Model Number PCDH1 |
Device Problem
Migration (4003)
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Patient Problems
Wound Dehiscence (1154); Erosion (1750); Purulent Discharge (1812); Hematoma (1884); Unspecified Infection (1930); Inflammation (1932); Pain (1994); Scar Tissue (2060)
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Event Type
Injury
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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 revision surgery on (b)(6) 2019 during which the surgeon noted there was a defect in the midportion of the mesh where he had debrided.He aspirated any purulent material from underneath the mesh there was minimal cavity.The area of exposed mesh in the depths of the incision was about 2 cm x 1 and.5 cm.It was reported that the patient experienced severe pain, inflammation, hematomas, infection, wound vac treatment, fascial dehiscence and mesh exposure.No additional information was provided.
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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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Manufacturer Narrative
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Date sent to the fda: 6/8/2022.Additional b5 narrative: it was reported that the patient experienced scarring.
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Manufacturer Narrative
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Date sent to the fda: 12/14/2022.Additional information: d4.
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Manufacturer Narrative
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Date sent to the fda: 01/02/2023.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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