MAUDE Adverse Event Report: MEDPLAST MEDICAL, INC. REZUM; UNIT, ELECTROSURGICAL ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)

Model Number D2201

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Urinary Retention (2119)

Event Date 04/01/2020

Event Type  Injury  

Event Description

It was reported that the patient was unhappy with the result of the treatment and not able to void.The patient received a consultancy about the method and its specifics that the treatment works after 2-3 months.

Manufacturer Narrative

Date of event: actual event date is unknown.The product was not returned so no physical analysis could be performed.A review of the device instructions for use (ifu) and operators manual was completed and did not reveal any evidence of device misuse, off-label use, or failure to follow instructions.Urinary retention is documented as a potential complication and risk in ifu.Based on the information available, an evaluation conclusion code of known inherent risk of device was assigned to this investigation.

Event Description

It was reported that the patient was unhappy with the result of the treatment and not able to void.The patient received a consultancy about the method and its specifics that the treatment works after 2-3 months.

• 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 Key: 9965257
• MDR Text Key: 187895158
• Report Number: 2937094-2020-00394
• Device Sequence Number: 1
• Product Code: KNS
• Combination Product (y/n): N
• PMA/PMN Number: K180237
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 05/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/15/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: D2201
• Device Catalogue Number: D2201
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other