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Catalog Number UNKAA081 |
Device Problems
Defective Device (2588); Insufficient Information (3190)
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Patient Problem
Injury (2348)
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Event Type
Injury
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Manufacturer Narrative
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At this time no conclusions can be made.The patient's attorney alleges that the patient had subsequent surgical intervention; however, no details have been provided.No lot number has been provided; therefore, a review of the manufacturing records is not possible.This emdr represents the bard/davol xenmatrix (device #3).Additional emdrs were submitted to represent bard/davol composix (device #1), bard/davol marlex (device #2) and bard/davol composix (device #4).Should additional information be provided a supplemental emdr will be submitted.Not returned.
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Event Description
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Attorney alleges that the patient underwent surgery for implant of unspecified bard/davol composix, marlex (bard flat mesh) and xenmatrix in 2004, 2005, 2008 and 2010.As reported, the patient is making a claim for an adverse patient outcome against all devices.Attorney alleges that the patient had subsequent surgical intervention due to the hernia mesh device.It is also alleged that the patient experienced emotional distress and the device was defective.
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Search Alerts/Recalls
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