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Catalog Number PFRT01 |
Device Problem
Appropriate Term/Code Not Available (3191)
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Patient Problem
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Type
Injury
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Manufacturer Narrative
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(b)(4).This emdr represents supplemental report # (b)(4) for previously submitted mdr number 2210968-2018-72276, subject of a litigation complaint summary exemption no.E2013037.The referenced exemption was revoked effective may 15, 2019.To date, the device has not been returned.If the product is returned for evaluation, any further information derived from the evaluation will be submitted in a supplemental 3500a form.A review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.
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Event Description
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It was reported that the patient underwent a gynecological surgical procedure on (b)(6) 2007 and prolift & tvt secur was implanted.It was reported that she experienced undisclosed injuries.It was reported that the patient underwent a revision surgery on an unknown date.No additional information was provided.
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Search Alerts/Recalls
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