MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2020-03-02 for A&H SPINBRUSH PRO CLEAN REPLACEMENT HEAD SOFT 2 CT 6687800080 manufactured by Church & Dwight Co., Inc..
| Report Number | 2280705-2020-00008 |
| MDR Report Key | 9773921 |
| Report Source | CONSUMER |
| Date Received | 2020-03-02 |
| Date of Report | 2020-03-02 |
| Date of Event | 2020-01-23 |
| Date Mfgr Received | 2020-01-23 |
| Device Manufacturer Date | 2019-05-29 |
| Date Added to Maude | 2020-03-02 |
| 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 | MRS. STACEY HARSHAW |
| Manufacturer Street | 496 NORTH HARRISON STREET |
| Manufacturer City | PRINCETON, NJ |
| Manufacturer Country | US |
| Manufacturer Phone | 8067868 |
| Manufacturer G1 | HAYCO LTD. |
| Manufacturer Street | 4F CITICORP CENTRE 18 WHITFIELD ROAD |
| Manufacturer City | CAUSEWAY BAY, HONG KONG, |
| Manufacturer Country | CH |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | A&H SPINBRUSH PRO CLEAN REPLACEMENT HEAD SOFT 2 CT |
| Generic Name | POWERED TOOTHBRUSH |
| Product Code | JEQ |
| Date Received | 2020-03-02 |
| Returned To Mfg | 2020-02-07 |
| Model Number | 6687800080 |
| Lot Number | DD9149C |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CHURCH & DWIGHT CO., INC. |
| Manufacturer Address | 500 CHARLES EWING BOULEVARD EWING, NJ US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-02 |