MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,01,04 report with the FDA on 2013-10-21 for COLGATE SENSITIVE PRO-RELIEF DAILY USE PASTE manufactured by Colgae Palmolive Industrial Ltda..
[3792792]
Initial info was received on (b)(6) 2013 from a consumer. A (b)(6) year old male consumer used colgate sensitive pro-relief daily use paste toothpaste and developed tooth erosion and mouth swelling. He began using the toothpaste three times a day, four months prior to this report on an unspecified date in (b)(6) 2013 (dosage unk). Subsequently, on an unspecified date in 2013, he experienced the events. The toothpaste was discontinued on an unspecified date in 2013 and then reintroduced on an unk date in 2013 and the consumer experienced the same events. A dentist was consulted and recommended he stop using the toothpaste as "his teeth didn't adapt with the product". Treatment included diclofenac, paracetamol, lidocaine and cephalexin as well as a recommended tooth extraction. At the time of this report, the consumer had discontinued the toothpaste on an unspecified date in 2013 and the events were ongoing. This case is referenced as (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1000117969-2013-00011 |
| MDR Report Key | 3429936 |
| Report Source | 00,01,04 |
| Date Received | 2013-10-21 |
| Date of Report | 2013-09-29 |
| Date of Event | 2013-01-01 |
| Date Mfgr Received | 2013-09-29 |
| Date Added to Maude | 2013-10-28 |
| 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 | 0 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | DONALDSON DANTAS |
| Manufacturer Street | VIA ANCHIETA, KM 14 |
| Manufacturer City | SAN BERNARDO DO COMPO, SP 09696-000 |
| Manufacturer Country | BR |
| Manufacturer Postal | 09696-000 |
| Manufacturer Phone | 143666837 |
| Manufacturer G1 | COLGAGTE PALMOLIVE INDUSTRIAL LTDA. |
| Manufacturer Street | VIA ANCHIETA, KM 14 |
| Manufacturer City | SAN BERNARDO DO CAMPO, SP 09696-00 |
| Manufacturer Country | BR |
| Manufacturer Postal Code | 09696-000 |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COLGATE SENSITIVE PRO-RELIEF DAILY USE PASTE |
| Generic Name | TOTHPASTE |
| Product Code | JER |
| Date Received | 2013-10-21 |
| Operator | LAY USER/PATIENT |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COLGAE PALMOLIVE INDUSTRIAL LTDA. |
| Manufacturer Address | VIA ANCHIETA, KM 14 SAO BERNARDO DO COMPO, SP 09696-00 BR 09696-000 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2013-10-21 |