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Catalog Number UNKAA066 |
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 sepramesh ip (device #2).Additional emdrs were submitted to represent the bard/davol mesh ¿ composix (device #1) and the bard/davol ventralex st (device #3).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 composite mesh (composix) on (b)(6) 2003, sepramesh composite ip on (b)(6) 2011, ventralex st on (b)(6) 2017 and ventralight st on (b)(6) 2020.As reported, the patient is making a claim for an adverse patient outcome against composite mesh (composix), sepramesh composite ip and ventralex st.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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