MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2020-01-17 for FRIDABABY SMILEFRIDA THE TOOTHHUGGER 017B manufactured by Fridababy.
[180247983]
Fda medwatch program report number: mw5091633. Customer reported that their toddler son was chewing his smilefrida the toothhugger toothbrush and that a small piece of metal emerged from within 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
[180247984]
Customer reported that their toddler son was chewing on his smilefrida the toothhugger toothbrush and that a small piece of metal emerged from within the toothbrush head. Fda medwatch program report number: mw5091633.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005630901-2019-00010 |
| MDR Report Key | 9603782 |
| Report Source | CONSUMER |
| Date Received | 2020-01-17 |
| Date of Report | 2019-12-11 |
| Date of Event | 2019-11-12 |
| Date Mfgr Received | 2019-11-12 |
| Date Added to Maude | 2020-01-17 |
| 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 33137 |
| Manufacturer Country | US |
| Manufacturer Postal | 33137 |
| 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 | 2020-01-17 |
| Model Number | 017B |
| 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 33137 US 33137 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-01-17 |