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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 Blood Loss (2597)
Event Date 02/22/2019
Event Type  Injury  
Event Description
It was reported that there was a faulty catheter, and the physician treated the patient's prostate using a delivery device but there was a lot bleeding, and the delivery device needle got stuck during the procedure resulting in more bleeding. The procedure was unable to be completed. The patient was reported to be fine and stable.
 
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Brand NameREZUM
Type of DeviceUNIT, ELECTROSURGICAL ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)
Manufacturer (Section D)
MEDPLAST MEDICAL, INC.
5079 33rd street se
grand rapids MI 49512
Manufacturer (Section G)
MEDPLAST MEDICAL, INC.
5079 33rd street se
grand rapids MI 49512
Manufacturer Contact
alyson harris
150 baytech drive
san jose, CA 95134
4089353452
MDR Report Key8445157
MDR Text Key139602840
Report Number2937094-2019-60363
Device Sequence Number1
Product Code KNS
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K180237
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 07/12/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/22/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/31/2019
Device Model NumberD2201
Device Catalogue NumberD2201
Device Lot Number2018071181
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/13/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/23/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 03/22/2019 Patient Sequence Number: 1
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