MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-01-25 for BIOTENE manufactured by Ultradent Products Inc/oratech Llc.
[134245074]
Mfr report is associated with argus case (b)(4), biotene.
Patient Sequence No: 1, Text Type: N, H10
[134245075]
Sj? Gren's syndrome [sjogren's syndrome]. Blister [blister]. Burn mouth [burning mouth]. Dry mouth [dry mouth]. Lack of efficacy [device ineffective]. Case description: this case was reported by a consumer via interactive digital media and described the occurrence of sjogren's syndrome in a female patient who received biotene oral balance unknown formulation (biotene) unknown for drug use for unknown indication. On an unknown date, the patient started biotene. On an unknown date, an unknown time after starting biotene, the patient experienced sjogren's syndrome (serious criteria gsk medically significant), blister, burning mouth (serious criteria gsk medically significant), dry mouth and device ineffective. The action taken with biotene was unknown. On an unknown date, the outcome of the sjogren's syndrome, blister, burning mouth and dry mouth were not reported and the outcome of the device ineffective was unknown. It was unknown if the reporter considered the sjogren's syndrome, blister, burning mouth, dry mouth and device ineffective to be related to biotene. This report is made by gsk without prejudice and does not imply any admission or liability for the incident or its consequences. Additional details: the patient got sj? Gren's syndrome with blister, burn mouth, dry mouth. Patient reported that product did not work.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3012293198-2019-00005 |
| MDR Report Key | 8279246 |
| Date Received | 2019-01-25 |
| Date of Report | 2019-01-17 |
| Date Mfgr Received | 2019-01-17 |
| Date Added to Maude | 2019-01-25 |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | BIOTENE |
| Generic Name | UNKNOWN |
| Product Code | LFD |
| Date Received | 2019-01-25 |
| 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 | 2019-01-25 |