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Catalog Number UNKAA081 |
Device Problems
Defective Device (2588); Insufficient Information (3190)
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Patient Problem
Injury (2348)
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Event Type
Injury
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Manufacturer Narrative
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No conclusions can be made.The patient's attorney alleges adverse patient outcome associated with the hernia mesh used to treat the patient.The patient's attorney alleges that the patient had subsequent surgical intervention and sustained personal injury; 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 surgical graft (device #4).Additional emdrs were submitted to represent the bard/davol sepramesh ip (device #1), bard/davol phasix st (device #2), bard/davol phasix (device #3) and bard/davol sepramesh ip (device #5).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 unspecified bard/davol sepramesh ip, phasix st mesh, phasix mesh and xenmatrix surgical graft on (b)(6) 2013 and/or (b)(6) 2013 and/or (b)(6) 2016 and/or (b)(6) 2017 and/or (b)(6) 2018.As reported, the patient is making a claim for an adverse patient outcome against all devices.Attorney alleges that the patient had subsequent surgical intervention due to the hernia mesh device.It is also alleged that the patient sustained personal injury, experienced emotional distress and the device was defective.
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Search Alerts/Recalls
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