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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NXTHERA INC. REZUM DELIVERY DEVICE KIT FOR BPH VAPOR ABLATION SYSTEM

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NXTHERA INC. REZUM DELIVERY DEVICE KIT FOR BPH VAPOR ABLATION SYSTEM Back to Search Results
Model Number D2201-C2
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem No Code Available (3191)
Event Date 11/01/2018
Event Type  Injury  
Event Description
It was reported that approximately 3 months post convective radio frequency water vapor thermal therapy procedure to treat a patient's prostate, the patient had to be scoped due to persistent irritative voiding symptoms. The cystoscope procedure found that there was a noticeable divot in the median lob where the treatment occurred. No further information is available.
 
Manufacturer Narrative
Date of event: the exact event date is unknown. Date received by manufacturer: corrected.
 
Event Description
It was reported that approximately 3 months post convective radio frequency water vapor thermal therapy procedure to treat a patient's prostate, the patient had to be scoped due to persistent irritative voiding symptoms. The cystoscope procedure found that there was a noticeable divot in the median lob where the treatment occurred. No further information is available.
 
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Brand NameREZUM DELIVERY DEVICE KIT FOR BPH
Type of DeviceVAPOR ABLATION SYSTEM
Manufacturer (Section D)
NXTHERA INC.
7351 kirkwood ln n
suite 138
maple grove MN 55369
MDR Report Key8169887
MDR Text Key130519188
Report Number3007795803-2018-00002
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 health professional,user faci
Type of Report Initial,Followup
Report Date 11/27/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/17/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberD2201-C2
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/27/2018
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 12/17/2018 Patient Sequence Number: 1
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