Catalog Number PHY2025V |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Adhesion(s) (1695); Inflammation (1932); Necrosis (1971); Pain (1994); Hernia (2240); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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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.
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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) 2012 and mesh was implanted.It was reported that the patient underwent removal surgery on (b)(6) 2012 during which the surgeon noted ¿he lysed an extensive amount of small bowel and omental adhesions to the mesh which necessitated a small bowel resection.While removing the mesh, the surgeon drained a sizeable abscess cavity.¿ it was reported the patient experienced severe pain, nausea, diarrhea and inflammation.No additional information was provided.
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Manufacturer Narrative
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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: 5/23/2021.Additional h6 clinical code: e19.H6: appropriate term / code not available (e2402) utilized to capture meshoma.Additional b5 narrative: it was reported that the patient experienced infection, hernia recurrence, necrosis, meshoma following the surgery.Date sent to the fda: 5/23/2021.Corrected b5 narrative: it was reported that the patient underwent mesh removal on (b)(6) 2012.
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Search Alerts/Recalls
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