MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2015-03-18 for ORASURE HIV-1 ORAL SPECIMEN COLLECTION DEVICE manufactured by Orasure Technologies Inc..
[5588934]
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.
Patient Sequence No: 1, Text Type: D, B5
[13084240]
The client works for a doctor's office. The doctor from that office saw her and prescribed a medication.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3004142665-2015-00001 |
| MDR Report Key | 4623258 |
| Report Source | 06 |
| Date Received | 2015-03-18 |
| Date of Report | 2015-03-18 |
| Date of Event | 2015-02-17 |
| Date Mfgr Received | 2015-02-18 |
| Date Added to Maude | 2015-03-24 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MR JOSE ROSADO |
| Manufacturer Street | 220 EAST FIRST STREET |
| Manufacturer City | BETHLEHEM PA 18015 |
| Manufacturer Country | US |
| Manufacturer Postal | 18015 |
| Manufacturer Phone | 6108821820 |
| Manufacturer G1 | ORASURE TECHNOLOGIES INC. |
| Manufacturer Street | 220 EAST FIRST STREET |
| Manufacturer City | BETHLEHEM PA 18015 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 18015 |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ORASURE HIV-1 ORAL SPECIMEN COLLECTION DEVICE |
| Generic Name | ORASURE HIV-1 ORAL SPECIMEN COLLECTION DEVICE |
| Product Code | MVZ |
| Date Received | 2015-03-18 |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ORASURE TECHNOLOGIES INC. |
| Manufacturer Address | 220 EAST FIRST STREET BETHLEHEM PA 18015 US 18015 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2015-03-18 |