MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2018-12-18 for CHILDREN'S MEDICINE DISPENSER 70045CV manufactured by Apothecary Products, Llc.
[130631161]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0002183416-2018-00007 |
| MDR Report Key | 8173435 |
| Report Source | CONSUMER |
| Date Received | 2018-12-18 |
| Date of Report | 2018-12-18 |
| Date of Event | 2018-11-06 |
| Date Mfgr Received | 2018-11-26 |
| Date Added to Maude | 2018-12-18 |
| 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 PAXIA HER |
| Manufacturer Street | 11750 12TH AVE S. |
| Manufacturer City | BURNSVILLE 55337 |
| Manufacturer Country | US |
| Manufacturer Postal | 55337 |
| Manufacturer G1 | APOTHECARY PRODUCTS, LLC |
| Manufacturer Street | 11750 12TH AVE S. |
| Manufacturer City | BURNSVILLE 55337 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 55337 |
| Single Use | 3 |
| Remedial Action | IN |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CHILDREN'S MEDICINE DISPENSER |
| Generic Name | LIQUID ORAL MEDICATION DISPENSER |
| Product Code | KYX |
| Date Received | 2018-12-18 |
| Returned To Mfg | 2018-12-04 |
| Model Number | 70045CV |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | APOTHECARY PRODUCTS, LLC |
| Manufacturer Address | 11750 12TH AVE S. BURNSVILLE, |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2018-12-18 |