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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 Urinary Retention (2119); Urinary Tract Infection (2120); Discomfort (2330); Dysuria (2684)
Event Date 09/13/2018
Event Type  Injury  
Manufacturer Narrative
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.
 
Event Description
It was reported that the same day post convective radiofrequency water vapor thermal therapy procedure, the patient experienced urinary discomfort for which medication (unknown type and dose) was administered.Eight days post index procedure, the patient was reported to have experienced dysuria and urinary tract infection (uti).The patient was treated (unknown treatment type) for the dysuria symptom and was administered medication (unknown type and dose) for the uti.The symptom of urinary discomfort was reported to have resolved 5 days post onset symptom, the dysuria resolved 27 days post onset symptom, and the uti resolved 43 days post onset symptom.The patient symptom of urinary discomfort was assessed to be definite treatment related and possible device related.The patient symptom of dysuria was assessed as probable related to the treatment and unlikely related to the device.The patient symptom of uti was assessed as probable treatment related and probable related to the device.
 
Manufacturer Narrative
Describe event or problem: updated to reflect additional patient symptom of urinary retention.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.
 
Event Description
It was reported that the same day post convective radiofrequency water vapor thermal therapy procedure, the patient experienced urinary discomfort for which medication (unknown type and dose) was administered.Eight days post index procedure, the patient was reported to have experienced dysuria and urinary tract infection (uti).The patient was treated (unknown treatment type) for the dysuria symptom and was administered medication (unknown type and dose) for the uti.At 11 days post procedure, the patient was reported to be experiencing acute urinary retention for which tamsulosin (unknown dose) and catheterization were administer.The symptom of urinary discomfort was reported to have resolved 5 days post onset symptom, the dysuria resolved 27 days post onset symptom, uti resolved 43 days post onset symptom and the urinary retention was reported to have resolved 31 days post onset symptom.The patient symptom of urinary discomfort was assessed to be definite treatment related and possible device related.The patient symptom of dysuria was assessed as probable related to the treatment and unlikely related to the device.The patient symptom of uti was assessed as probable treatment related and probable related to the device.The urinary retention was assessed as definitely related to the procedure and not related to the device.The clinical end point committee assessed the event as probable treatment related and possible related to the device.
 
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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 Key8832264
MDR Text Key152373682
Report Number2937094-2019-60914
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 study,user facility
Type of Report Initial,Followup
Report Date 03/25/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/26/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model NumberD2201
Device Catalogue NumberD2201
Device Lot Number2018020319
Was Device Available for Evaluation? No
Date Manufacturer Received03/12/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other; Required Intervention;
Patient Age64 YR
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