MAUDE Adverse Event Report: ORASURE TECHNOLOGIES INC. ORASURE HIV-1 ORAL SPECIMEN COLLECTION DEVICE

Device Problem Unintended Movement (3026)

Patient Problem Partial thickness (Second Degree) Burn (2694)

Event Date 02/17/2015

Event Type  Injury  

Event Description

An insurance agency swabbed a client with the orasure hiv-1 oral specimen collection device.The next day, the client reported that she developed multiple, painful blisters in her mouth where the pad made contact.

Manufacturer Narrative

The client works for a doctor's office.The doctor from that office saw her and prescribed a medication.

• Brand Name: ORASURE HIV-1 ORAL SPECIMEN COLLECTION DEVICE
• Type of Device: ORASURE HIV-1 ORAL SPECIMEN COLLECTION DEVICE
• Manufacturer (Section D): ORASURE TECHNOLOGIES INC.; 220 east first street; bethlehem PA 18015
• Manufacturer (Section G): ORASURE TECHNOLOGIES INC.; 220 east first street; bethlehem PA 18015
• Manufacturer Contact: jose rosado ; 220 east first street; bethlehem, PA 18015 ; 6108821820
• MDR Report Key: 4623258
• MDR Text Key: 5588934
• Report Number: 3004142665-2015-00001
• Device Sequence Number: 1
• Product Code: MVZ
• Combination Product (y/n): N
• PMA/PMN Number: BP910001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/18/2015

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
• Device Operator: Other
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/18/2015
• Initial Date FDA Received: 03/18/2015
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention