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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 Unspecified Infection (1930); Necrosis (1971); Hematuria (2558)
Event Date 01/12/2022
Event Type  Injury  
Event Description
It was reported that the patient had a water vapor therapy procedure to treat his benign prostatic hyperplasia. The patient's prostate was larger than 50 grams, a large medium lobe and an inflatable penile prosthesis grade three. The patient stopped antiplatelet medication seven days prior to the procedure and resumed aspirin and plavix medication three days post procedure. The patient had a total of six treatments with the device. The patient also had an inflatable penile prosthesis(ipp) implanted and during the procedure, the urologist decided to put cannabidiol(cbd) around the ipp for three weeks. The patient removed his cbd after three weeks post procedure and was doing well and able to urinate after removing the cbd. Days later, the patient was admitted to the hospital due to excessive bleeding. The cystoscopy showed that the patient's prostate had shrunk, however, a massive necrotic tissue was over the prostate including the median and lateral lobe which caused the patient to bleed and the wound to be infected. The urologist used transurethral resection of the prostate (turp) to resect the necrotic tissue. The patient was discharged and the patient condition following the procedure was stable. There is no allegation on the device or the utilization of the device.
 
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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 Key13588754
MDR Text Key286050667
Report Number2124215-2022-05449
Device Sequence Number1
Product Code KNS
Combination Product (y/n)N
Reporter Country CodeMY
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional,User Facility
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/15/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/23/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberD2201
Device Catalogue NumberD2201
Device Lot Number0028081372
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/24/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/15/2021
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: 02/23/2022 Patient Sequence Number: 1
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