MAUDE Adverse Event Report: ITOVI ITOVI TRACKER / SCANNER; DEVICE GALVANIC SKIN RESPONSE MEASUREMENT

Device Problems Manufacturing, Packaging or Shipping Problem (2975); Material Integrity Problem (2978)

Patient Problem Electric Shock (2554)

Event Type  No Answer Provided  

Event Description

Product recall itovi is recalling the itovi scanner after it recently discovered that this device and its accessories may not have been manufactured according to current good mfg practices, including the 21 cfr 820 quality system regulation.In addition, three complainants have informed the company of alleged electrical shock when using the device.Although we were unable to reproduce the issue, itovi takes these allegations very seriously.

• Brand Name: ITOVI TRACKER / SCANNER
• Type of Device: DEVICE GALVANIC SKIN RESPONSE MEASUREMENT
• Manufacturer (Section D): ITOVI
• MDR Report Key: 7665753
• MDR Text Key: 113514120
• Report Number: MW5078276
• Device Sequence Number: 1
• Product Code: GZO
• 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: 07/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/05/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 06/15/2018
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 58 YR
• Patient Weight: 50