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 017D manufactured by Fridababy.
| Report Number | 3005630901-2019-00011 |
| MDR Report Key | 9603778 |
| Report Source | CONSUMER |
| Date Received | 2020-01-17 |
| Date of Report | 2019-12-11 |
| Date of Event | 2019-11-19 |
| Date Mfgr Received | 2019-11-19 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| 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 | 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 33137 US 33137 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-01-17 |