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Catalog Number UNKAA018 |
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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Event Description
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Attorney alleges that the patient underwent surgery for implant of unspecified bard/davol composite mesh (composix) and composix kugel hernia patch on (b)(6) 2003 and/or (b)(6) 2005.As reported, the patient is making a claim for an adverse patient outcome against both the 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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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 mesh ¿ composix (device #1).An additional emdr was submitted to represent the bard/davol mesh ¿ composix kugel (device #2).Should additional information be provided, a supplemental emdr will be submitted.
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Search Alerts/Recalls
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