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Catalog Number UNKAA081 |
Device Problems
Defective Device (2588); Patient Device Interaction Problem (4001)
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Patient Problems
Pain (1994); Insufficient Information (4580)
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Event Type
Injury
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Manufacturer Narrative
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No conclusions can be made.The patient's attorney alleges "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"; 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 the bard/davol ventralight st mesh (device #1) and the bard/davol phasix mesh (device #2).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 ventralight st, phasix and xenmatrix surgical graft on (b)(6) 2021 and/or (b)(6)2021.As reported, the patient is making a claim for an adverse patient outcome against all devices.Attorney also alleges that the patient sustained injuries on (b)(6) 2021 and (b)(6) 2021.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." 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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