Catalog Number PCDH1 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Abscess (1690); 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) 2018.Mwr-(b)(4) submitted for adverse event which occurred on (b)(6) 2018.
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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) 2018 and mesh was implanted.It was reported that the patient underwent removal surgery on (b)(6) 2018 and (b)(6) 2018 during which the surgeon noted ¿the mesh was loose deep into the incision and was excised.¿ it was reported that the patient experienced severe pain, abdominal wall abscess and wound exploration.No additional information is provided.
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Manufacturer Narrative
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Date sent to fda: 9/10/2020.Additional information: d1, d4, h4.A review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.
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Search Alerts/Recalls
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