MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2004-01-23 for COLGATE-PALMOLIVE * manufactured by Colgate Palmolive Co.
[367860]
Pt reported they purchased a tube of toothpaste and found labeling discrepancies between a tube they had purchased previously of this latest tube of toothpaste of the same brand. Pt stated the active ingredients and the percentages of active ingredients differed between the two tubes of toothpaste and there were no inactive ingredients listed at all on the recently purchased tube. Additionally, this tube of toothpaste had approx 10 african coutries listed on it. Pt reported the problem to the manufacturer. Mfr told pt the retail store should not have this product on their shelves; it was meant to be sold in the african countries listed in the labeling.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW4003667 |
| MDR Report Key | 512648 |
| Date Received | 2004-01-23 |
| Date of Report | 2003-11-18 |
| Date Added to Maude | 2004-02-25 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COLGATE-PALMOLIVE |
| Generic Name | TOOTHPASTE |
| Product Code | JER |
| Date Received | 2004-01-23 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | NONE |
| ID Number | * |
| Device Availability | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 501657 |
| Manufacturer | COLGATE PALMOLIVE CO |
| Manufacturer Address | 300 PARK AVENUE NEW YORK NY 100227402 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2004-01-23 |