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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 Incontinence (1928); Pain (1994)
Event Date 04/01/2019
Event Type  Injury  
Manufacturer Narrative
Actual event date is unknown.
 
Event Description
It was reported by the patient that is experiencing excruciating pain and leakage three months post convective radiofrequency water vapor thermal therapy procedure.Follow up with the facility indicated that the device performed as intended during procedure.The facility was unable to provide the current status of the patient as the patient has not contacted the facility about the pain and leakage.No further information is available.
 
Event Description
It was reported by the patient that is experiencing excruciating pain and leakage three months post convective radiofrequency water vapor thermal therapy procedure.Follow up with the facility indicated that the device performed as intended during procedure.The facility was unable to provide the current status of the patient as the patient has not contacted the facility about the pain and leakage.No further information is available.
 
Manufacturer Narrative
Actual event date is unknown.The device is not available for analysis.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.
 
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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 Key8566919
MDR Text Key143667012
Report Number2937094-2019-60479
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 other
Type of Report Initial,Followup
Report Date 07/22/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/30/2019
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 Received07/02/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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