MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2016-08-03 for APTIMA COMBO 2 ASSAY ON TIGRIS DTS SYSTEM 301130 manufactured by Hologic, Inc..
[51063547]
Environmental health manager reported that five employees had complained about bleach smell. One of the employees had to seek medical attention from a doctor. The employee did not see a doctor due to long wait time. Due to a contamination event hologic fas had cleaned the lab with diluted bleach as per the package insert. Fse manager visited the site and wiped down all three tigris instruments with di water and stated that there was no further bleach smell.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2024800-2016-00020 |
| MDR Report Key | 5843823 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2016-08-03 |
| Date of Report | 2016-08-03 |
| Date of Event | 2016-07-06 |
| Date Mfgr Received | 2016-07-06 |
| Date Added to Maude | 2016-08-03 |
| 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 | 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 COMBO 2 ASSAY ON TIGRIS DTS SYSTEM |
| Generic Name | IN-VITRO DIAGNOSTIC |
| Product Code | LSL |
| Date Received | 2016-08-03 |
| Catalog Number | 301130 |
| 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 | 2016-08-03 |