Model Number 31201 |
Device Problem
Insufficient Information (3190)
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Patient Problems
Nausea (1970); Pain (1994); Vomiting (2144); Hernia (2240); No Code Available (3191)
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Event Date 09/21/2013 |
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.
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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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Manufacturer Narrative
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Corrected information in explant date.Additional information in age/date of birth, date of event, describe event or problem, initial reporter and evaluation codes.
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Event Description
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Plaintiff presented to hospital for removal and repair of recurrent umbilical hernia since her surgery the year before.Allegedly, plaintiff experienced abnormal pain with nausea and vomiting.
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Event Description
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Allegedly patient was diagnosed with an umbilical hernia while she was pregnant and had the repair nine months later.She allegedly continued to experience pain, nausea and vomiting and was found to have a recurrence with incarceration of her hernia requiring additional surgery.
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Search Alerts/Recalls
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