ETHICON INC. TENSION FREE VAGINAL TAPE - OBTURATOR UNKNOWN PROD; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC
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Lot Number 3936368 |
Device Problem
Migration (4003)
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Patient Problems
Bacterial Infection (1735); Erosion (1750); Incontinence (1928); Pain (1994); Ambulation Difficulties (2544)
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Event Date 03/01/2021 |
Event Type
Injury
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Event Description
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It was reported that a patient underwent a sling procedure on (b)(6) 2021 and mesh was implanted.The patient reported that in the wake-up room, they couldn't feel the left leg anymore.In the days following the operation, the patient felt pain inside the thighs above the adductors and still had urine leakage.The patient understood that it was pain in the obturator muscles and pain in the stomach.When putting on cream for post-operative healing, the patient felt something rough in the back of the vagina.The strip punctured the vagina.The patient had surgery and the surgeon cut the end of the strip.The pains did not go away, nor discomfort during sex.The piece of strip was analyzed and contaminated with a bacterium "streptococcus anginous multi-sensitive".From this operation, the patient had trouble taking long walks.Some days, the patient limped and stabbed in the stomach.The patient felt the strip all the time in the lower abdomen.The patient reported currently experiencing obturator muscle pain, leg pain with feeling of cramps, stomach pain, pain during sexual intercourse, urinary leakage always present and bacteria present many weeks despite treatment.Then the strip was removed by another surgeon on (b)(6) 2023.The operation was difficult but the strip was removed.The stomach pain has disappeared.The patient still has pain in the obturator muscles especially the right, and electric blows and cramps in the legs especially the right.The patient has done tests and it's not circulatory pain.Some movements hurt and intensive walking also triggers pain in the right shutter.No further information is available as the reporter contact details were not disclosed.
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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.Related events captured via 2210968-2024-01820, 2210968-2024-01821 and 2210968-2024-01822.
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