MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-02-11 for APTIMA HPV-GT 303236 manufactured by Hologic Incorporated.
[38084933]
An incident occurred at (b)(6) when a customer had a small amount of (b)(6) enzyme splash into his eye as the reagent was being discarded after use. The operator was wearing prescription glasses at the time of the incident, but a splatter got under his glasses and into his eye. No reagent splashed onto the customer's skin. The customer immediately rinsed their eyes with plenty of water. The operator's indicated there was a little sting, but his eyes were not watering. When following up with the customer, he did not seek medical attention and his eyes are feeling fine.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2024800-2016-00001 |
| MDR Report Key | 5432124 |
| Date Received | 2016-02-11 |
| Date of Report | 2016-02-11 |
| Date of Event | 2016-01-15 |
| Date Mfgr Received | 2016-01-15 |
| Date Added to Maude | 2016-02-11 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. RON DOMINGO |
| Manufacturer Street | 10210 GENETIC CENTER DRIVE |
| Manufacturer City | SAN DIEGO CA 92129 |
| Manufacturer Country | US |
| Manufacturer Postal | 92129 |
| Manufacturer Phone | 8584108167 |
| Manufacturer G1 | HOLOGIC INC. |
| Manufacturer Street | 10210 GENETIC CENTER DRIVE |
| Manufacturer City | SAN DIEGO CA 92129 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92129 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | APTIMA HPV-GT |
| Generic Name | IN-VITRO DIAGNOSTIC ASSAY |
| Product Code | OYB |
| Date Received | 2016-02-11 |
| Catalog Number | 303236 |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HOLOGIC INCORPORATED |
| Manufacturer Address | 10210 GENETIC CENTER DRIVE SAN DIEGO CA 92121 US 92121 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2016-02-11 |