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Catalog Number UNKAA081 |
Device Problems
Defective Device (2588); Insufficient Information (3190)
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Patient Problems
Pain (1994); Injury (2348); Disability (2371)
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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 #1).Additional emdrs were submitted to represent the four bard/davol xenmatrix (device #2, device #3, device #4, device #5) and the bard/davol phasix st mesh (device #6).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 unspecified bard/davol xenmatrix on (b)(6) 2014 (x2), (b)(6) 2014, (b)(6) 2015 (x2) and phasix st on (b)(6) 2017.As reported, the patient is making a claim for an adverse patient outcome against all devices.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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