MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2015-01-30 for APTIMA LIQUID PAP TRANSFER TUBES 301154 manufactured by Hologic, Inc..
[5321377]
A patient was in the restroom collecting sample, she accidentally spilled the transport media on the floor and her 2 year old son, who was sitting on the floor touched the media then touched his eyes. The mother flushed the eyes with water and the child was seen by a nurse practitioner. The child appeared to be fine.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2024800-2015-00001 |
| MDR Report Key | 4470615 |
| Report Source | 07 |
| Date Received | 2015-01-30 |
| Date of Report | 2015-01-30 |
| Date of Event | 2015-01-05 |
| Date Added to Maude | 2015-01-30 |
| 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 | 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 LIQUID PAP TRANSFER TUBES |
| Generic Name | TRANSPORT MEDIA TUBES |
| Product Code | LSL |
| Date Received | 2015-01-30 |
| Catalog Number | 301154 |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| 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 | 2015-01-30 |