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 #2).An additional emdr was submitted to represent the bard/davol sepramesh composix ip (device #1).Should additional information be provided, a supplemental emdr will be submitted.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.
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Attorney alleges that the patient underwent surgery for implant of unspecified bard/davol sepramesh composite ip and xenmatrix on (b)(6) 2011.As reported, the patient is making a claim for an adverse patient outcome against both devices.It is alleged that the patient had injury on (b)(6) 2011.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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