SRS MEDICAL THE SPANNER TEMPORARY PROSTATIC STENT; STENT, URETHRAL, PROSTATIC, SEMI-PERMANENT
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Model Number SPNR-9HA |
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 12/23/2014 |
Event Type
Injury
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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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Event Description
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A temporary prostatic stent was placed by a urologist on (b)(6) 2014 in a patient that had been performing intermittent self-catheterization.On (b)(6) 2014, the patient reported that the stent was expelled during a void.The patient returned to performing intermittent self-catheterization.There was no reported injury but it is believed that the patient was unable to void without catheterization.
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