Catalog Number PHY1020V |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Adhesion(s) (1695); Fistula (1862); Injury (2348); Post Operative Wound Infection (2446); Not Applicable (3189)
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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.
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Event Description
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It was reported by an attorney that the patient underwent a hernia repair procedure on (b)(6) 2015 and mesh was implanted.It was reported the patient experienced an undisclosed adverse event.No additional information was provided.
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Manufacturer Narrative
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Date sent to fda: 06/02/2020.H6 patient code: 3189 - surgical intervention.It was reported that the patient underwent a mesh removal procedure on (b)(6) 2016.It was reported that the patient experienced abdominal wound infection following the procedure.No additional information was provided.A review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.
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Manufacturer Narrative
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Date sent to fda: 08/26/2020.Additional information: b7.Additional b5 narrative: it was reported that following the insertion the patient experienced adhesions and fistula.
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Search Alerts/Recalls
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