Catalog Number TVTS |
Device Problem
Migration or Expulsion of Device (1395)
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Patient Problems
Erosion (1750); Pain (1994); Scarring (2061); Not Applicable (3189)
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Event Type
Injury
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Manufacturer Narrative
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(b)(4).To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.In addition, a review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.Ethicon mdr summary reporting exemption (b)(4).Reporting period december 1, 2018 through january 31, 2018 total number of events ¿ 15 tension free vaginal tape ¿ secur - 15.
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Event Description
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It was reported by an attorney that the patient underwent a gynecological surgical procedure on (b)(6) 2011 and mesh was implanted.It was reported that she experienced pain, erosion of her internal bodily tissue, urinary problems, recurrence, dyspareunia, and vaginal scarring.It was reported that the patient has undergone multiple surgeries and revisionary procedures, including mesh removal on (b)(6) 2017.No additional information was provided.
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Manufacturer Narrative
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Ethicon mdr summary reporting exemption (b)(4).Reporting period (b)(4), 2018 through (b)(4) 2018.
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Manufacturer Narrative
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Ethicon mdr summary reporting exemption (b)(4).Reporting period december 1, 2018 through january 31, 2018.
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Manufacturer Narrative
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Date sent to fda: (b)(4) 2018.Ethicon mdr summary reporting exemption e2013037
reporting period (b)(4) 2018 through (b)(4) 2018.
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Manufacturer Narrative
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Ethicon mdr summary reporting exemption (b)(4).Reporting period december 1, 2018 through january 31, 2018.
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Manufacturer Narrative
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Date sent to fda: 02/12/2019.Ethicon mdr summary reporting exemption e2013037.Reporting period december 1, 2017 through january 31, 2018.
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Manufacturer Narrative
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Date sent to fda: 4/23/2019.Ethicon mdr summary reporting exemption e2013037.Reporting period december 1, 2018 through january 31, 2018.
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Search Alerts/Recalls
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