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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TRIVIDIA HEALTH, INC. SYRINGES BLOOD GLUCOSE SYSTEM

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TRIVIDIA HEALTH, INC. SYRINGES BLOOD GLUCOSE SYSTEM Back to Search Results
Model Number SYRINGES
Device Problem Bent (1059)
Patient Problem No Information (3190)
Event Date 12/06/2017
Event Type  malfunction  
Manufacturer Narrative
(manufacturer narrative
=
t, corrected data
=
f) (b)(4). Product not returned for evaluation. Unable to contact customer to replace product and obtained more information about the complaint. Unable to confirm complaint. Most likely underlying root cause: mlc-28- there was not enough information to determine the mlurc note: on 12/7/2017 manufacturer made a call back to obtain more information about the complaint and unable to make contact with the customer via telephone. Announce myself and customer disconnected the phone. Try several more occasions to contact customer, unable to establish contact. Product notification letter sent to customer to contact customer care.
 
Event Description
Complaint received via email as follow: description summary: the tip of the syringes are jagged and curved like a candy cane so it hurts really bad when you give yourself a shot. Then as you pull the needle back out it pulls the skin and the needle has meaty parts of your body still on the needle. Consumer reported complaint for jagged syringes accompanied by pain during the use of the product. Reporter has emailed on behalf of the customer the customer feels well and did report pain when using the syringe. Medical attention is not reported as a result of the syringes use and reported symptoms. The product storage location is undisclosed. The test strip lot manufacturer's expiration date is undisclosed and open vial date is undisclosed. Limited information provided.
 
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Brand NameSYRINGES
Type of DeviceBLOOD GLUCOSE SYSTEM
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
954677-920
MDR Report Key7161838
MDR Text Key96724433
Report Number1000113657-2018-00009
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
PMA/PMN Number
K993017
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Reporter Occupation
Remedial Action Other
Type of Report Initial
Report Date 01/03/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/03/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberSYRINGES
Device Catalogue NumberN/A
Device Lot NumberN/A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA? No
Event Location Home
Date Manufacturer Received12/06/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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