• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

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 Urinary Tract Infection (2120); Urinary Frequency (2275); Cramp(s) /Muscle Spasm(s) (4521); Urinary Incontinence (4572)
Event Date 11/22/2021
Event Type  Injury  
Event Description
Boston scientific became aware of a patient experience post rezum procedure. The patient opted for rezum because it was a less invasive procedure. The patient underwent the procedure on (b)(6) 2021. The patient reports that it is past 3 months post procedure recovery period and is still experiencing incontinence and frequency symptoms. The patient has been on a series of antibiotics for urinary trat infection (uti) post procedure. In addition, the patient is taking meloxicam and vibegron and solifenacin (unknown dose) medications. The patient continued to experience leakage as well as frequency symptoms. Since the procedure the flow is much improve but the incontinence requires wearing a pad and shield. The patient expressed understanding of not seeing full improvement for three months; but did not expect to experience issues after three months.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key13777927
MDR Text Key287256567
Report Number2124215-2022-07523
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 04/06/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/16/2022
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 Received03/16/2022
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: 03/16/2022 Patient Sequence Number: 1
-
-