MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04,05,07 report with the FDA on 2015-03-04 for APTIMA VAGINAL SWAB SPECIMEN COLLECTION KIT 301162 manufactured by Hologic Inc..
[20144534]
A student at the north hollywood public health inadvertently spilled a vial containing aptima specimen transfer kit solution into her left eye. The vial was sterile and did not contain specimen. She experienced burning of the eye after spillage. As directed in the msds, she received medical attention and the eye was irrigated with copious amounts of water with subsequent resolution of symptoms. No further treatment was required.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2024800-2015-00002 |
| MDR Report Key | 4571178 |
| Report Source | 04,05,07 |
| Date Received | 2015-03-04 |
| Date of Report | 2015-03-04 |
| Date of Event | 2015-02-04 |
| Date Mfgr Received | 2015-02-04 |
| Device Manufacturer Date | 2014-10-17 |
| Date Added to Maude | 2015-03-05 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | 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 SPECIMEN COLLECTION KIT |
| Generic Name | IN-VITRO DIAGNOSTIC ASSAY |
| Product Code | LSL |
| Date Received | 2015-03-04 |
| Model Number | 301162 |
| Catalog Number | 301162 |
| Lot Number | 108929 |
| Device Expiration Date | 2015-09-30 |
| Operator | HEALTH PROFESSIONAL |
| 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 | 2015-03-04 |