Model Number PHSE |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Pain (1994); 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.Mwr- (b)(4) submitted for adverse event which occurred on (b)(6) 2014.Mwr- (b)(4) submitted for adverse event which occurred on (b)(6) 2014.
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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 hernia repair surgery on (b)(6) 2014 during which the surgeon noted adhesions.It was reported that the patient underwent removal surgery and hernia repair surgery on (b)(6) 2014.It was reported that the patient severe pain.No additional information was provided.
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Manufacturer Narrative
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Date sent to fda: 10/29/2020.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: 2/21/2021.Additional information: a2.
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Manufacturer Narrative
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Date sent to the fda: 03/12/2021.Additional information: a2, b7 date sent to the fda: 03/12/2021.Corrected information: d6a.Corrected b5 narrative: it was reported by an attorney that the patient underwent hernia repair surgery on (b)(6) 2013 and mesh was implanted.
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Search Alerts/Recalls
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