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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 Urinary Retention (2119); Blood Loss (2597); No Code Available (3191)
Event Date 03/05/2019
Event Type  Injury  
Event Description
It was reported that convective radiofrequency water vapor thermal therapy with rezum product was completed successfully with no clinical consequences to the patient. However, the patient went into urinary retention same day, post procedure, and went to the emergency room for catheter placement. Five days after catheter placement the patient was seen for catheter removal and patient passed void trial, however later the same day the patient was in retention and was admitted to urgent care. Patient was seen the next day for catheter removal and taught how to catheterize himself. Patient self catheterized for 9-14 days more day with improved retention however then the patient developed bleeding and was advised to minimize catheterizing. Patient continued to exhibit episodes of urinary retention and bleeding. The physician performed a cystoscopy in the office (placement of scope into the bladder to look for source of urine retention or bleeding) and found the prostate to appear "normal for just being vaporized". There was minimal amount of ooze at the bladder neck and no active bleeding noticed. Patient prescribed myrbetriq (medication used to treat overactive bladder). Bleeding and catheterization had stopped, however during a return flight from a business trip, from (b)(6), the patient exhibited severe bleeding, clot and urinary retention and the plane was diverted to (b)(6). Patient was taken to the hospital where "he" a catheter was placed and irrigated. A bleeder was found and the bleeder was cauterized to stop the bleeding. Patient's catheter was removed the next day with no observed bleeding however the following day bleeding reoccurred. The patient was readmitted and debating treatment options of cauterization or transurethral resection of the prostate (turp). The patient has not returned to the physician. The physician believes that the patient's symptoms are related the rezum treatment. Patient's current condition is unknown.
 
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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 Key8462575
MDR Text Key140336101
Report Number2937094-2019-60421
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
Report Date 03/28/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/28/2019
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 Received03/18/2019
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

Patient Treatment Data
Date Received: 03/28/2019 Patient Sequence Number: 1
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