Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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 Problem Hematuria (2558)
Event Date 03/01/2019
Event Type  Injury  
Manufacturer Narrative
Date of event: the exact date of the event was not reported.
 
Event Description
It was reported via twitter that 8 weeks post convective radiofrequency water vapor thermal therapy procedure of the prostate, the patient experienced bleeding requiring catheter.Computed tomography urogram (ctu) showed clear defect extending to lateral lobes and toward bladder neck/median lobe.The hematuria stopped, and the catheter is out now, and patient "peeing like he was 30".No further information was provided.
 
Event Description
It was reported via twitter that 8 weeks post convective radiofrequency water vapor thermal therapy procedure of the prostate, the patient experienced bleeding requiring catheter.Computed tomography urogram (ctu) showed clear defect extending to lateral lobes and toward bladder neck/median lobe.The hematuria stopped, and the catheter is out now, and patient "peeing like he was 30".No further information was provided.
 
Manufacturer Narrative
Date of event the exact date of the event was not reported.The device is not available for analysis.A review of the rezum ifu and operators manual was completed and did not reveal any evidence of device misuse, off-label use, or failure to follow instructions.The potential cause and controls for complaints related to clinical events were identified.Based on review of the information available, hematuria is known risk associated with the use of the device and is noted as such in the instruction for use (ifu).An evaluation conclusion code of known inherent risk of the device was assigned to this investigation.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
REZUM
Type of Device
UNIT, ELECTROSURGICAL ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)
Manufacturer (Section D)
MEDPLAST MEDICAL, INC.
5079 33rd street se
grand rapids MI 49512
MDR Report Key8491499
MDR Text Key141198321
Report Number2937094-2019-60433
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 company representative
Type of Report Initial,Followup
Report Date 07/10/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/08/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model NumberD2201
Device Catalogue NumberD2201
Was Device Available for Evaluation? No
Date Manufacturer Received07/02/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
-
-