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Catalog Number PFRA02 |
Device Problem
Appropriate Term/Code Not Available (3191)
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Patient Problems
Unspecified Infection (1930); Pocket Erosion (2013); Urinary Tract Infection (2120)
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Event Type
Injury
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Manufacturer Narrative
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This emdr represents supplemental report # 2210968-2014-11380 for previously submitted mdr number 2210968-2014-08815, subject of a litigation complaint summary exemption no.E2013037.The referenced exemption was revoked effective may 15, 2019.The reports previously submitted as part of the exemption were not submitted in a format compatible with the public mdr database (maude) and are available through fda¿s mdr data files webpage, at https://www.Fda.Gov/medical-devices/medical-device-reporting-mdr-how-report-medical-device-problems/mdr-data-files#asr.Therefore, this report does not represent a new reportable event.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 is reported in the summons that the complainant underwent a procedure on (b)(6) 2011 in which a prolift device was inserted.Following the procedure she suffered vaginal infections, pelvic pain, urinary problems, recurrent urinary tract infections and dyspareunia.She underwent excision of exposed mesh.Urinary problems, pain, infection potentiation, and mesh exposure, erosion, or extrusion, are anticipated adverse event typically associated with implantable materials of this type and which is clearly identified within ethicon risk management documentation and also within the manufacturer¿s labeling.These events are well known and considered acceptable in terms of patient risk / benefit ratio.No additional information was provided.It is reported in the summons that the complainant underwent a procedure on (b)(6) 2011 in which a prolift device was inserted.Following the procedure she suffered vaginal infections, pelvic pain, urinary problems, recurrent urinary tract infections and dyspareunia.No additional information was provided.
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Search Alerts/Recalls
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