MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2018-08-22 for KIT,APTIMA CMB2 SWAB SPEC COLL 50PK CE 301041-01 manufactured by Hologic, Inc..
[117901182]
Customer, (b)(6), reported an incident where a child ingested an unknown volume of aptima transport media, prior to collection of sample. The swab collection tube contains soln. , transport media (pn: 101768). The child was given plenty of water to drink as treatment. Per the safety data sheet for transport media/collection devices (rev. Date 06/25/2018), the first aid measure for ingestion is to "clean mouth with water and drink afterwards plenty of water. If symptoms persist, call a physician". In addition, the product contains no substances, which at their given concentration, are considered to be hazardous to health. Customer has not called back for any other issues.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2024800-2018-00007 |
| MDR Report Key | 7806222 |
| Report Source | USER FACILITY |
| Date Received | 2018-08-22 |
| Date of Report | 2018-08-22 |
| Date of Event | 2018-07-30 |
| Date Mfgr Received | 2018-07-30 |
| Date Added to Maude | 2018-08-22 |
| 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 | MS JULIETTE BUSSE |
| Manufacturer Street | 10210 GENETIC CENTER DR. |
| Manufacturer City | SAN DIEGO CA 92121 |
| Manufacturer Country | US |
| Manufacturer Postal | 92121 |
| Manufacturer Phone | 8584108799 |
| Manufacturer G1 | HOLOGIC, INC. |
| Manufacturer Street | 10210 GENETIC CENTER DR. |
| 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 | KIT,APTIMA CMB2 SWAB SPEC COLL 50PK CE |
| Generic Name | IN-VITRO DIAGNOSTIC |
| Product Code | LIO |
| Date Received | 2018-08-22 |
| Catalog Number | 301041-01 |
| 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 DR. SAN DIEGO CA 92121 US 92121 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-08-22 |