MAUDE Adverse Event Report: ORASURE TECHNOLOGIES INTERCEPT ORAL SPECIMEN COLLECTION DEVICE

Model Number 503-0509

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

Patient Problem Headache (1880)

Event Date 10/26/2016

Event Type  Injury  

Manufacturer Narrative

A list of ingredients used to treat the intercept collection pad was sent to the customer.The list was reviewed by their employee since she has a sensitivity to preservatives.The employee stated that she avoids preservatives in large concentrations and that there were three suspect ingredients on the list: sodium benzoate, potassium sorbate, and sodium hydroxide.She stated that she does not encounter sodium hydroxide often and believes this ingredient to be the cause of her migraine.Her symptoms were resolved the same day they occurred.Device not returned to manufacturer.

Event Description

An unknown female reported that after using the intercept oral fluid collection device she developed an after taste which led to an onset of a migraine headache.She was evaluated by her employer and then transported to the emergency room for evaluation.

• Brand Name: INTERCEPT ORAL SPECIMEN COLLECTION DEVICE
• Type of Device: INTERCEPT ORAL SPECIMEN COLLECTION DEVICE
• Manufacturer (Section D): ORASURE TECHNOLOGIES; 220 east first st; bethlehem PA 18015
• Manufacturer (Section G): ORASURE TECHNOLOGIES, INC; 220 east first st; bethlehem PA 18015
• Manufacturer Contact: jose rosado ; 220 east first st; bethlehem, PA 18015 ; 6108821820
• MDR Report Key: 6116211
• MDR Text Key: 60424105
• Report Number: 3004142665-2016-00007
• Device Sequence Number: 1
• Product Code: PJD
• UDI-Device Identifier: 00608337000078
• UDI-Public: 00608337000078
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K011057
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 11/10/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2016
• Is this an Adverse Event Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/28/2018
• Device Model Number: 503-0509
• Device Lot Number: 0006651343
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/27/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/18/2016
• 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): Hospitalization