ETHICON INC. TENSION FREE VAGINAL TAPE - OBTURATOR UNKNOWN PROD; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC
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Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Pain (1994); Ambulation Difficulties (2544); Unspecified Mental, Emotional or Behavioural Problem (4430)
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Event Date 07/29/2009 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon inc, or its employees that the report constitutes an admission that the product, ethicon inc, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.To date it has been reported that the device will not be returned.If the device or further details are received at a later date a supplemental medwatch will be sent.H6 component code: g07002 ¿ device not returned.
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Event Description
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It was reported that a patient underwent an unknown procedure on an unknown date and mesh was implanted.The patient reported that the mesh implant has caused many problems including inability to have intercourse, continuing mental anguish, physical problems, pelvic pain, chronic back pain, pelvic area feeling like a hook in the hips, leg and feet pain, inability to walk far and slow, extreme pain for months after and bruising all over the abdomen causing much pain over next 3-6 months as legs were affected badly making it difficult to walk.No further information is available as reporter details have not been disclosed (confidential).
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