Model Number PCDH1 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Abscess (1690); Adhesion(s) (1695); Inflammation (1932); 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.
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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) 2010 and mesh was implanted.It was reported that the patient underwent revision and removal on (b)(6) 2021 during which the surgeon noted a right upper quadrant 5 mm umbilical port.Dissection was then carried down toward the pelvis.The patient had a 12 cm in width recurrent incisional hernia.The bowel was carefully taken out of the incisional hernia with sharp dissection.The patient then had more significant adhesions to the prior placed intra-abdominal mesh.About 1 hour spent with attempted laparoscopic lysis of adhesions.Bowel was taken off the mesh laparoscopy however, a small bowel injury occurred during this time.The procedure was converted to open.All adhesions were taken down sharply with scissors.The patient had a large abscess cavity in the left lateral abdominal wall which was entered and fully cleaned out.Upon entry to this cavity, a 15x20 cm piece of old mesh was found completely non adherent to the abdominal wall and was removed.It was reported that the patient experienced severe pain and inflammation.It was reported that the patient had a previous mesh implanted on (b)(6) 2008 which is captured in a separate file.No additional information was provided.
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Manufacturer Narrative
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Date sent to the fda: 02/22/2023.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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