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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
Event Date 01/06/2020
Event Type  Injury  
Manufacturer Narrative

The device is not available for analysis. The device history record (dhr) confirmed that the devices met all material, assembly and performance specifications. 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 available, an evaluation conclusion code of known inherent risk of the device was assigned to this investigation.

 
Event Description

It was reported that the patient underwent convective radiofrequency water vapor thermal therapy procedure of the prostate. During the procedure the patient was given prostate block or epidural, anxiety medication and pain medication. A total of 9 treatments were delivered. There were no device observations or adverse event during procedure. The patient was reported to be giving throughout treatment valium 10m, oxycodone, acetaminophen 5/325mg, pyridium 200mg, bactrim 160/800mg. It was reported that 4 days post procedure the patient experienced constipation, hematuria/pericatheter bleeding and pain with urination. The patient was given prune juice for the constipation. There was no treatment administered for the patient symptoms of hematuria/pericatheter bleeding and pain with urination. The hematuria/pericatheter bleeding and pain with urination symptoms resolved 4 days post onset symptoms. The constipation symptom resolved 10 post onset symptom. The patient symptoms were reported to be probable related to procedure and unlikely related to the device.

 
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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 Key9772646
Report Number2937094-2020-00204
Device Sequence Number1
Product CodeKNS
Report Source Manufacturer
Source Type STUDY,USER FACILITY
Reporter Occupation
Type of Report Initial
Report Date 02/29/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/29/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date04/30/2020
Device MODEL NumberD2201
Device Catalogue NumberD2201
Device LOT Number2019041262
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 Received02/10/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured05/22/2019
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: 02/29/2020 Patient Sequence Number: 1
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