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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 Problem Incontinence (1928)
Event Date 09/01/2019
Event Type  Injury  
Manufacturer Narrative
This report is for the same patient procedure as manufacturer report: 2937094-2019-61241.
 
Event Description
The patient underwent convective radiofrequency water vapor thermal therapy procedure. The patient was given iv sedation, pain medication, and general anesthesia. During procedure, a total of 12 treatments were delivered. There were no device observations or adverse events during the procedure. The subject was discharged with an indwelling catheter and removed seven days post procedure. It was reported that at 35 days post the index procedure, the patient is experiencing intermittent worsening urge incontinence that is still ongoing. No treatment has been administered in response to the patient symptom. The facility investigator assessed the worsening urge incontinence patient symptom as possible related to the procedure and 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 Key9319160
MDR Text Key166624674
Report Number2937094-2019-61532
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
Report Date 08/24/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/13/2019
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 Received07/30/2020
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: 11/13/2019 Patient Sequence Number: 1
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