Catalog Number 810041B |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Calcium Deposits/Calcification (1758); Not Applicable (3189); No Code Available (3191)
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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 product is returned for evaluation, any further information derived from the evaluation will be submitted in a supplemental 3500a form.Mwr-24052019-0000439211 submitted for adverse event which occurred on (b)(6) 2013.Mwr-24052019-0000439212 submitted for adverse event which occurred on (b)(6) 2014.Report submission exceeding 30-days due to fdas exemption transitioning period.
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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) 2009 and mesh was implanted.It was reported that she experienced undisclosed injuries.It was reported that the patient underwent a revision surgery on (b)(6) 2013 and (b)(6) 2014.No additional information was provided.
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Manufacturer Narrative
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Stone formations.It was reported that the patient underwent a mesh revision due to calcification and stone formations.In addition, a review of the manufacturing records was performed and indicates that there were no quality concerns associated with the manufacturing process.
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Search Alerts/Recalls
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