MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION REZUM; UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Pain (1994)

Event Date 01/10/2022

Event Type  Injury  

Event Description

I had the rezum procedure, but the pain was so intense i had to demand that they stop after 5 seconds.My hands shook for over an hour after that.It was just yesterday so i don't know yet if it's caused permanent harm.Fda safety report id# (b)(4).

• Brand Name: REZUM
• Type of Device: UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION
• MDR Report Key: 13257907
• MDR Text Key: 284003778
• Report Number: MW5106661
• Device Sequence Number: 1
• Product Code: KNS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 01/11/2022

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?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/13/2022
• Patient Sequence Number: 1
• Treatment: LEVOTHYROXINE
• Patient Age: 64 YR
• Patient Sex: Male
• Patient Weight: 78 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White