin Inflammation/ Irritation (4545)
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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.This report is based upon allegations made in a lawsuit in which atrium medical is 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 lawsuit which, while unsubstantiated, suggest that a reportable event may have occurred during use of atrium medical¿s mesh product.Plaintiff allegedly experienced additional surgery, infected and wadded up mesh, incision and drainage of infected abdominal wall abscess with subfascial extension, draining sinus, recurrent incisional hernia, repaired with placement of new mesh, adhesions, and pain.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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Event Description
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Plaintiff also allegedly experienced staph aureus, suture granuloma, inflammation, granulation tissue, debridement and sinus tract.
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Manufacturer Narrative
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Correction section: d6 & b7 - a tacshield mesh was implanted simultaneously not subsequently.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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