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Catalog Number TVTS4 |
Device Problem
Appropriate Term/Code Not Available (3191)
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Patient Problems
Incontinence (1928); Pain (1994)
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Event Type
Injury
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Manufacturer Narrative
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This emdr represents supplemental report # 2210968-2017-01162 for previously submitted mdr number 2210968-2017-00629, subject of a litigation complaint summary exemption no.E2013037.The referenced exemption was revoked effective may 15, 2019.The reports previously submitted as part of the exemption were not submitted in a format compatible with the public mdr database (maude)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 was reported that the patient underwent a gynecological surgical procedure on (b)(6) 2010 and tvt secur was implanted.It was reported that the patient underwent removal surgery on an unk date.It was reported that the patient experienced severe pelvic pain.It was reported that following the procedure patient experienced incontinence.No additional information was provided.
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Manufacturer Narrative
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This emdr represents supplemental report # 2210968-2017-01162 for previously submitted mdr number 2210968-2017-00629, subject of a litigation complaint summary exemption no.E2013037.The referenced exemption was revoked effective may 15, 2019.The reports previously submitted as part of the exemption were not submitted in a format compatible with the public mdr database (maude)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 was reported that the patient underwent a gynecological surgical procedure on (b)(6) 2010 and tvt secur was implanted.It was reported that the patient underwent removal surgery on an unk date.It was reported that the patient experienced severe pelvic pain.It was reported that following the procedure patient experienced incontinence.No additional information was provided.
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Search Alerts/Recalls
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