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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 Anemia (1706); Muscle Spasm(s) (1966); Urinary Retention (2119); Discomfort (2330); Hematuria (2558); Blood Loss (2597); Patient Problem/Medical Problem (2688)
Event Date 06/01/2018
Event Type  Injury  
Event Description
The patient underwent convective radiofrequency water vapor thermal therapy of the prostate. The device performed as intended during the procedure. The patient tolerated the procedure and was sent home in stable condition with a catheter. It was reported that the patient proceeded to fail numerous voiding trials and experienced discomfort during voiding trials. In addition, the patient experienced severe bladder spasms and was unable to urinate. The patient ultimately developed severe gross hematuria and clot retention and needed to be transfused due to acute blood loss anemia. Due to the degree of discomfort, the patient underwent an emergency cystoscopy with clot retention procedure approximately two months post procedure. A large organized clot was evacuated from the patient bladder and a channel transurethral prostatic resection (turp) was performed as the patient had been unable to urinate since procedure. Patient was ultimately able to void but had continued bladder spasms and bothersome urinary symptoms. The physician had to perform a repeat turp two months later to alleviate the patient symptoms. The patient was reported to be doing well post treatments.
 
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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 Key8803193
MDR Text Key151456478
Report Number2937094-2019-60880
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 health professional,user faci
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/01/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/18/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberD2201
Device Catalogue NumberD2201
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 Received07/18/2019
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: 07/18/2019 Patient Sequence Number: 1
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