MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-04-06 for APTIMA VAGINAL SWAB SPECIMEN COLLECTION KIT 301162 manufactured by Hologic, Inc..
[42037442]
An incident occurred at (b)(6) where a swab sample was incorrectly placed into the vaginal collection tube. Instead of opening the collection tube and placing the swab inside, the swab was pushed through the penetrable cap. In an attempt to remove the swab, a technician pulled the swab out causing a splash and media got into her eye. The technician was not wearing any safety goggles or safety shield. The technician was taken to the emergency room where her eyes were rinsed thoroughly with water. Upon following up, the technician was taken to the doctor and had her eye examined. She is doing fine, and no issues were found.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2024800-2016-00008 |
| MDR Report Key | 5552786 |
| Date Received | 2016-04-06 |
| Date of Report | 2016-04-06 |
| Date of Event | 2016-03-11 |
| Date Mfgr Received | 2016-03-11 |
| Date Added to Maude | 2016-04-06 |
| 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 | 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 | 0 |
| Brand Name | APTIMA VAGINAL SWAB SPECIMEN COLLECTION KIT |
| Generic Name | IN-VITRO DIAGNOSTIC ASSAY |
| Product Code | LSL |
| Date Received | 2016-04-06 |
| Model Number | 301162 |
| 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 | 2016-04-06 |