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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 Hemorrhage/Bleeding (1888); Pain (1994); Urinary Retention (2119)
Event Date 01/01/2020
Event Type  Injury  
Manufacturer Narrative
Date of event: actual event date is unknown.
 
Event Description
It was reported that weeks after convective radiofrequency water vapor thermal therapy, the patient was rushed to the emergency room because the patient was experiencing a lot of pain in the bladder area.The patient was not able to empty his bladder.The emergency room (er) doctor was able to find that the patient had significant numbers of blood clots in his bladder.The patient was admitted for several hours.The patient was given several bags of saline and pain killers.The patient was discharged and the hospital assigned a nurse visit to his home for check-ups.The patient is fine now.
 
Manufacturer Narrative
Date of event: actual event date is unknown.The product was not returned so no physical analysis could be performed.A review of the device ifu and operators manual was completed and did not reveal any evidence of device misuse, off-label use, or failure to follow instructions.The potential cause and controls for complaints related to clinical events were identified.Based on the information currently available, the patient symptoms are known risk associated with this type of procedure.An evaluation conclusion code of known inherent risk of the device was assigned to this investigation.
 
Event Description
It was reported that weeks after convective radiofrequency water vapor thermal therapy, the patient was rushed to the emergency room because the patient was experiencing a lot of pain in the bladder area.The patient was not able to empty his bladder.The emergency room (er) doctor was able to find that the patient had significant numbers of blood clots in his bladder.The patient was admitted for several hours.The patient was given several bags of saline and pain killers.The patient was discharged and the hospital assigned a nurse visit to his home for check-ups.The patient is fine now.
 
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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
MDR Report Key9740799
MDR Text Key180403506
Report Number2937094-2020-00148
Device Sequence Number1
Product Code KNS
Combination Product (y/n)N
PMA/PMN Number
K180237
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Type of Report Initial,Followup
Report Date 03/15/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/21/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model NumberD2201
Device Catalogue NumberD2201
Was Device Available for Evaluation? No
Date Manufacturer Received03/10/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other; Required Intervention;
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