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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
Model Number D2201
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Fever (1858); Micturition Urgency (1871); Incontinence (1928); Sepsis (2067); Urinary Tract Infection (2120); Chills (2191)
Event Date 12/02/2019
Event Type  Injury  
Event Description
It was reported by the patient that during convective radiofrequency water vapor thermal therapy, the injection of lidocaine though patients body released e-coli into bloodstream resulting in rigor, high fever and sepsis. The hospitalization came as a result three days post the procedure. The patient was put under fourteen days of heavy antibiotics infusion. Six months post the procedure, the patient still had benign prostatic hyperplasia (bph) and traces of e-coli in urine. The patient had two to three trips to urinate at night after falling asleep and the urine flow was very weak. The patient had bladder retention, getting up to urinate two or three times a night, erratic pressure flow, incontinence (urine leakage during the day). It was also reported by the patient that he had a terrible experience and to date poor results. The symptoms were same as before the procedure.
 
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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 CORPORATATION
300 boston scientific way
marlborough MA 01752
Manufacturer Contact
alyson harris
150 baytech drive
san jose, CA 95134
4089353452
MDR Report Key10192317
MDR Text Key197020818
Report Number2937094-2020-00527
Device Sequence Number1
Product Code KNS
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K180237
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/29/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/24/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberD2201
Device Catalogue NumberD2201
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/06/2020
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: 06/24/2020 Patient Sequence Number: 1
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