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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 Problem Discomfort (2330)
Event Date 02/01/2020
Event Type  Injury  
Manufacturer Narrative
Date of event: actual event date is unknown.
 
Event Description
It was reported by a patient that during a conversation with a home health nurse about his convective radiofrequency water vapor thermal therapy treatment experience, that she heard from another patient forcing the doctor to stop treatment after only three of the nine seconds injection of steam delivered.No further information was available.
 
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 causes and controls for complaints related to the clinical event were identified.Based on the information available, an evaluation conclusion code of known inherent risk of device was assigned to this investigation.
 
Event Description
It was reported by a patient that during a conversation with a home health nurse about his convective radiofrequency water vapor thermal therapy treatment experience, that she heard from another patient forcing the doctor to stop treatment after only three of the nine seconds injection of steam delivered.No further information was available.
 
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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 Key9782271
MDR Text Key181842249
Report Number2937094-2020-00207
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 consumer
Type of Report Initial,Followup
Report Date 03/27/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/03/2020
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 Received03/27/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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