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 |