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Model Number PCDD1 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Wound Dehiscence (1154); Nausea (1970); Pain (1994); Hernia (2240)
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Event Type
Injury
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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) 2008.(b)(4) submitted for adverse event which occurred on (b)(6) 2008.(b)(4) submitted for adverse event which occurred on (b)(6) 2011.
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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) 2007 and mesh was implanted.It was reported that the patient underwent partial removal surgery and hernia repair surgery on (b)(6) 2008 and mesh was implanted during which the surgeon noted the mesh appeared to have dehisced from the fascia and was therefore resected along with a portion of the hernia sac.It was reported that the patient underwent revision surgery on (b)(6) 2008 and mesh was implanted.It was reported that the patient underwent recurrent hernia repair surgery on (b)(6) 2011 during which the surgeon noted three defects which were marsupialized into a single defect.Adhesions of the omentum to the undersurface of the fascia were taken down with cautery.It was reported that the patient experienced severe pain, nausea, diarrhea, chills, inflammation, loss of appetite and extreme weight loss.Other procedure is captured under separate files.No additional information was provided.
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Manufacturer Narrative
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Date sent to the fda: 08/29/2021.Additional information: a1, a2, b7, d3.Additional b5 narrative: it was reported that the patient experienced recurrent incisional hernia following surgery.
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Search Alerts/Recalls
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