MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2011-06-25 for SAFETY 1ST DELUXE HEALTHCARE & GROOMING KIT manufactured by .
[2071421]
When squeezing the bulb on the nasal syringe, the clear piece that goes into the babies nose popped off and hit my baby in the eye and scratching her cheek. I put it back together and tried to squeeze it one more time to only have it happen everytime it was squeezed. Incident date: (b)(6) 2011, this is an estimate. Injury, no first aid or medical attention received. Retailer: (b)(4). Purchase date: (b)(6) 2011, this date is an estimate.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5021183 |
| MDR Report Key | 2147479 |
| Date Received | 2011-06-25 |
| Date of Report | 2011-06-25 |
| Date of Event | 2011-06-22 |
| Date Added to Maude | 2011-07-06 |
| 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 |
| Reporter Occupation | PATIENT FAMILY MEMBER OR FRIEND |
| 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 | SAFETY 1ST DELUXE HEALTHCARE & GROOMING KIT |
| Generic Name | NASAL ASPIRATOR |
| Product Code | KCP |
| Date Received | 2011-06-25 |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-06-25 |