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Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Arthritis (1723); Incontinence (1928); Pain (1994); Rash (2033); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 12/23/2020 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).
Attempts are being made to obtain the following information.
to date no response has been provided.
If further details are received at a later date a supplemental medwatch will be sent.
If in your possession, may we have a copy of your operative report? does ethicon have your permission to contact your surgeon, in the event ethicon would like to contact your surgeon for more clinical information to be used for a product quality complaint investigation? if so, please provide your surgeon¿s name, contact information and sign release of medical information form attached.
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Event Description
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It was reported that a patient underwent a gynecological procedure on an unknown date in 2003 and the mesh was implanted.
It was reported that the patient had many issues since the mesh was implanted in 2003, including double incontinence, ibs, arthritis, pains all over the body, and rashes.
It was also reported that sitting down was painful for the patient and a cushion was required.
It was also reported that the patient couldn't sleep at night because of the pain.
It was reported that once the mesh was removed (it was doubled in half, sandwiched between the bowel and bladder) the patient became continent again.
The patient's arthritis has improved, and the patient no longer seems to have ibs.
It was reported that the mesh was removed on (b)(6) 2020.
Additional information was requested.
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Search Alerts/Recalls
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