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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 Edema (1820); Micturition Urgency (1871); Inflammation (1932); Urinary Tract Infection (2120); Hematuria (2558); Patient Problem/Medical Problem (2688)
Event Date 12/14/2018
Event Type  Injury  
Event Description
It was reported that post the convective radiofrequency water vapor thermal therapy index procedure, the patient experienced intermittent swelling in urethra at 18 days, worsening of urgency at 39 days, and a single episode of urinary tract infection (uti) at 42 days. The patient was administered nitrofurantoin mono/mac-100 mg bid for the uti, and the symptom resolved. The patient symptoms of swelling in urethra and worsening of urgency resolved without treatment. The patient swelling in urethra was assessed as not related to the treatment and device. The patient symptoms of uti and worsening of urgency were assessed as probable related to the treatment and device. The clinical end point committee (cec) adjudicated the relationship for the swelling in urethra as possible related to the treatment and device. The worsening of urgency was adjudicated as probable related to the treatment and possible related to the device. The patient uti was adjudicated by the cec as a nonevent.
 
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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 Key8745495
MDR Text Key149548286
Report Number2937094-2019-60802
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,Followup
Report Date 06/24/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/28/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberD2201
Device Catalogue NumberD2201
Device Lot Number2018020319
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 Received06/24/2020
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: 06/28/2019 Patient Sequence Number: 1
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