MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2015-10-08 for APTIMA VAGINAL SWAB SPECIMEN COLLECTION KIT 301041-01 manufactured by Hologic Inc..
[27840326]
An event occurred on (b)(6) 2015 at a specimen collection site, where a (b)(6) female child ingested media from the lbld, swab collection tube, combo (pn: lr0233-01), which is part of the aptima combo 2 swab specimen collection kit (pn: 301041-01). The transport tube did not have any patient sample/specimen added. It is unknown how much media was ingested by the child. The incident occurred at a doctor's office and the complaint was called into bio-reference lab (brl) which notified hologic. No direct contact with the doctor's office was made and requests to communicate directly were denied by brl. Brl was told that the immediate actions was to rinse the child's mouth with water. The child cried and said her mouth was burning. Brl stated that the child would be taken to their physician for further assessment. No further information could be obtained from brl. The safety data sheet was provided to brl to provide to the doctor's office. The safety data sheet for transport media/collection devices that the transport media is not considered hazardous. For first aid measures of ingestion, the mouth should be clean with water and drink afterwards plenty of water. If symptoms persist, a physician should be contacted.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2024800-2015-00003 |
| MDR Report Key | 5136096 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2015-10-08 |
| Date of Report | 2015-10-07 |
| Date of Event | 2015-09-10 |
| Date Mfgr Received | 2015-09-10 |
| Date Added to Maude | 2015-10-08 |
| 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 | 3 |
| Brand Name | APTIMA VAGINAL SWAB SPECIMEN COLLECTION KIT |
| Generic Name | IN-VITRO DIAGNOSTIC ASSAY |
| Product Code | LSL |
| Date Received | 2015-10-08 |
| Model Number | 301041-01 |
| Operator | HEALTH PROFESSIONAL |
| 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 | 2015-10-08 |