MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-02-08 for LEADER LUMINOMETER R104747-01 manufactured by Hologic Inc..
[66863532]
The customer (b)(6), experienced a reaction when working with bleach while cleaning materials in the lab. Approximately after 2 hours, the operator had red swollen eyes and patches under the eyes. She did not touch her face with her gloves, but did use the collar of her lab coat to wipe her face. There were no immediate actions taken, as the reaction took place after she had left for the day. The operator had been testing since (b)(6) 2016 and had eye swelling occurred on different occasions. She does not use harsh chemicals at home and only recently suspected the reaction is due her work with aptima. The operator did seek medical attention. The doctor has indicated that the fumes could be irritating her eyes, but perhaps rubbing the face with the lab coat could also cause the reaction. The operator is currently not performing aptima testing for the remainder of jan and feb. If the problem persists in march when the operator resumes aptima testing they will contact hologic.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2024800-2017-00005 |
| MDR Report Key | 6312855 |
| Date Received | 2017-02-08 |
| Date of Report | 2017-02-08 |
| Date of Event | 2017-01-12 |
| Date Mfgr Received | 2017-01-12 |
| Date Added to Maude | 2017-02-08 |
| 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 | JULIETTE BUSSE |
| Manufacturer Street | 10210 GENETIC CENTER DRIVE |
| Manufacturer City | SAN DIEGO CA 92121 |
| Manufacturer Country | US |
| Manufacturer Postal | 92121 |
| Manufacturer Phone | 8584108799 |
| 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 | 0 |
| Brand Name | LEADER LUMINOMETER |
| Generic Name | IN-VITRO DIAGNOSTICS |
| Product Code | JJQ |
| Date Received | 2017-02-08 |
| Catalog Number | R104747-01 |
| 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 | 2017-02-08 |