MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2011-12-01 for BORN FREE GUM BRUSH TEETHER 80527 manufactured by Summer Infant, Inc..
[20414068]
Noticed some of the small "bristles" on baby's blue born free teether were missing. I brushed my hand over it and another one fell out. Baby loves chewing on this teether and has probably ingested missing bristles. I'm not sure whether or not that is safe (b)(4) but i would assume this also could be a choking hazard. This is a link to the product, which appears to have been discontinued: (b)(4). I contacted born free / summer infant who have not addressed the situation. This was the response: thank you for contacting summer infant, i have asked the appropriate manager about this situation and he has confirmed that the product has passed astm child safety tests and is safe for your child. Thank you for your time and patience and have a great day. (b)(4). Born free gum brush teether, blue can be chilled or frozen for children (b)(6) made from (b)(6). Purchase date: (b)(6) 2011. The product was not damaged before the incident. The product was modified before the incident: yes.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5023295 |
| MDR Report Key | 2359417 |
| Date Received | 2011-12-01 |
| Date of Report | 2011-11-14 |
| Date of Event | 2011-11-02 |
| Date Added to Maude | 2011-12-08 |
| 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 | 3 |
| 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 | BORN FREE GUM BRUSH TEETHER |
| Generic Name | TEETHER |
| Product Code | MEF |
| Date Received | 2011-12-01 |
| Catalog Number | 80527 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SUMMER INFANT, INC. |
| Manufacturer Address | 1275 PARK EAST DR WOONSOCKET RI 02895 US 02895 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-12-01 |