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Catalog Number UNKAA053 |
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 an unspecified bard/davol composix kugel hernia patch and perfix plug on (b)(6) 2007 and/or (b)(6) 2007.As reported, the patient is making a claim for an adverse patient outcome against the both 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." attorney alleges that the patient experienced emotional distress and the device was defective.Note: the date of implant for composix kugel hernia patch provided in the initial legal claim was (b)(6) 2007.Therefore, the date of implant for the perfix plug will be considered as (b)(6) 2007.
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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 perfix plug (device #2).An additional emdr was previously submitted to represent the bard/davol mesh ¿ composix kugel (device #1).Should additional information be provided, a supplemental emdr will be submitted.
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Search Alerts/Recalls
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