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Catalog Number UNKAA016 |
Device Problems
Defective Device (2588); Insufficient Information (3190)
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Patient Problems
Death (1802); Injury (2348)
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Event Type
Death
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Manufacturer Narrative
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At this time no conclusions can be made.The patient's attorney alleges surgical intervention and death; however, no details have been provided.No medical records, autopsy, or death certificate 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 composix kugel (device #1).An additional emdr was submitted to represent the bard/davol bard flat mesh (device #2).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 on (b)(6) 2011, the patient underwent surgery for implant of an unspecified bard/davol composix kugel hernia patch (device #1) and an unspecified bard/davol marlex (device #2).It is alleged that the patient had subsequent surgical intervention due to the hernia mesh device.As reported, the patient is making a claim for an adverse patient outcome against the composix kugel (device #1) and marlex (device #2).As reported, the attorney alleges wrongful death, the product is defective and that the patient experienced emotional distress.
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Search Alerts/Recalls
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