MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2020-02-11 for FRIDABABY SMILEFRIDA THE TOOTHHUGGER 017D manufactured by Fridababy.
[183864739]
Customer reported that they gave their (b)(6) year old daughter her smilefrida the toothhugger toothbrush to brush her own teeth. Customer then reported that her daughter likes to chew on toothbrushes and customer allowed her daughter to chew on the toothhugger. Customer reported that her daughter took the toothhugger out of her mouth after chewing on it and a small metal piece was exposed from the inside of the toothbrush head. The child, while under supervision, was allowed to chew on the product even though the labeling clearly states the product is not a teether and should not be chewed or bitten. Chewing through the rubber tpe over-mold and pp plastic, thereby exposing a small metal piece which could be a potential choking hazard to children.
Patient Sequence No: 1, Text Type: N, H10
[183864740]
Customer reported that their (b)(6) year old daughter was brushing her teeth with her smilefrida the toothhugger toothbrush. Customer reported that her daughter likes to chew on the toothbrush, and while chewing on it a piece of metal was exposed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005630901-2020-00015 |
| MDR Report Key | 9694349 |
| Report Source | CONSUMER |
| Date Received | 2020-02-11 |
| Date of Report | 2020-02-06 |
| Date of Event | 2020-02-05 |
| Date Mfgr Received | 2020-02-05 |
| Date Added to Maude | 2020-02-11 |
| 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 | NICOLE GREENE |
| Manufacturer Street | 82 NE 26TH STREET SUITE 102 |
| Manufacturer City | MIAMI, |
| Manufacturer Country | US |
| Manufacturer G1 | JIANGSU PROVINCE YANGZHOU SHUGUANG TOOTHBRUSH MANU |
| Manufacturer Street | NO. 1, CHENG XI ROAD HANGJI TOWN |
| Manufacturer City | YANGZHOU, 225111 |
| Manufacturer Country | CH |
| Manufacturer Postal Code | 225111 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FRIDABABY SMILEFRIDA THE TOOTHHUGGER |
| Generic Name | TOOTHBRUSH |
| Product Code | EFW |
| Date Received | 2020-02-11 |
| Model Number | 017D |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | FRIDABABY |
| Manufacturer Address | 82 NE 26TH STREET SUITE 102 MIAMI, FL US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-11 |