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Catalog Number UNKAA077 |
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 04/25/2018 |
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 of the patient, surgical intervention due to the hernia mesh and 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 plaintiff"; 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 mesh - ventralex (device #1).An additional emdr was submitted to represent the composix mesh e/x (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/davol ventralex on (b)(6) 2004 and composix e/x on (b)(6) 2006.As reported, the plaintiff is making a claim for an adverse patient outcome against both devices.It is alleged that the patient had revision surgery on (b)(6) 2018.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 plaintiff." it is also alleged that the plaintiff experienced emotional distress and the device was defective.
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Search Alerts/Recalls
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