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

Model Number	503-0509
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Headache (1880)
Date of Event	10/26/2016
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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
• Common Device Name: INTERCEPT ORAL SPECIMEN COLLECTION DEVICE
• Manufacturer (Section D): ORASURE TECHNOLOGIES; 220 east first st; bethlehem PA 18015
• MDR Report Key: 6116211
• Report Number: 3004142665-2016-00007
• Device Sequence Number: 893376
• Product Code: PJD
• UDI-Device Identifier: 00608337000078
• UDI-Public: 00608337000078
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K011057
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 11/10/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 02/28/2018
• Device Model Number: 503-0509
• Device Lot Number: 0006651343
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/27/2016
• Initial Report FDA Received Date: 11/21/2016
• 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: Hospitalization