MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,foreign report with the FDA on 2019-01-03 for BIOTENE manufactured by Ultradent Products Inc/oratech Llc.
[131968246]
Mdr 3012293198-2019-00001 is associated with argus case (b)(4), biotene (biotene oral balance unknown formulation).
Patient Sequence No: 1, Text Type: N, H10
[131968247]
Tumour on my gum which turned out to be cancer (gingival cancer). My saliva glands were burnt beyond ever returning (salivary gland disorder). Afraid it just made my mouth worse (condition aggravated). Case description: this case was reported by a consumer via (b)(6) interactive digital media and described the occurrence of gingival cancer in a female patient who received biotene oral balance unknown formulation (biotene) unknown for gingival disorder. On an unknown date, the patient started biotene at an unknown dose and frequency. On an unknown date, an unknown time after starting biotene, the patient experienced gingival cancer (serious criteria gsk medically significant), salivary gland disorder, condition aggravated and intentional use for unlabeled indication. The action taken with biotene was unknown. On an unknown date, the outcome of the gingival cancer, salivary gland disorder and condition aggravated were not reported and the outcome of the intentional use for unlabeled indication was unknown. It was unknown if the reporter considered the gingival cancer and salivary gland disorder to be related to biotene. The reporter considered the condition aggravated to be related to biotene. Additional details: patient had it for a tumour on her gum witch turned out to be cancer but her saliva glands were burnt beyond ever returning she put some biotene on last night from reported day and she afraid it just made her mouth worse after 16 years and the saliva spray she had used she would just settle for that.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3012293198-2019-00001 |
| MDR Report Key | 8213577 |
| Report Source | CONSUMER,FOREIGN |
| Date Received | 2019-01-03 |
| Date of Report | 2018-12-24 |
| Date Mfgr Received | 2018-12-24 |
| Date Added to Maude | 2019-01-03 |
| 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 Street | PO BOX 13398 |
| Manufacturer City | RESEARCH TRIANGLE PARK NC 27709 |
| Manufacturer Country | US |
| Manufacturer Postal | 27709 |
| Manufacturer Phone | 8888255249 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BIOTENE |
| Generic Name | UNKNOWN |
| Product Code | LFD |
| Date Received | 2019-01-03 |
| Operator | LAY USER/PATIENT |
| Device Availability | * |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ULTRADENT PRODUCTS INC/ORATECH LLC |
| Manufacturer Address | SOUTH JORDAN UT US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-01-03 |