MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-08-12 for ORALBMANDENTALFLOSSSATINFLOSS manufactured by Procter & Gamble Mfg Mexico S De Rl De Cv.
| Report Number | 9710651-2019-00001 |
| MDR Report Key | 8885842 |
| Date Received | 2019-08-12 |
| Date of Report | 2019-07-13 |
| Date of Event | 2018-11-01 |
| Date Mfgr Received | 2019-07-13 |
| Date Added to Maude | 2019-08-12 |
| 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 | MGR. REGULATORY ORAL CARE |
| Manufacturer Street | 8700 MASON-MONTGOMERY RD |
| Manufacturer City | MASON OH 45040 |
| Manufacturer Country | US |
| Manufacturer Postal | 45040 |
| Manufacturer G1 | PROCTER & GAMBLE MFG MEXICO S DE RL DE CV |
| Manufacturer Street | CALLE CUATRO NO. 4 |
| Manufacturer City | NAUCALPAN, 53370 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 53370 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | ORALBMANDENTALFLOSSSATINFLOSS |
| Generic Name | FLOSS, DENTAL |
| Product Code | JES |
| Date Received | 2019-08-12 |
| Lot Number | NOT AVAILABLE |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PROCTER & GAMBLE MFG MEXICO S DE RL DE CV |
| Manufacturer Address | CALLE CUATRO NO. 4 NAUCALPAN, 53370 MX 53370 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-08-12 |