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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 Urinary Retention (2119)
Event Date 01/09/2020
Event Type  Injury  
Event Description
It was reported that, via a social media blog, a patient reported to have undergone a rezum prostate therapy procedure on (b)(6) 2020.The patient stated that the doctor put in a catheter and a urine holding bag; after one week it was taken out, however, the patient still could not urinate on his own.The physician put a catheter back for another week but the urination issue continued.The physician catheterized the patient again, this time for two weeks.The patient reported having seen the physician on (b)(6) 2020.The patient reported that the physician wants to rasp prostate tissue and patient is reluctant to get this done.The patient also reported that he is reverting back to the original problem and is passing a bit of urine in bed at night.
 
Manufacturer Narrative
The product was not returned so no physical analysis could be performed.A review of the 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(s) and controls for complaints related to the clinical event were identified.Based on a thorough review of the reported complaint, the most probable cause for this complaint was considered known inherent risk of device.
 
Event Description
It was reported that, via a social media blog, a patient reported to have undergone a rezum prostate therapy procedure on (b)(6) 2020.The patient stated that the doctor put in a catheter and a urine holding bag; after one week it was taken out, however, the patient still could not urinate on his own.The physician put a catheter back for another week but the urination issue continued.The physician catheterized the patient again, this time for two weeks.The patient reported having seen the physician on 12feb2020.The patient reported that the physician wants to rasp prostate tissue and patient is reluctant to get this done.The patient also reported that he is reverting back to the original problem and is passing a bit of urine in bed at night.
 
Manufacturer Narrative
Evaluation conclusion code: corrected.The product was not returned so no physical analysis could be performed.A review of the 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(s) and controls for complaints related to the clinical event were identified.Based on a thorough review of the reported complaint, the most probable cause for this complaint was considered known inherent risk of device.
 
Event Description
It was reported that, via a social media blog, a patient reported to have undergone a rezum prostate therapy procedure on (b)(6) 2020.The patient stated that the doctor put in a catheter and a urine holding bag; after one week it was taken out, however, the patient still could not urinate on his own.The physician put a catheter back for another week but the urination issue continued.The physician catheterized the patient again, this time for two weeks.The patient reported having seen the physician on (b)(6) 2020.The patient reported that the physician wants to rasp prostate tissue and patient is reluctant to get this done.The patient also reported that he is reverting back to the original problem and is passing a bit of urine in bed at night.
 
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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 Key9821558
MDR Text Key183129457
Report Number2937094-2020-00251
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 company representative,consum
Type of Report Initial,Followup,Followup
Report Date 04/13/2020
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
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 02/11/2020
Initial Date FDA Received03/11/2020
Supplement Dates Manufacturer Received03/25/2020
03/25/2020
Supplement Dates FDA Received04/13/2020
04/13/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other; Required Intervention;
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