MAUDE Adverse Event Report: BLINK DEVICE COMPANY TWITCHVIEW; STIMULATOR, NERVE, PERIPHERAL, ELECTRIC

Model Number TVAEA025

Device Problem Unexpected Therapeutic Results (1631)

Patient Problem Skin Tears (2516)

Event Date 07/08/2022

Event Description

Twitchview monitor sticker/adhesive removed skin from patient on removal.Fda safety report id# (b)(4).

• Brand Name: TWITCHVIEW
• Type of Device: STIMULATOR, NERVE, PERIPHERAL, ELECTRIC
• Manufacturer (Section D): BLINK DEVICE COMPANY; seattle WA 98109
• MDR Report Key: 15147820
• MDR Text Key: 297164739
• Report Number: MW5111223
• Device Sequence Number: 1
• Product Code: KOI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: TVAEA025
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/01/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 50 YR
• Patient Sex: Female
• Patient Weight: 51 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White