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Catalog Number UNKAA030 |
Device Problems
Defective Device (2588); Insufficient Information (3190)
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Patient Problems
Death (1802); Injury (2348); Disability (2371)
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Event Date 02/01/2006 |
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 wrongful death, general allegations for past, present and future damages, pain and suffering, permanent injury and 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 flat mesh (device #1).An additional emdr was submitted to represent the bard/davol composix kugel 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 the patient underwent surgery for implant of an unspecified bard mesh (bard flat mesh) on (b)(6) 2000 and bard/davol composix kugel hernia patch on (b)(6) 2006.As reported, the patient is making a claim for an adverse patient outcome against both the devices.Attorney alleges that the patient had revision surgeries on (b)(6) 2006 and (b)(6) 2019.Attorney alleges wrongful death of the patient on (b)(6) 2019.Attorney also alleges general allegations for ¿past, present, and future damages, including but not limited to, mental and physical pain and suffering for severe and permanent personal injuries sustained by the patient." the patient experienced emotional distress and the device was defective.
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Search Alerts/Recalls
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