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Model Number PMII |
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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This emdr represents supplemental report #(b)(4) for previously submitted mdr number 2210968-2018-72081.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 the referenced exemption was revoked effective may 15, 2019.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.A review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.(b)(4) submitted for adverse event which occurred on (b)(6) 2016.(b)(4) submitted for adverse event which occurred on (b)(6) 2017.(b)(4) submitted for adverse event which occurred on (b)(6) 2015.
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Event Description
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It was reported by an attorney that the patient underwent a gynecological surgical procedure to treat pelvic organ prolapse on (b)(6) 2007 and mesh was implanted.It was reported that she experienced undisclosed injuries.It was reported that the patient underwent removal surgery on (b)(6) 2015, (b)(6) 2016 and (b)(6) 2017.No additional information was provided.
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Search Alerts/Recalls
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