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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 Hematoma (1884); Thrombosis (2100); Urinary Retention (2119); Complaint, Ill-Defined (2331)
Event Date 04/29/2019
Event Type  Injury  
Event Description
It was reported that six days post a convective radiofrequency water vapor thermal therapy procedure of the prostate, the patient had a heart attack. It is unsure what the symptoms were but it was noted that the patient was straining to urinate and had bowel movement. The patient received a cardiac stent, anticoagulation therapy, and surgery for a suprapubic catheter due to a blood clot in the bladder. The patient was in and out of icu over the last 3 weeks and reported to have had surgery again (unknown cause) at 21 days post the index procedure. No further information is available.
 
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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 Key8685464
MDR Text Key147566512
Report Number2937094-2019-60689
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,Followup
Report Date 07/10/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/10/2019
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 Received07/09/2019
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

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