MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2019-04-10 for BIOTENE manufactured by Ultradent Products Inc/oratech Llc.
[141449791]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[141449792]
Isn't this the stuff that poisoned people? [poisoning]. This case was reported by a consumer via interactive digital media and described the occurrence of poisoning in a patient who received biotene oralbalance unknown formulation (biotene) unknown (batch number unk, expiry date unknown) for product used for unknown indication. On an unknown date, the patient started biotene. On an unknown date, an unknown time after starting biotene, the patient experienced poisoning (serious criteria gsk medically significant). The action taken with biotene was unknown. On an unknown date, the outcome of the poisoning was unknown. It was unknown if the reporter considered the poisoning to be related to biotene. This additional information: adverse event information received via social media ((b)(6)) on (b)(6) 2019. The consumer posted that, "isn't this the stuff that poisoned people? "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3012293198-2019-00052 |
| MDR Report Key | 8499055 |
| Report Source | CONSUMER |
| Date Received | 2019-04-10 |
| Date of Report | 2019-03-30 |
| Date Mfgr Received | 2019-03-30 |
| Date Added to Maude | 2019-04-10 |
| 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 Street | PO BOX 13398 RESEARCH TRIANGLE PARK |
| Manufacturer City | 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 | 2019-04-10 |
| Lot Number | UNK |
| 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 | 2019-04-10 |