MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2017-11-29 for PANTHER INSTRUMENT 902615 manufactured by Hologic Incorporated.
[93229662]
(b)(6) (customer) reported that one of their operators ((b)(6)) had splashed bleach into one of her eyes on. It happened when the operator was making bleach solution to clean panther work surface areas. The operator was not wearing any eye protective glasses or goggles. The operator washed her eye with water and then went to seek medical attention. The bleach had burned the outer layer of her affected eye and her vision has been blurry. The doctor has instructed the operator to wear goggles until the eye has healed and was given medical leave.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2024800-2017-00027 |
| MDR Report Key | 7067728 |
| Report Source | USER FACILITY |
| Date Received | 2017-11-29 |
| Date of Report | 2017-11-26 |
| Date of Event | 2017-11-07 |
| Date Mfgr Received | 2017-11-07 |
| Date Added to Maude | 2017-11-29 |
| 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 | MS. 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 | 3 |
| Brand Name | PANTHER INSTRUMENT |
| Generic Name | IN-VITRO DIAGNOSTICS |
| Product Code | LSL |
| Date Received | 2017-11-29 |
| Catalog Number | 902615 |
| 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. Other | 2017-11-29 |