Model Number 31626 |
Device Problem
Insufficient Information (3190)
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Patient Problems
Adhesion(s) (1695); Hernia (2240); Obstruction/Occlusion (2422); No Known Impact Or Consequence To Patient (2692)
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Event Date 03/13/2015 |
Event Type
Injury
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Manufacturer Narrative
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A follow up report will be submitted upon the completion of the investigation into this event.This report is based upon allegations made in a potential lawsuit in which atrium medical would be named as a defendant.This report shall not be considered as an admission by atrium medical that the product described in the pre-suit claim and described herein are or were defective, or that it had any causal relationship to any injuries allegedly suffered by the claimant.
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Event Description
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This event is deemed reportable based on the allegations in a pre-suit claim which, while unsubstantiated, suggest that a reportable event may have occurred during use of atrium medicals mesh product.Claimant attributes unspecified complications to the mesh.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 review of all manufacturing lot history and sterilization records was conducted.All in-process specifications and release criteria were met, including seal strength testing on both the pre-and-post-sterile packaging.Ball burst and suture retention testing was also conducted on the mesh at incoming and fourier transform infrared spectroscopy was performed on the cured coated mesh panels.
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Event Description
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Allegedly, the patient continued to develop new areas of herniation and failed repairs due to muscle wall weakness.
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Event Description
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Allegedly, plaintiff also experienced abdominal pain, adhesions, umbilical recurrent hernia, fat necrosis and small bowel obstruction.
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Search Alerts/Recalls
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