MAUDE Adverse Event Report: TRIVIDIA HEALTH INC LANCE DVC; LANCET, BLOOD

Model Number TRUEDRAW BOXED LANCINGDEVICE

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Pain (1994)

Event Date 12/03/2021

Event Type  Injury  

Manufacturer Narrative

Internal report reference number: (b)(4).Adverse event report is being submitted due to customer reporting pain with use of lancing device.Lancing device was not returned for evaluation.Note: manufacturer contacted customer in follow-up calls on 14-dec-2021 and 21-dec-2021 to ensure the initial concern is resolved - able to establish contact with customer who stated that she had gone to her scheduled doctor's appointment and informed the doctor how the truedraw lancing device caused her pain when she used it.Doctor had prescribed a different brand lancing device for customer.Customer stated that she is no longer using the truedraw lancing device and is now using the brand product prescribed by her doctor.

Event Description

Consumer reported that she experienced pain when using the truedraw lancing device.Customer stated that the lancing device was working as intended, but inquired about a different type of device that would be less painful.Customer was not able to provide product information for the lancing device or the lancets.Customer did not have the lancets at the time of the call, and did not know if they were universal lancets; customer stated that they were freestyle lancets.Customer was advised to adjust the depth dial of the lancing device for less pain.Customer stated that she has an upcoming doctor's appointment and would ask if the doctor recommended changing the lancet gauge.The customer feels well and did not report any symptoms.No medical attention associated with the use of the product was reported.

• Brand Name: LANCE DVC
• Type of Device: LANCET, BLOOD
• Manufacturer (Section D): TRIVIDIA HEALTH INC; 2400 nw 55th court; fort lauderdale FL 33309
• Manufacturer Contact: karen devincent ; 2400 nw 55th court; fort lauderdale, FL 33309
• MDR Report Key: 13109433
• MDR Text Key: 282907050
• Report Number: 1000113657-2021-00805
• Device Sequence Number: 1
• Product Code: FMK
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 12/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: TRUEDRAW BOXED LANCINGDEVICE
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 12/03/2021
• Date Manufacturer Received: 12/03/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other