FDA Adverse Event
Injury
Summary report: N
CHILDREN'S MEDICINE DISPENSER
MDR report key: 8173435
·
Received December 18, 2018
Report
- Report Number
- 0002183416-2018-00007
- Event Type
- Injury
- Date Received
- December 18, 2018
- Date of Event
- November 6, 2018
- Report Date
- December 18, 2018
- Manufacturer
- APOTHECARY PRODUCTS, LLC
- Product Code
- KYX
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
CUSTOMER STATED PRESCRIPTION DRUG WAS ADMINISTERED TO HER (B)(6) INFANT USING THE PRODUCT (MEDI-PALS). THE PRODUCT WAS USED TWICE, WITH NO INCIDENT OCCURRING THE FIRST TIME. THE CUSTOMER STATED THE INFANT STARTED CHOKING AND TURNED PURPLE THE SECOND TIME MEDICINE WAS ADMINISTERED DUE TO THE PRODUCT DIRECTING THE MEDICINE TO THE THROAT INSTEAD OF TO THE SIDE OF THE MOUTH. THE INFANT WENT TO THE ER BY AMBULANCE AND HAD TROUBLE BREATHING. THE INFANT ASPIRATED AGAIN THE NEXT NIGHT AND WAS ADMITTED INTO THE HOSPITAL FOR 2 DAYS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1013697 | CHILDREN'S MEDICINE DISPENSER | LIQUID ORAL MEDICATION DISPENSER | KYX | APOTHECARY PRODUCTS, LLC | 70045CV |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 3 MO | Hospitalization |