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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 Pain (1994); Renal Failure (2041); Urinary Retention (2119); Urinary Tract Infection (2120)
Event Date 09/01/2022
Event Type  Injury  
Event Description
It was reported by the patient that he had a water vapor therapy procedure three weeks ago and experienced post operative issues.He was admitted to the hospital and diagnosed with a urinary tract infection (uti), renal failure, urinary retention and was experiencing pain.
 
Manufacturer Narrative
Event date is approximate.
 
Manufacturer Narrative
B3: event date is approximate.There was no device available for analysis and there was no report of a device performance allegation during treatment.The reported patient symptoms are known risk associated with a water vapor therapy procedure as indicated in the instructions for use (ifu).The device is not available for analysis; therefore, no physical or visual analysis of the product could be performed.Based on the information available, a conclusion code of known inherent risk of device was assigned to this investigation.
 
Event Description
It was reported by the patient that he had a water vapor therapy procedure three weeks ago and experienced post operative issues.He was admitted to the hospital and diagnosed with a urinary tract infection (uti), renal failure, urinary retention and was experiencing pain.
 
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Brand Name
REZUM
Type of Device
UNIT, 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 Key15540906
MDR Text Key301151716
Report Number2124215-2022-39524
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 Other
Type of Report Initial,Followup
Report Date 10/31/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/04/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received10/20/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other; Hospitalization;
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