MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2016-11-21 for INTERCEPT ORAL SPECIMEN COLLECTION DEVICE 503-0509 manufactured by Orasure Technologies.
[60424105]
A list of ingredients used to treat the intercept collection pad was sent to the customer. The list was reviewed by their employee since she has a sensitivity to preservatives. The employee stated that she avoids preservatives in large concentrations and that there were three suspect ingredients on the list: sodium benzoate, potassium sorbate, and sodium hydroxide. She stated that she does not encounter sodium hydroxide often and believes this ingredient to be the cause of her migraine. Her symptoms were resolved the same day they occurred. Device not returned to manufacturer.
Patient Sequence No: 1, Text Type: N, H10
[60424106]
An unknown female reported that after using the intercept oral fluid collection device she developed an after taste which led to an onset of a migraine headache. She was evaluated by her employer and then transported to the emergency room for evaluation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004142665-2016-00007 |
| MDR Report Key | 6116211 |
| Report Source | USER FACILITY |
| Date Received | 2016-11-21 |
| Date of Report | 2016-11-10 |
| Date of Event | 2016-10-26 |
| Date Mfgr Received | 2016-10-27 |
| Device Manufacturer Date | 2016-03-18 |
| Date Added to Maude | 2016-11-21 |
| 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 ST |
| Manufacturer City | BETHLEHEM PA 18015 |
| Manufacturer Country | US |
| Manufacturer Postal | 18015 |
| Manufacturer Phone | 6108821820 |
| Manufacturer G1 | ORASURE TECHNOLOGIES, INC |
| Manufacturer Street | 220 EAST FIRST ST |
| Manufacturer City | BETHLEHEM PA 18015 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 18015 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | INTERCEPT ORAL SPECIMEN COLLECTION DEVICE |
| Generic Name | INTERCEPT ORAL SPECIMEN COLLECTION DEVICE |
| Product Code | PJD |
| Date Received | 2016-11-21 |
| Model Number | 503-0509 |
| Lot Number | 0006651343 |
| Device Expiration Date | 2018-02-28 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ORASURE TECHNOLOGIES |
| Manufacturer Address | 220 EAST FIRST ST BETHLEHEM PA 18015 US 18015 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2016-11-21 |