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Catalog Number PHY1520R |
Device Problem
Hole In Material (1293)
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Patient Problems
Adhesion(s) (1695); Pain (1994); No Code Available (3191)
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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 info 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 that a patient underwent an ipom procedure for an incisional hernia on an unknown date and mesh was implanted.After 4-5 weeks, the patient experienced violent pain which occurred after sex.The patient underwent reoperation and during the procedure it was found that half the mesh had torn and the other half adhered to the colon.The ingrown mesh part also showed adhesions.While disconnecting the mesh from the colon, the bowel was injured.Adhesiolysis with mesh explantation was performed.The explanted mesh was then sent to the pathology to examine for bacterial contamination.Another like device was used to complete the procedure.Additional information has been requested.
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Search Alerts/Recalls
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