COLOPLAST A/S X-FLOW PROSTATECTOMY CATHETER; INDWELLING URETHRAL DRAINAGE BALLOON CATHETER, NON-ANTIMICROBIAL
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Catalog Number AB6118 |
Device Problem
Material Rupture (1546)
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Patient Problems
Pain (1994); Urinary Retention (2119)
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Event Date 10/11/2023 |
Event Type
malfunction
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Event Description
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According to the available information after placement of the catheter, after surgery, the balloon ruptured.A second catheter was placed; however, this balloon also ruptured.The patient experienced pain during removal of each catheter, and also experienced urinary retention.
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Manufacturer Narrative
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The lot number was reported to be one of the following lots: 8341166, 8765612, 8559602, 9102872 or 8839826.The specific lot involved was unknown.
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Event Description
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According to the available information after placement of the catheter, after surgery, the balloon ruptured.A second catheter was placed; however, this balloon also ruptured.The patient experienced pain during removal of each catheter, and also experienced urinary retention.
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Manufacturer Narrative
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After receiving this complaint, we searched for other complaints and we found none regarding the lot number 8341166.In october, we received one used sample with balloon burst.After disinfection we noticed that the balloon was burst.A similar case study was performed based on same item number ab61, same defect: balloon burst, over last four year; 5 similar cases were found.
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Search Alerts/Recalls
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