MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-10-01 for TEETHER/TEETHING RING manufactured by Nuby.
[16593292]
My (b)(6) month old son was standing in his exersaucer chewing on his nuby teething ring. I walked into the kitchen and heard an odd noise. I turned around in time to see him gagging with the full teether in his mouth and him sputtering vomit overflowing past the teether onto his exersaucer tray. His eyes watery and bulging, arms flailing with panic in his face going red. I made it to him after a few seconds, pushing my daughter out of the way tripping on the cat and a few toys. I pulled it out of his mouth. Cleared his mouth and nose. He was pretty shaken up as was my daughter after watching it and being moved aside but in a few minutes i was able to settle them both.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5032119 |
| MDR Report Key | 3389581 |
| Date Received | 2013-10-01 |
| Date of Report | 2013-09-30 |
| Date of Event | 2013-09-24 |
| Date Added to Maude | 2013-10-09 |
| 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 |
| 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 | TEETHER/TEETHING RING |
| Generic Name | TEETHER/TEETHING RING |
| Product Code | KKO |
| Date Received | 2013-10-01 |
| Operator | LAY USER/PATIENT |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NUBY |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening; 2. Required No Informationntervention | 2013-10-01 |