SRS MEDICAL THE SPANNER TEMPORARY PROSTATIC STENT; STENT, URETHRAL, PROSTATIC, SEMI-PERMANENT
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Model Number SPNR-6HA |
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 08/13/2018 |
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 in the office setting.On (b)(6) 2018, the patient reported accidentally pulling the stent's removal tether and removing the stent at home.A replacement stent was placed on (b)(6) 2018.There was no reported injury but it is believed that the patient was unable to void until the replacement stent was placed.
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