ETHICON INC. PROLIFT PELVIC FLOOR REPAIR UNKNOWN PRODUCT; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC
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Device Problem
Migration (4003)
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Patient Problems
Erosion (1750); Pain (1994); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 03/05/2010 |
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.(b)(4) submitted for adverse event which occurred on unk date in 2013.(b)(4) submitted for adverse event which occurred on unk date in 2017.(b)(4) submitted for adverse event which occurred on unk date in 2019.(b)(4) submitted for adverse event which occurred on unk date in 2013.(b)(4) submitted for adverse event which occurred on unk date in 2017.(b)(4) submitted for adverse event which occurred on unk date in 2019.
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Event Description
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It was reported by an attorney that the patient underwent a gynecological surgical procedure on (b)(6) 2010 and two (2) mesh products were implanted due to prolapse.It was reported that the patient underwent a surgical procedure on an unknown date in 2013 due to organ descent.It was reported that the patient underwent a surgical procedure on an unknown date in 2017 due to prostheses pierced through the organs.It was reported that in (b)(6) 2019 the patient was hospitalized due to severe pain.It was reported that on an unknown date in 2019 the patient underwent removal of one of the prostheses.It was reported that the patient experienced severe pain, erosion, impossibility of eating (only liquid foods) and difficulty in bowel movement, urination and walking.No additional information was provided.No additional information was provided.
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