MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-04-28 for APTIMA SPECIMEN TRANSFER KIT 301154 manufactured by Hologic, Inc..
[43999426]
A nurse indicated she may have ingested media from the aptima liquid pap transfer tube (pn: (b)(4)). The nurse had poured the media from the tube and suspects that some may have splashed up onto her hand. After, the nurse opened her coffee mug to drink. Later, the nurse indicated she developed a sore throat. She was unsure if any of the media from the aptima liquid pap transfer tube may have gotten on her hand and into her coffee mug. The aptima liquid pap transfer tube did not contain patient sample. According to the safety data sheet for this product, the media is not considered hazardous.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2024800-2016-00016 |
| MDR Report Key | 5616504 |
| Date Received | 2016-04-28 |
| Date of Report | 2016-04-28 |
| Date of Event | 2016-03-30 |
| Date Mfgr Received | 2016-03-30 |
| Date Added to Maude | 2016-04-28 |
| 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 TRANSFER KIT |
| Generic Name | IN-VITRO DIAGNOSTIC ASSAY |
| Product Code | LSL |
| Date Received | 2016-04-28 |
| Model Number | 301154 |
| Catalog Number | 301154 |
| 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 | 2016-04-28 |