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Model Number 810081 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Pain (1994); Ambulation Difficulties (2544)
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Event Date 09/28/2009 |
Event Type
Injury
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Manufacturer Narrative
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(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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Event Description
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It was reported that a patient underwent a sling procedure on (b)(6) 2009 and mesh was implanted.The patient reported pain in the groin, legs and back with more strength in the left leg along with difficulty walking and climbing stairs.No further information is available.
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Search Alerts/Recalls
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