MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2016-06-13 for APTIMA UNISEX COLLECTION KIT 301041-01 manufactured by Hologic, Inc..
[47285881]
Solution from aptima unisex collection kit got into the operator's eye. The tube did not contain a patient specimen. The operator washed her eye at the wash station and was taken to the occupational doctor in the hospital. Customer requested a list of chemicals in the aptima unisex collection kit solution, and the list from (b)(4) was provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2024800-2016-00018 |
| MDR Report Key | 5721294 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2016-06-13 |
| Date of Report | 2016-06-13 |
| Date of Event | 2016-05-16 |
| Date Mfgr Received | 2016-05-16 |
| Date Added to Maude | 2016-06-13 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | ANILA TARTE |
| Manufacturer Street | 10210 GENETIC CENTER DRIVE |
| Manufacturer City | SAN DIEGO CA 92121 |
| Manufacturer Country | US |
| Manufacturer Postal | 92121 |
| Manufacturer Phone | 8584108055 |
| Manufacturer G1 | HOLOGIC, INC. |
| Manufacturer Street | 10210 GENETIC CENTER DRIVE |
| Manufacturer City | SAN DIEGO CA 92121 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92121 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | APTIMA UNISEX COLLECTION KIT |
| Generic Name | IN-VITRO DIAGNOSTIC ASSAY |
| Product Code | LSL |
| Date Received | 2016-06-13 |
| Catalog Number | 301041-01 |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HOLOGIC, INC. |
| Manufacturer Address | 10210 GENETIC CENTER DRIVE SAN DIEGO CA 92121 US 92121 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2016-06-13 |