MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2017-06-06 for KIT,APTIMA CMB2 SWAB SPEC COLL 50PK CE 301041-01 manufactured by Hologic, Inc..
[76774207]
(b)(6) (customer) called hologic technical support to find out what is in the aptima transport media for the unisex swab collection kit. She described that a child was in the office with the mother. The child grabbed the collection device while it was being prepared for collection and likely ingested a small amount of the liquid. Hologic ts directed mary to the safety data sheet on hologic website. Which stated under first aid measures: ingestion- clean mouth with water and drink afterwards plenty of water. If symptoms persist, call a physician. Mary printed the safety data sheet for the child's mother who was not concerned as the child likely did not ingest much liquid and according to the sds, the material was not hazardous. No forms were submitted for the incident by the patient's mother. Per sds, child's mouth was rinsed with water and child was given water to drink. Customer has not called with any additional questions or to voice any additional concerns.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2024800-2017-00017 |
| MDR Report Key | 6615149 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2017-06-06 |
| Date of Report | 2017-06-06 |
| Date of Event | 2017-05-09 |
| Date Mfgr Received | 2017-05-09 |
| Date Added to Maude | 2017-06-06 |
| 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 | LSL |
| Date Received | 2017-06-06 |
| Catalog Number | 301041-01 |
| Lot Number | N/A |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| 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 | 2017-06-06 |