MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2019-03-05 for INTERCEPT 503-0509 manufactured by Orasure Technologies Inc.
[137865960]
It was reported on (b)() 2019 to orasure technologies, inc. That a customer had an allergic reaction to our intercept oral drug screen test. The employee was currently in the er with a swollen throat/tongue. The customer was provided the safety statement for the intercept oral swab device to determine if a component may caused the allergic reaction in the customer. The customer returned to work on (b)() 2019 but reported to still be shaking and swollen. The customer was still having symptoms as of (b)() 2019 and had made an appointment with a specialist for allergy testing to be completed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004142665-2019-00002 |
| MDR Report Key | 8391484 |
| Report Source | USER FACILITY |
| Date Received | 2019-03-05 |
| Date Facility Aware | 2019-02-13 |
| Date Mfgr Received | 2019-02-13 |
| Date Added to Maude | 2019-03-05 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| 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 | 3 |
| Remedial Action | NO |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | INTERCEPT |
| Generic Name | INTERCEPT ORAL FLUID DRUG TEST |
| Product Code | PJD |
| Date Received | 2019-03-05 |
| Model Number | 503-0509 |
| Lot Number | 0006667361 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| 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. Hospitalization | 2019-03-05 |