• 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
Model Number D2201
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Dehydration (1807); Impotence (1925); Incontinence (1928); Unspecified Infection (1930); Weakness (2145); Patient Problem/Medical Problem (2688)
Event Date 01/22/2020
Event Type  Injury  
Event Description
It was reported that three days post a convective radiofrequency water vapor thermal therapy procedure the patient went to the emergency room due to his blood pressure being 70/54. The patient was dehydrated and weak. Once the patient was stabilized it was discovered, that the patients creatinine level was 9. 8. The patient was admitted and hospitalized for six days. Per the patient, the physician is convinced that the kidney issues were a result of the procedure. The physician decided to observe the patient and release him when creatinine level reached 7. 2. The patient is still being monitored and the last blood test revealed that a 2. 9 creatinine level, which is still high, but manageable. The patient has also stated that his urine flow was good for a while, but it is now inconsistent. The urine flow is okay during the day but weaker at night, wake up every 2 hours to urinate, feels the urge to urinate, and many times barely makes it to the toilet before leaking urine. The patient has not been able to have an erection since the procedure. His urologist recommended cialis.
 
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
150 baytech drive
san jose, CA 95134
4089353452
MDR Report Key10399129
MDR Text Key202696122
Report Number2937094-2020-00710
Device Sequence Number1
Product Code KNS
Combination Product (y/n)N
PMA/PMN Number
K180237
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Type of Report Initial,Followup
Report Date 08/13/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/12/2020
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
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/20/2020
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: 08/12/2020 Patient Sequence Number: 1
-
-