MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-04-01 for BIOTENE MOISTURIZING MOUTH SPRAY (2013 FORMULATION) manufactured by Ultradent Products Inc/oratech Llc.
[140815821]
Mfr report is associated with argus case (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[140815822]
Tightness in the patient? S throat [throat tightness], tingling in the patient? S throat [pharyngeal paresthesia], building choking feeling [choking sensation], anaphylactic shock [anaphylactic shock]. Case description: this case was reported by a consumer via call center representative and described the occurrence of throat tightness in a patient who received glycerin (biotene moisturizing mouth spray (2013 formulation)) oromucosal spray for drug use for unknown indication. Concurrent medical conditions included sulfonamide allergy. On an unknown date, the patient started biotene moisturizing mouth spray (2013 formulation). On an unknown date, an unknown time after starting biotene moisturizing mouth spray (2013 formulation), the patient experienced throat tightness, tingling throat and choking sensation. The action taken with biotene moisturizing mouth spray (2013 formulation) was unknown. On an unknown date, the outcome of the throat tightness, tingling throat and choking sensation were unknown. It was unknown if the reporter considered the throat tightness, tingling throat and choking sensation to be related to biotene moisturizing mouth spray (2013 formulation). Additional details: the reporter said it should not be used by anyone with allergy to sulfa drugs. It could downright deadly depending upon sensitivity of patient. The patient reported tightness and tingling in throat, a building choking sensation. The side effect came on third spray of day and started to have serious issue. Follow up information was received on 07 mar 2019: lot code was (batch number u8g131). The patient experienced anaphylactic shock (serious criteria gsk medically significant). The action taken with biotene moisturizing mouth spray (2013 formulation) was unknown. On an unknown date, the outcome of the anaphylactic shock was unknown. It was unknown if the reporter considered the anaphylactic shock to be related to biotene moisturizing mouth spray (2013 formulation). Reason for use dry mouth started. The patient swa health care professional regarding experience. The patient was taken to emergency room for anaphylactic shock.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3012293198-2019-00039 |
| MDR Report Key | 8469241 |
| Date Received | 2019-04-01 |
| Date of Report | 2019-03-06 |
| Date Mfgr Received | 2019-05-23 |
| Date Added to Maude | 2019-04-01 |
| 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 | 0 |
| Brand Name | BIOTENE MOISTURIZING MOUTH SPRAY (2013 FORMULATION) |
| Generic Name | ORAL SPRAY |
| Product Code | LFD |
| Date Received | 2019-04-01 |
| Lot Number | U8G131 |
| Operator | LAY USER/PATIENT |
| Device Availability | * |
| Device Age | DA |
| 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 | 2019-04-01 |