(b)(4).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.(b)(4)- device not returned.A manufacturing record evaluation was performed for the finished device batch, and no non-conformances were identified.
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It was reported that a patient underwent a sling procedure on (b)(6) 2019 and mesh was implanted.The patient reported experiencing severe pain immediately after in the groin, buttock and left leg with difficulty walking.The patient further reported pain in the 2 groins radiating in the front of the legs, difficulty sitting for a long time due to groin pain, stomach pain, pain during intercourse, impression of feeling the mesh in the groin and occasional internal burning sensation in the pubis.No further information is available.
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