FDA Adverse Event
Injury
Summary report: N
ORASURE HIV-1 ORAL SPECIMEN COLLECTION DEVICE
MDR report key: 4623258
·
Received March 18, 2015
Report
- Report Number
- 3004142665-2015-00001
- Event Type
- Injury
- Date Received
- March 18, 2015
- Date of Event
- February 17, 2015
- Report Date
- March 18, 2015
- Manufacturer
- ORASURE TECHNOLOGIES INC.
- Product Code
- MVZ
- PMA / PMN Number
- BP910001
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE CLIENT WORKS FOR A DOCTOR'S OFFICE. THE DOCTOR FROM THAT OFFICE SAW HER AND PRESCRIBED A MEDICATION.
Description of Event or Problem · 1
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.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 184916 | ORASURE HIV-1 ORAL SPECIMEN COLLECTION DEVICE | ORASURE HIV-1 ORAL SPECIMEN COLLECTION DEVICE | MVZ | ORASURE TECHNOLOGIES INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |