Model Number PCDH1 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Abscess (1690); Purulent Discharge (1812); Inflammation (1932); Nausea (1970); Pain (1994); Chills (2191); Impaired Healing (2378)
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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) 2014 and mesh was implanted.It was reported that the patient underwent removal surgery on (b)(6) 2016 during which the surgeon noted he found and lysed extensive bowel and omental adhesions to the anterior abdominal wall where the mesh was located.It was reported that the patient underwent incision and drainage of abdominal wall abscess on (b)(6) 2016 during which the surgeon noted he drained the thick purulent fluid from the abscess cavity and applied a wound vac to the wound.It was reported that the patient underwent an excisional biopsy of the abdominal wall for a poorly healing chronic abdominal wound.He performed the biopsy of the chronically inflamed wound and placed a wound vac in the wound.It was reported that the patient underwent recurrent hernia repair surgery on (b)(6) 2020 during which the surgeon noted he performed a tedious takedown of omentum and bowel adhesions to the anterior abdominal wall on both sides of the incision for the length of the incision.It was reported that the patient experienced severe pain, inflammation, nausea and chills.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.(b)(4) submitted for adverse event which occurred on (b)(6) 2016.(b)(4) submitted for adverse event which occurred on (b)(6) 2016.(b)(4) submitted for adverse event which occurred on (b)(6) 2020.
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Manufacturer Narrative
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Date sent to the fda: 6/23/2022.
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Search Alerts/Recalls
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