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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); Urinary Tract Infection (2120); Dysuria (2684)
Event Date 08/17/2018
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 reported patient symptoms are known risk associated with use of the device.An evaluation conclusion code of known inherent risk of the device was assigned to this investigation.
 
Event Description
It was reported that 8 days post convective radiofrequency water vapor thermal therapy procedure, the patient experienced fever and dysuria.The patient was treated with medication (unknown type and dose) in response to the symptoms.The patient fever was reported to have resolved 12 days post the onset symptom, and the symptom of dysuria resolved 57 days post onset symptom.The patient symptom of dysuria and fever were assessed to be definite treatment related and unlikely related to the device.
 
Manufacturer Narrative
Describe event or problem: updated to reflect additional patient symptom of uti.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 reported patient symptoms are known risk associated with use of the device.An evaluation conclusion code of known inherent risk of the device was assigned to this investigation.
 
Event Description
It was reported that 8 days post convective radiofrequency water vapor thermal therapy procedure, the patient experienced fever and dysuria.The patient was treated with medication (unknown type and dose) due to the symptoms.At 9 days the patient was reported to be experiencing a urinary tract infection (uti).The patient was hospitalized due to the severe uti and treated with piperacillin-tazabactam, iv fluids, and levofloxac (dose unknow).The patient fever resolved 12 days post the onset symptom, the dysuria resolved 57 days post onset symptom and the uti resolved 87 days post onset symptom.The patient symptom of dysuria and fever were assessed to be definite treatment related and unlikely related to the device.The uti was assessed as probable procedure related and not related to the device.The clinical end point committee adjudicated the uti as definitely related to treatment and unlikely related to the device.No further information was provided.
 
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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 Key8824641
MDR Text Key152162526
Report Number2937094-2019-60911
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
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
Initial Date Manufacturer Received 06/27/2019
Initial Date FDA Received07/24/2019
Supplement Dates Manufacturer Received03/12/2020
Supplement Dates FDA Received03/25/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other; Required Intervention;
Patient Age63 YR
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