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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 Hemorrhage/Bleeding (1888); Incontinence (1928); Urinary Retention (2119); Hematuria (2558); Patient Problem/Medical Problem (2688)
Event Date 09/03/2019
Event Type  Injury  
Event Description
The patient underwent convective radiofrequency water vapor thermal therapy of the prostate. During procedure the patient was given iv sedation, pain medication and general anesthesia. A total of 12 treatments were delivered. No device observations or adverse events occurred during the procedure. The patient was discharged with an indwelling catheter which was removed 8 days post the index procedure. It was reported that on the 8th day post procedure, the patient was reported to be experiencing worsening hesitancy, worsening urinary incontinence, worsening dribbling urine (weak stream), incomplete emptying of bladder and hematuria. At 16 days post the index procedure, the patient was also reported to be experiencing hematospermia. The patient symptom of hematospermia resolved 20 days post onset symptom, and the hematuria resolved 28 days post onset symptoms, both, without medical treatment. The remaining patient symptoms are still ongoing and no treatment has been administered. The facility investigator assessed the patient symptoms to be possibly related to the procedure and not 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 Key9482871
MDR Text Key174399838
Report Number2937094-2019-61685
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,Followup
Report Date 10/12/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/17/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date11/30/2019
Device Model NumberD2201
Device Catalogue NumberD2201
Device Lot Number2018110702
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 Received09/17/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/18/2019
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: 12/17/2019 Patient Sequence Number: 1
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