SRS MEDICAL THE SPANNER TEMPORARY PROSTATIC STENT; STENT, URETHRAL, PROSTATIC, SEMI-PERMANENT
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Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Urinary Retention (2119)
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Event Date 09/13/2014 |
Event Type
Injury
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Event Description
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A temporary prostatic stent was placed by a urologist on (b)(6) 2014.On (b)(6) 2014, the patient reported urinary retention and the urologist removed the stent without incident.There was no reported patient injury but the stent did not alleviate the patient's urinary retention symptoms.
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Manufacturer Narrative
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When this event was initially received, our procedures for determining mdr did not characterize this event as reportable in accordance with 21 cfr 803.3(w).We have recently revised our procedures to broaden the interpretation of 21 cfr 803.3(w)(3) and are retrospectively reporting previous events dating back to 2013.
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Search Alerts/Recalls
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