Catalog Number PHY1015V |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Adhesion(s) (1695); Hernia (2240); Injury (2348); Not Applicable (3189)
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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.
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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) 2012 and mesh was implanted.It was reported that the patient underwent hernia repair surgery on (b)(6) 2015 and mesh was implanted.It was reported the patient experienced an undisclosed adverse event.Other procedures are captured under separate files.No additional information was provided.
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Manufacturer Narrative
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Date sent to the fda: (b)(6) 2020.Additional information: d4, h4.H6: appropriate term / code not available (g07002) utilized to capture no device returned.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 the fda: 11/24/2020.Additional b5 narrative: it was reported that the patient experienced recurrent hernia and adhesions following surgery.It was reported that the patient underwent mesh removal on (b)(6) 2020 due to recurrent ventral incisional hernia, infection, adhesions, fistula, and pain.(b)(4) submitted for the adverse event which occurred on (b)(6) 2015.(b)(4) submitted for the adverse event which occurred on (b)(6) 2020.
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Search Alerts/Recalls
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