Model Number 31633 |
Device Problem
Patient-Device Incompatibility (2682)
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Patient Problem
Foreign Body Reaction (1868)
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Event Type
Injury
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Event Description
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This event is deemed reportable based on the allegations in a lawsuit, while unsubstantiated, suggest that a reportable event may have occurred during use of atrium medicals mesh product.Plaintiff was allegedly implanted with a mesh and suffered an adverse reaction (foreign body).Allegedly an abdominal mass was removed which was noted to be contracted mesh and cultures taken at time of removal indicated no infection.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 investigation was not able to be performed as no product code, lot number, or sample was provided.A review of complaints was performed and there have not been any similar reports related to a device malfunction.This report shall not be considered as an admission by atrium medical that the product described in the lawsuit and described herein are or were defective, or that it had any casual relationship to any injuries allegedly sustained by the plaintiff.
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Manufacturer Narrative
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A follow up report will be submitted upon completion of the investigation into this event.
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Manufacturer Narrative
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The lot history records and sterilization records were reviewed.The lot history information showed that the lot was sterilized acceptably, and that the device was manufactured and released according to the appropriate manufacturing procedures and relevant specifications.
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Search Alerts/Recalls
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