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Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Diarrhea (1811); Nausea (1970); Pain (1994); Chills (2191)
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Event Type
Injury
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Manufacturer Narrative
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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.(b)(4) submitted for adverse event which occurred on (b)(6) 2015.(b)(4) submitted for adverse event which occurred on (b)(6) 2019.
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Event Description
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It was reported by an attorney that the patient underwent hernia repair surgery on (b)(6) 2013 and mesh was implanted.It was reported that the patient underwent revision surgery on (b)(6) 2015.It was reported that the patient underwent removal surgery on (b)(6) 2019 during which the surgeon noted removed the adhesions and excised the foreign body mesh.It was reported that the patient experienced severe pain, nausea, diarrhea and chills.No additional information was provided.
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Search Alerts/Recalls
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