MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2016-05-20 for APTIMA VAGINAL SWAB COLLECTION KIT 301162 manufactured by Hologic, Inc..
[45611958]
Device not returned to manufacturer.
Patient Sequence No: 1, Text Type: N, H10
[45611959]
Fluid from vaginal collection tube got into laboratory personnel's eye after collecting the patient collected sample. The lab worker flushed their eye with water before visiting doctor. The doctor said there was no dermatitis or iritis observed. The injured person was not wearing proper personal protective equipment at the time of the injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2024800-2016-00017 |
| MDR Report Key | 5669907 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2016-05-20 |
| Date of Report | 2016-05-18 |
| Date of Event | 2016-05-03 |
| Date Mfgr Received | 2016-05-03 |
| Date Added to Maude | 2016-05-20 |
| 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 | MR. RON DOMINGO |
| Manufacturer Street | 10210 GENETIC CENTER DRIVE |
| Manufacturer City | SAN DIEGO CA 92121 |
| Manufacturer Country | US |
| Manufacturer Postal | 92121 |
| Manufacturer Phone | 8584108167 |
| 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 VAGINAL SWAB COLLECTION KIT |
| Generic Name | IN-VITRO DIAGNOSTIC ASSAY |
| Product Code | LSL |
| Date Received | 2016-05-20 |
| Catalog Number | 301162 |
| 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 | 2016-05-20 |