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Catalog Number UNKAA081 |
Device Problems
Defective Device (2588); Patient Device Interaction Problem (4001)
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Patient Problem
Insufficient Information (4580)
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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; 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 #4).Additional emdrs were submitted to represent the bard/davol ventralex st patch (device #1), bard/davol ventralight st (device #2) and bard/davol ventrio st (device #3).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 ventralex st patch, ventralight st, ventrio st and xenmatrix on (b)(6) 2012 and/or (b)(6) 2014 and/or (b)(6) 2015 and/or (b)(6) 2016.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 experienced emotional distress and the device was defective.
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Search Alerts/Recalls
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