MAUDE Adverse Event Report: TRIVIDIA HEALTH INC LANCET-100; LANCET, BLOOD

Model Number LCT, TP NPD 28G 100CT50/CASE LT BL

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

Patient Problem Needle Stick/Puncture (2462)

Event Date 03/31/2022

Event Type  Injury  

Manufacturer Narrative

Internal report reference number: (b)(4).Adverse event report is being submitted due to customer reporting needle stick/puncture.Lancets were not returned for evaluation.Note: manufacturer contacted customer in several follow-up calls to ensure the initial concern is resolved - unable to establish contact with customer at this time.

Event Description

Consumer reported that she had stuck herself with the needle while using the trueplus 28g lancets; lot information was not provided.Customer stated that after using the lancet, she had discarded it in the garbage without the protective cap.Customer stated that while removing the garbage, the uncapped needle had stuck her skin.At the time of the call, the customer felt well and did not report any symptoms.No medical attention associated with the use of the product was reported; customer stated that she had washed her hands.No product complaint was alleged by the customer.Customer stated that it was her mistake in disposing of the lancet without the protective cover.

• Brand Name: LANCET-100
• 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: 14219232
• MDR Text Key: 290164706
• Report Number: 1000113657-2022-00244
• 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: 04/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: LCT, TP NPD 28G 100CT50/CASE LT BL
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 03/31/2022
• Date Manufacturer Received: 03/31/2022
• 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