MAUDE Adverse Event Report: INDIBA INDIBA ACTIV CT9; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number ACTIV CT9

Patient Problems Hypersensitivity/Allergic reaction (1907); Blister (4537)

Event Date 09/27/2023

Event Type  Injury  

Event Description

After use of the indiba activ ct9 machine, this patient developed a small blister at the site.It seems most likely to have been an allergic type reaction.

• Brand Name: INDIBA ACTIV CT9
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): INDIBA
• MDR Report Key: 18093652
• MDR Text Key: 327718968
• Report Number: MW5147904
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: ACTIV CT9
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: INDIBA CREAM
• Patient Outcome(s): Required Intervention
• Patient Age: 24 YR
• Patient Sex: Female