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Model Number GPSL |
Device Problem
Appropriate Term/Code Not Available (3191)
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Patient Problems
Hemorrhage/Bleeding (1888); Incontinence (1928); Pain (1994); Urinary Retention (2119); Urinary Tract Infection (2120); Urinary Frequency (2275)
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Event Type
Injury
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Manufacturer Narrative
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This emdr represents supplemental report # 2210968-2017-30545 for previously submitted mdr number 2210968-2017-30260, subject of a litigation complaint summary exemption no.E2013037.The referenced exemption was revoked effective may 15, 2019.The information included in this report was submitted outside the required timeframe due to the extended use of exemption e2013037 beyond its revoke date, as documented under (b)(4).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.
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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) 2003 and mesh was implanted.It was reported the patient underwent removal surgery on a unk date.It was reported that she experienced urinary tract infections, vaginal bleeding, mixed incontinence, nocturia, urinary retention, polyuria, pelvic pain, and dyspareunia.No additional information was provided.
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Search Alerts/Recalls
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