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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 Inflammation (1932); Pain (1994); Urinary Retention (2119); Urinary Tract Infection (2120); Hematuria (2558); Dysuria (2684); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 10/26/2021
Event Type  Injury  
Manufacturer Narrative
The exact event date is unknown. The date reflected is based on an approximate 6 weeks from the patient's report to bsc and applying the internal guidance. (b)(6).
 
Event Description
Boston scientific became aware of a patient experience with rezum on (b)(6) 2021. The patient reported that he underwent a water vapor therapy procedure approximately 6 weeks ago, and to date, the patient is unable to urinate most time of the day without extreme pain. The patient ended up with a catheter for almost two weeks and made two trips to the local emergency room; the first time was due to being unable to urinate at all and the second time was due to extreme pain when urinating. Even after 6 weeks post water vapor therapy procedure, the patient is still experiencing some bleeding with urination. For the first time since the water vapor therapy procedure, the patient had intercourse and reported that his orgasm, while painful, was also dry. The patient also recently developed epididymitis and was prescribed antibiotic that resulted in hives. The patient acknowledges that his condition may be unusual, but he believes boston scientific (bsc) literature does not advise adequately regarding the risks and complications that can result from water vapor therapy procedure. The patient does not know when he can expect to begin to feel better but he does know that the past 6 weeks have been a very negative life changing experience.
 
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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
4089353452
MDR Report Key13028623
MDR Text Key282483462
Report Number2124215-2021-38247
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,Health Professional
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 01/11/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/17/2021
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 Received12/27/2021
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: 12/17/2021 Patient Sequence Number: 1
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