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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 Fever (1858); Patient Problem/Medical Problem (2688)
Event Date 09/01/2019
Event Type  Injury  
Event Description
It was reported that approximately two weeks post convective radiofrequency water vapor thermal procedure, the patient experienced fever.It was indicated that the fever was potentially caused as reaction on death adenom cells, but not confirmed.The fever of the patient and health status could be normalized within a few days with medication.It was further reported that the device was working correctly when used.The procedure was completed with the same device.The patient outcome was stable following the procedure.
 
Event Description
It was reported that approximately two weeks post convective radiofrequency water vapor thermal procedure, the patient experienced fever.It was indicated that the fever was potentially caused as reaction on death adenom cells, but not confirmed.The fever of the patient and health status could be normalized within a few days with medication.It was further reported that the device was working correctly when used.The procedure was completed with the same device.The patient outcome was stable following the procedure.
 
Manufacturer Narrative
Actual event date is unknown.The device was disposed of; therefore, analysis cannot 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, an evaluation conclusion code of known inherent risk of device was assigned to this event.
 
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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 Key9132599
MDR Text Key160525942
Report Number2937094-2019-61300
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 foreign,health professional,u
Type of Report Initial,Followup
Report Date 12/19/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/29/2019
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 Received12/12/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other; Required Intervention;
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