MAUDE Adverse Event Report: MEDPLAST MEDICAL, INC. REZUM; UNIT, ELECTROSURGICAL ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)

Model Number D2201

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Urinary Retention (2119)

Event Date 01/14/2019

Event Type  Injury  

Event Description

It was reported by the physician approximately 22 days post water vapor thermal therapy of the prostate, that the patient was still experiencing urine retention and was still catheterized.It was further clarified that the patient was not in urinary retention prior to the procedure.The physician later reported that the patient was doing fine and was no longer catheterized.

• Brand Name: REZUM
• Type of Device: UNIT, 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 Key: 8388533
• MDR Text Key: 137792971
• Report Number: 2937094-2019-60279
• Device Sequence Number: 1
• Product Code: KNS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K180237
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: D2201
• Device Catalogue Number: D2201
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/04/2019
• Initial Date FDA Received: 03/04/2019
• 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 Sequence Number: 1
• Patient Outcome(s): Other