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 Problems Bacterial Infection (1735); Fever (1858); Unspecified Infection (1930); Chills (2191)

Event Date 05/24/2020

Event Type  Injury  

Manufacturer Narrative

The exact date of the event was not reported.

Event Description

It was reported through social media a patient had a negative experience after receiving water vapor thermal therapy procedure.The patient presented with e.Coli infection that went into the bloodstream (septicemia) and encountered raging fever and chills.The patient was taken to the emergency room (er) and was admitted for a round of several iv antibiotics to clear up the e.Coli infection which resulted in the patient experiencing c-diff infection which was reported to be difficult to clear up.The patient did recover from both the e-coli infection and subsequent c-diff infection, but it took multiple iv antibiotics to clear up a very resistant e-coli infection in the blood.Allegedly, the patient continues to have urinary issues post water vapor thermal therapy procedure.There is no report of product malfunction or procedure allegation.

Event Description

It was reported through social media a patient had a negative experience after receiving water vapor thermal therapy procedure.The patient presented with e.Coli infection that went into the bloodstream (septicemia) and encountered raging fever and chills.The patient was taken to the emergency room (er) and was admitted for a round of several iv antibiotics to clear up the e.Coli infection which resulted in the patient experiencing c-diff infection which was reported to be difficult to clear up.The patient did recover from both the e-coli infection and subsequent c-diff infection, but it took multiple iv antibiotics to clear up a very resistant e-coli infection in the blood.Allegedly, the patient continues to have urinary issues post water vapor thermal therapy procedure.There is no report of product malfunction or procedure allegation.

Manufacturer Narrative

Date of event the exact date of the event was not reported the device is not available for analysis.A review of the rezum 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 review of the information available, patient symptoms of infection and septicemia are known risks associated with the use of the device and is noted as such in the instruction for use (ifu).An evaluation conclusion code of known inherent risk of the device was assigned to this investigation.

• 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: 10159351
• MDR Text Key: 195299420
• Report Number: 2937094-2020-00480
• 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: consumer
• Type of Report: Initial,Followup
• Report Date: 07/22/2020

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 Number: D2201
• Device Catalogue Number: D2201
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/24/2020
• Initial Date FDA Received: 06/16/2020
• Supplement Dates Manufacturer Received: 06/25/2020
• Supplement Dates FDA Received: 07/22/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other