MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-01-04 for BIOTENE MOUTH SPRAY (ORIGINAL) manufactured by Ultradent Products Inc/oratech Llc.
[132214636]
Report # 3012293198-2019-00002 is associated with (b)(4), biotene mouth spray (original).
Patient Sequence No: 1, Text Type: N, H10
[132214637]
They had to give him a shot he went into anaphylactic shock [anaphylactic shock] he couldn't breathe [difficulty breathing]. Case description: this case was reported by a consumer and described the occurrence of anaphylactic shock in a (b)(6) year-old male patient who received glycerin (biotene mouth spray (original)) oromucosal spray (batch number unk, expiry date unknown) for dry mouth. On an unknown date, the patient started biotene mouth spray (original). On an unknown date, an unknown time after starting biotene mouth spray (original), the patient experienced anaphylactic shock (serious criteria hospitalization and gsk medically significant) and difficulty breathing (serious criteria hospitalization). The action taken with biotene mouth spray (original) was unknown. On an unknown date, the outcome of the anaphylactic shock and difficulty breathing were unknown. The reporter considered the anaphylactic shock and difficulty breathing to be related to biotene mouth spray (original). Additional information, adverse event information was received via call on 02 january 2019. The patient's friend called in about biotene mouth spray 1. 5oz (original) and reported that, "he couldn't breathe. They had to give him a shot he went into anaphylactic shock. Emergency medical services came and took him to the hospital because of it. I don't know if he would want the form i will tell him to call you guys back. He is on oxygen in the first place. " this case is link with case id (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3012293198-2019-00002 |
| MDR Report Key | 8218135 |
| Date Received | 2019-01-04 |
| Date of Report | 2019-01-02 |
| Date Mfgr Received | 2019-01-02 |
| Date Added to Maude | 2019-01-04 |
| 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 |
| 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 MOUTH SPRAY (ORIGINAL) |
| Generic Name | ORAL SPRAY |
| Product Code | LFD |
| Date Received | 2019-01-04 |
| Lot Number | UNKNOWN |
| 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. Hospitalization; 2. Other | 2019-01-04 |