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Catalog Number UNKAA016 |
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 09/14/2015 |
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.Should additional information be provided, a supplemental emdr will be submitted.
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Event Description
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Attorney alleges that the patient underwent surgery for implant of unspecified bard/davol composix kugel hernia patch and phasix on (b)(6) 2009 and/or (b)(6) 2019.As reported, the patient is making a claim for an adverse patient outcome against the composix kugel hernia patch.It is alleged that the patient sustained injuries on (b)(6) 2015 and (b)(6) 2019.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.Note: due to the unavailability of phasix during the year 2009, the date of implant for composix kugel hernia patch was considered to be (b)(6) 2009 and phasix to be (b)(6) 2019.
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Search Alerts/Recalls
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