MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-09-06 for KIT, APTIMA CMB2 ASSAY LR0167G-01 manufactured by Hologic, Inc..
[85087347]
(b)(6) reported that one of their operators ((b)(6)) had splashed auto detect 1 (from bottle a / pn: lr0167g-01) into her eyes while she was removing the quick disconnect fitting from the auto detect 1a (ad1a) bottle of the tigris. The operator was wearing a face shield when incident happened but was crouching close to the fluid drawer such that the splash went underneath the face shield. The operator immediately rinsed her eyes for 15 minutes. The operator felt irritation in her eyes and went to see a physician. The physician treated her and she was given two days off. The operator went to see a physician but was able to return to work after two days.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2024800-2017-00020 |
| MDR Report Key | 6847142 |
| Date Received | 2017-09-06 |
| Date of Report | 2017-09-06 |
| Date of Event | 2017-08-08 |
| Date Facility Aware | 2017-08-08 |
| Date Mfgr Received | 2017-08-08 |
| Date Added to Maude | 2017-09-06 |
| 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 | 0 |
| Brand Name | KIT, APTIMA CMB2 ASSAY |
| Generic Name | IN-VITRO DIAGNOSTIC |
| Product Code | LSL |
| Date Received | 2017-09-06 |
| Catalog Number | LR0167G-01 |
| 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 | 2017-09-06 |