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 |