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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 Micturition Urgency (1871); Unspecified Infection (1930); Urinary Tract Infection (2120)
Event Date 05/03/2019
Event Type  Injury  
Manufacturer Narrative
Date of event: the exact date of the event was not reported.
 
Event Description
It was reported that post a convective radiofrequency water vapor thermal therapy procedure the patient was experiencing a urinary tract infection and presented to the surgeon with a scrotal infection.The surgeon drained the hydrocele infection and washed the scrotal sac and closed.The patient was prescribed an extended course of antibiotics.Patient has good emptying of the bladder with some intermittent urgency.
 
Manufacturer Narrative
Date of event the exact date of the event was not reported the device history record (dhr) confirmed that the devices met all material, assembly and performance specifications.The device was not returned so physical analysis could not be performed.A review of the instructions for use and operators manual did not reveal any evidence of device misuse, off-label use or failure to follow instructions.The adverse events reported are potential complications that may occur and therefore, the cause code of known inherent risk of device was applied to this event.
 
Event Description
It was reported that post a convective radiofrequency water vapor thermal therapy procedure the patient was experiencing a urinary tract infection and presented to the surgeon with a scrotal infection.The surgeon drained the hydrocele infection and washed the scrotal sac and closed.The patient was prescribed an extended course of antibiotics.Patient has good emptying of the bladder with some intermittent urgency.
 
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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 Key8936720
MDR Text Key155783162
Report Number2937094-2019-61071
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 foreign,health professional,u
Type of Report Initial,Followup
Report Date 09/26/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/27/2019
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 Received09/24/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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