MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2018-08-22 for PANTHER INSTRUMENT 902615 manufactured by Hologic, Inc.
[117897308]
An employee at (b)(6) had bleach from a sample rack bleach bath splash into her eye. This occurred on (b)(6) 2018 when she was placing racks into their bleach bucket for soaking; the employee was not using eye protection when she was performing this activity. She was taken to the emergency room. In the er her eyes were flushed, an acuity test performed and an eye exam performed after staining her eye with a dye. A follow-up eye exam was performed by a specialist on (b)(6) 2018 and no eye damage was noted.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2024800-2018-00006 |
| MDR Report Key | 7806067 |
| Report Source | USER FACILITY |
| Date Received | 2018-08-22 |
| Date of Report | 2018-08-22 |
| Date of Event | 2018-08-07 |
| Date Mfgr Received | 2018-08-07 |
| Date Added to Maude | 2018-08-22 |
| 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 DR |
| Manufacturer City | SAN DIEGO CA 92121 |
| Manufacturer Country | US |
| Manufacturer Postal | 92121 |
| Manufacturer Phone | 8584108799 |
| Manufacturer G1 | HOLOGIC, INC |
| Manufacturer Street | 10210 GENETIC CENTER DR |
| 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 | 2018-08-22 |
| Catalog Number | 902615 |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HOLOGIC, INC |
| Manufacturer Address | 10210 GENETIC CENTER DR SAN DIEGO CA 92121 US 92121 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-08-22 |