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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 Problem Hematuria (2558)
Event Date 02/03/2019
Event Type  Injury  
Manufacturer Narrative
Refer to manufacturer report: 2937094-2019-60841 for headache symptom and manufacturer report: 2937094-2019-60844 for discharge of tissue material during urination symptom.
 
Event Description
During procedure, a total of nine treatments were delivered.No adverse event occurred during the procedure.The same day post procedure the patient experienced continuous headache for which ibuprofen (unknown dose) was administered.The patient was discharged post procedure with an indwelling catheter.At 97 days post the index procedure, the patient experienced hematuria, and at 134 days, a single episode of discharge of tissue material during urination.There was no treatment administered for the two reported symptoms.The symptom of intermittent hematuria resolved 11 days post onset symptom, and the symptom of single episode discharge of tissue material during urination resolved the same day post onset symptom.The patient indwelling catheter was removed 183 days post the index procedure.The investigator assessment of the patient headache was assessed as unlikely related to procedure and device.The patient symptom of hematuria and discharge of tissue material during urination were assessed as probable related to procedure and device.The clinical endpoint committee (cec) adjudicated the patient symptom of headache as possible related to the procedure and unlikely related to the device.The patient symptoms of hematuria and discharge of tissue material during urination, per cec, there was no adjudication results required.This report is for hematuria symptom.
 
Manufacturer Narrative
Refer to manufacturer report: 2937094-2019-60841 for headache symptom and manufacturer report: 2937094-2019-60844 for discharge of tissue material during urination symptom.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, an evaluation conclusion code of known inherent risk of the device was assigned to this investigation.
 
Event Description
During procedure, a total of nine treatments were delivered.No adverse event occurred during the procedure.The same day post procedure the patient experienced continuous headache for which ibuprofen (unknown dose) was administered.The patient was discharged post procedure with an indwelling catheter.At 97 days post the index procedure, the patient experienced hematuria, and at 134 days, a single episode of discharge of tissue material during urination.There was no treatment administered for the two reported symptoms.The symptom of intermittent hematuria resolved 11 days post onset symptom, and the symptom of single episode discharge of tissue material during urination resolved the same day post onset symptom.The patient indwelling catheter was removed 183 days post the index procedure.The investigator assessment of the patient headache was assessed as unlikely related to procedure and device.The patient symptom of hematuria and discharge of tissue material during urination were assessed as probable related to procedure and device.The clinical endpoint committee (cec) adjudicated the patient symptom of headache as possible related to the procedure and unlikely related to the device.The patient symptoms of hematuria and discharge of tissue material during urination, per cec, there was no adjudication results required.This report is for hematuria symptom.
 
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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 Key8773951
MDR Text Key156115862
Report Number2937094-2019-60843
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 08/01/2019
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 06/14/2019
Initial Date FDA Received07/09/2019
Supplement Dates Manufacturer Received07/24/2019
Supplement Dates FDA Received08/01/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age55 YR
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