MAUDE Adverse Event Report: TRIVIDIA HEALTH INC PEN NEEDLES FG; HYPODERMIC SINGLE LUMEN NEEDLE

Model Number	PNDL, 5BV TVH TP 31G 5MM100CT 30/CS
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Burning Sensation (2146)
Date of Event	04/28/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal report reference number: (b)(4).Pen needles were not returned for evaluation.Most likely underlying root cause: mlc-28: there was not enough information to determine the mlurc.Manufacturer contacted customer in a follow-up call to ensure the replacement products resolved the initial concern - unable to establish contact with customer at this time.
Event or Problem Description
Consumer reported complaint that when she uses the pen needles and attempts to inject her insulin, she gets a burning sensation.Customer did not need medical intervention related to the use of the pen needles.Customer has been using the product for about three months.The package had not been opened or damaged when received by customer.At the time of the call the customer felt well and did not report any symptoms.Customer declined to return any of the pen needles for investigation.

• Brand Name: PEN NEEDLES FG
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): TRIVIDIA HEALTH INC; 2400 nw 55th court; fort lauderdale FL 33309
• MDR Report Key: 10093991
• Report Number: 1000113657-2020-00340
• Device Sequence Number: 777198
• Product Code: FMI
• UDI-Device Identifier: 00021292010775
• UDI-Public: (01)00021292010775
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 05/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 04/30/2023
• Device Model Number: PNDL, 5BV TVH TP 31G 5MM100CT 30/CS
• Device Catalogue Number: S6H01B31-100
• Device Lot Number: 8E618
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 04/28/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/28/2020
• Initial Report FDA Received Date: 05/27/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other