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Catalog Number UNKAA066 |
Device Problems
Defective Device (2588); Insufficient Information (3190)
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Patient Problems
Death (1802); Pain (1994); Injury (2348); Disability (2371)
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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 cause of the patient postoperative complications cannot be determined at this time.No lot number has been provided therefore a review of the manufacturing records is not possible at this time.Information is limited.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 sepramesh composite ip on (b)(6) 2017.As reported, the patient is making a claim for an adverse patient outcome against the sepramesh composite ip.As reported, the attorney 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.".
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Manufacturer Narrative
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At this time no conclusions can be made.The cause of the patient postoperative complications cannot be determined at this time.No lot number has been provided therefore a review of the manufacturing records is not possible at this time.Information is limited.Addendum: this is an addendum to the initial emdr submitted on 22-aug-2019.A new legal claim from a second attorney for the patient has alleged wrongful death of the patient and subsequent surgical intervention.Therefore, a supplemental emdr was submitted.Should additional information be provided a supplemental emdr will be submitted.
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Event Description
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Attorney alleges that the patient underwent surgery for implant of an unspecified bard/davol sepramesh composite ip on (b)(6) 2017.As reported, the patient is making a claim for an adverse patient outcome against the sepramesh composite ip.As reported, the attorney 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." addendum as per legal claim: attorney alleges that the patient underwent surgery for the implant of an unspecified bard/davol sepramesh ip on (b)(6) 2017.As reported, the plaintiff is making a claim for an adverse patient outcome against the sepramesh ip.Attorney alleges that the patient had wrongful death and 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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