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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 Thrombosis (2100); Urinary Retention (2119); Hematuria (2558); Dysuria (2684); Patient Problem/Medical Problem (2688)
Event Date 08/15/2019
Event Type  Injury  
Event Description
During procedure the patient was administered epidural, anti-anxiety and pain medication. A total of 8 treatments were delivered. There were no adverse events and no device observation noted. The same day post procedure, the patient was reported to be experiencing blood clots in urine and dysuria. The patient was discharged with an indwelling catheter which was removed 7 days post the index procedure. At 14 days post procedure the patient was reported to be experiencing elevated post void residual. The patient elevated post void residual resolved the same day. At 21 days post the index procedure, the patient was hospitalized due to intermittent blood clots in urine. A cystourethroscopy with irrigation/evaluation was performed in response to the blood clots in urine. The patient blood clot in urine resolved 49 days post onset symptom. The patient dysuria symptom is still on going. The investigator assessment of all three patient symptoms were assessed as probable procedure related and unlikely 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 e
grand rapids MI 49512
Manufacturer Contact
alyson harris
150 baytech drive
san jose, CA 95134
4089353452
MDR Report Key9240731
MDR Text Key163835560
Report Number2937094-2019-61431
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 07/15/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/25/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberD2201
Device Catalogue NumberD2201
Device Lot Number2019041262
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 Received07/13/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/22/2019
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: 10/25/2019 Patient Sequence Number: 1
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