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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDPLAST MEDICAL, INC. REZUM UNIT, ELECTROSURGICAL ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)

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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 Urinary Retention (2119); Urinary Tract Infection (2120)
Event Date 08/02/2018
Event Type  Injury  
Manufacturer Narrative
The device is not available for analysis. A review of the device 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 the information currently available, the reported patient symptoms are known risk associated with this type of procedure. An evaluation conclusion code of known inherent risk of the device was assigned to this investigation this report is for the same event as manufacturer report: 2937094-2019-60909.
 
Event Description
It was reported that 9 days post convective radiofrequency water vapor thermal therapy procedure, the patient experienced an urinary tract infection (uti) and acute urinary retention. The patient was administered medication (unknown type and dose) for the uti, and was catheterized for the acute urinary retention. The acute urinary retention symptom resolved 5 days post onset symptom and the uti resolved 10 days post onset symptom. At 33 days post resolving the uti, the patient experienced uti once more. The patient was treated with medication (unknown type and dose) resolving the uti 25 days post onset symptom. At 77 days post the index procedure, the patient was reported to be experiencing epididymitis with testicular pain and edema. Medication (unknown type and dose) was administered resolving symptoms 10 days post onset symptoms. The assessment of the patient symptoms of acute urinary retention and uti were assessed as possibly related to the treatment and unlikely to the device. The patient symptoms of epididymitis with testicular pain and edema was assessed as probable related to the treatment and unlikely to the device. This report is for uti and urinary retention.
 
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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 Key8824568
MDR Text Key152166598
Report Number2937094-2019-60910
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
Report Date 02/29/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/24/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberD2201
Device Catalogue NumberD2201
Device Lot Number2019020011
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 Received02/17/2020
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: 07/24/2019 Patient Sequence Number: 1
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