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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION REZUM UNIT, ELECTROSURGICAL ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)

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BOSTON SCIENTIFIC CORPORATION REZUM UNIT, ELECTROSURGICAL ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES) Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Hemorrhage/Bleeding (1888); Urinary Retention (2119)
Event Date 06/30/2022
Event Type  Injury  
Event Description
It was reported that a patient with an urinary retention medical history, underwent a water vapor thermal therapy procedure. Six days after the procedure, the patient had an appointment in which a catheter was removed and a new one was placed. Upon removal, some blood was seen in the head of the penis and the urethral entrance. Following this appointment, the patient still experienced bleeding and pressure when sitting down. The physician scheduled a nurse to replace the catheter in a home visit; however, the patient cancelled the appointment and contacted the physician again. The patient believed the procedure did not work because he could not urinate by himself.
 
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Brand NameREZUM
Type of DeviceUNIT, ELECTROSURGICAL ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
300 boston scientific way
marlborough MA 01752
Manufacturer (Section G)
BOSTON SCIENTIFIC CORPORATION
300 boston scientific way
marlborough MA 01752
Manufacturer Contact
alyson harris
4100 hamline avenue north
building c
saint paul, MN 55112
MDR Report Key15080277
MDR Text Key296369199
Report Number2124215-2022-26887
Device Sequence Number1
Product Code KNS
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/26/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/21/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received08/04/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 07/21/2022 Patient Sequence Number: 1
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