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Catalog Number UNKAA030 |
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 Date 08/31/2012 |
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 flat mesh (device #3).Additional emdrs were submitted to represent the two bard flat meshes (device #1 and device #2).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 three unspecified bard meshes (bard flat mesh) on (b)(6) 2004, (b)(6) 2004 and (b)(6) 2005.As reported, the patient is making a claim for an adverse patient outcome against all devices.Attorney alleges that the patient sustained unspecified injuries on (b)(6) 2004, (b)(6) 2005 and (b)(6) 2012.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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