MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-12-15 for APTIMA SPECIMEN COLLECTION KIT 301041-01 manufactured by Hologic Incorporated.
[33593531]
An incident at (b)(4) ob-gyn occurred while a nurse was collecting sample for the aptima combo 2 swab specimen collection kit (pn: 301041-01). The nurse was holding an open swab collection tube for the doctor. The tube was hit with her hand which ejected material from the tube and into her eye. The aptima tube did not contain any patient sample. The nurse immediately flushed her eyes with water. It was noted that her eye was red and irritated after it was flushed. A copy of the safety data sheet was provided via the hologic website. The nurse was seen by an eye doctor who applied antibiotic ointment and put an eye patch on the nurse for 24 hours. Upon following up with the customer, she has indicated that her eye has cleared up and there are no visual indication of injury that remains.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2024800-2015-00006 |
| MDR Report Key | 5299566 |
| Date Received | 2015-12-15 |
| Date of Report | 2015-12-15 |
| Date of Event | 2015-11-17 |
| Date Mfgr Received | 2015-11-17 |
| Date Added to Maude | 2015-12-15 |
| 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 SPECIMEN COLLECTION KIT |
| Generic Name | IN-VITRO DIAGNOSTIC ASSAY |
| Product Code | LSL |
| Date Received | 2015-12-15 |
| Catalog Number | 301041-01 |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HOLOGIC INCORPORATED |
| Manufacturer Address | 10210 GENETIC CENTER DRIVE SAN DIEGO CA 92121 US 92121 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2015-12-15 |