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Catalog Number 810081 |
Device Problem
Material Perforation (2205)
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Patient Problems
Internal Organ Perforation (1987); Surgical procedure (2357); Therapy/non-surgical treatment, additional (2519)
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Event Date 04/28/2014 |
Event Type
Injury
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Event Description
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It was reported that a patient underwent an unknown surgical procedure on (b)(6) 2014 and mesh was implanted.During the procedure, the urethra was perforated by the mesh.The mesh was removed and the patient was administered a catheter for 14 days.After 14 days with the catheter, a cystoscopy was performed and the patient was reported as okay.Following the cystoscopy, the patient underwent a surgical procedure with mesh.Additional information has been requested.
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Manufacturer Narrative
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(b)(4).No conclusion can be drawn at this time.Should additional information be obtained, a supplemental 3500a form will be submitted accordingly.In addition, 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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