MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-05-05 for BABIES R US NASAL ASPIRATOR manufactured by Babies R Us.
[5789698]
Babies r us branded nasal aspirator sold at babies r us is ineffective and or defective. The product was not damaged before the incident. The product was not modified before the incident. Left feedback on website and will pursue additional contact methods. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5042574 |
| MDR Report Key | 4759008 |
| Date Received | 2015-05-05 |
| Date of Report | 2015-04-20 |
| Date of Event | 2015-04-20 |
| Date Added to Maude | 2015-05-11 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BABIES R US NASAL ASPIRATOR |
| Generic Name | NASAL ASPIRATOR |
| Product Code | LRQ |
| Date Received | 2015-05-05 |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BABIES R US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-05-05 |