MAUDE Adverse Event Report: ORASURE TECHNOLOGIES INC. INTERCEPT ORAL SPECIMEN COLLECTION DEVICE; NONE

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

Patient Problem Nausea (1970)

Event Date 05/22/2014

Event Type  Injury  

Event Description

A woman swabbed with the intercept oral collection device on (b)(6) 2014.She reported that she has had a bad taste in her mouth and feels sometimes nausea ever since she swabbed with the intercept device.She stated that she feels much better as of (b)(6) 2014 than she felt a few months ago.

• Brand Name: INTERCEPT ORAL SPECIMEN COLLECTION DEVICE
• Type of Device: NONE
• Manufacturer (Section D): ORASURE TECHNOLOGIES INC.; bethlehem PA 18015
• Manufacturer Contact: jose rosado, director ; 220 east first street; bethlehem, PA 18015 ; 6108821820
• MDR Report Key: 4172557
• MDR Text Key: 5101609
• Report Number: 3004142665-2014-00006
• Device Sequence Number: 1
• Product Code: JKA
• Combination Product (y/n): N
• PMA/PMN Number: K011057
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 10/09/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/10/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/11/2014
• 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
• Patient Age: 60 YR