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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 Muscle Spasm(s) (1966); Urinary Retention (2119)
Event Date 07/17/2019
Event Type  Injury  
Event Description
The patient underwent the study procedure and was given a prostate block, epidural, anti-anxiety and pain medication. During procedure a total of 15 treatments were performed. No device observations or adverse events occurred during treatment. The same day post procedure, the patient experienced bladder spasms for which myrbetriq (dose unknown) was administered. The bladder spasm resolved 7 days post onset symptoms. At 7 days post the index procedure, the patient started experiencing urinary retention for which catherization was performed. The urinary retention resolved 20 days post onset symptom. The investigator assessment of the patient symptom of bladder spasms and urinary retention were assessed as definitely related to the procedure and not related to the device. The clinical end point committee (cec) adjudicated the patient bladder spasm and urinary retention as definite treatment related. The cec adjudicated the bladder spasm as possible device related and unlikely device related for the 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 Key9282226
MDR Text Key165246568
Report Number2937094-2019-61479
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 02/07/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/05/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date04/26/2021
Device Model NumberD2201
Device Catalogue NumberD2201
Device Lot Number2019020247
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 Received02/04/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/26/2019
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: 11/05/2019 Patient Sequence Number: 1
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