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

MAUDE Adverse Event Report: MEDPLAST MEDICAL, INC. 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
 

MEDPLAST MEDICAL, INC. 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 Incontinence (1928); Muscle Spasm(s) (1966); Urinary Tract Infection (2120)
Event Date 05/22/2019
Event Type  Injury  
Event Description
The patient was administered iv sedation, pain medication and general anesthesia. A total of 15 treatments were delivered. No adverse event occurred during the procedure. It was reported that at 2 days post convective radiofrequency water vapor thermal therapy procedure, the patient was experiencing intermittent bladder spasms. The patient described the pain as a cramping sensation in his lower abdomen extending into his penis. The patient self treated with ibuprofen 600mg. The patient was discharged with an indwelling catheter, which was removed 8 days post the index procedure. At 8 days post procedure, the patient was reported to be experiencing intermittent worsening of urge incontinence. There was no treatment administered for this symptom. At 14 days post the index procedure, the patient was reported to be experiencing an urinary tract infection (uti) for which urine culture tested positive. The patient was treated with 500mg of levaquin. The investigator assessment for the symptoms of worsening or urge incontinence, bladder spasms and uti were assessed as probable related to the procedure and device.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameREZUM
Type of DeviceUNIT, ELECTROSURGICAL ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)
Manufacturer (Section D)
MEDPLAST MEDICAL, INC.
5079 33rd street se
grand rapids MI 49512
Manufacturer (Section G)
MEDPLAST MEDICAL, INC.
5079 33rd street se
grand rapids MI 49512
Manufacturer Contact
alyson harris
150 baytech drive
san jose, CA 95134
4089353452
MDR Report Key8769418
MDR Text Key150384303
Report Number2937094-2019-60839
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 study,user facility
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 06/14/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/08/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date10/31/2019
Device Model NumberD2201
Device Catalogue NumberD2201
Device Lot Number2018101664
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 Received05/28/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/08/2018
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: 07/08/2019 Patient Sequence Number: 1
-
-