MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,foreign report with the FDA on 2019-03-05 for BIOTENE MOUTHWASH (2013 FORMULATION) manufactured by Kik Custom Products.
[137813837]
The report # 3012293198-2019-00029 is associated with (b)(4), biotene mouthwash (2013 formulation).
Patient Sequence No: 1, Text Type: N, H10
[137813838]
Asthma attack [asthmatic attack]; allergic reaction [allergic reaction]; cough [cough]; few drops may have gone in his windpipe. [tracheal stenosis]. Case description: this case was reported by a consumer via call center representative and described the occurrence of asthmatic attack in a (b)(6) year-old male patient who received glycerin (biotene mouthwash (2013 formulation)) mouth wash (batch number 6l28n1, expiry date 31st october 2018) for dry mouth. On (b)(6) 2019, the patient started biotene mouthwash (2013 formulation) at an unknown dose and frequency. On an unknown date, less than a day after starting biotene mouthwash (2013 formulation), the patient experienced asthmatic attack (serious criteria life threatening), allergic reaction (serious criteria life threatening), cough and tracheal stenosis (serious criteria gsk medically significant). The patient was treated with budesonide + formoterol fumarate (symbicort). The action taken with biotene mouthwash (2013 formulation) was unknown. On an unknown date, the outcome of the asthmatic attack, allergic reaction, cough and tracheal stenosis were unknown. It was unknown if the reporter considered the asthmatic attack, allergic reaction, cough and tracheal stenosis to be related to biotene mouthwash (2013 formulation). Additional details: patient took some biotene mouthwash that was given to him by his dentist as a sample. He then had a asthma attack or an allergic reaction. He said he though that was going to die. Patient said that he gargled with the product and few drops may had gone in his windpipe. Patient's dentist recommended that he uses biotene because he had dry mouth due to the use of symbicort. Patient was taking symbicort every 2 or 3 days. But this morning he had not taken any symbicort. Patient was feeling better now, but still coughing. He said he would go to the hospital if it did not get better soon. He called a pharmacist who told him to take some benadryl.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3012293198-2019-00029 |
| MDR Report Key | 8389940 |
| Report Source | CONSUMER,FOREIGN |
| Date Received | 2019-03-05 |
| Date of Report | 2019-02-22 |
| Date Mfgr Received | 2019-02-22 |
| Date Added to Maude | 2019-03-05 |
| 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 MOUTHWASH (2013 FORMULATION) |
| Generic Name | ORAL RINSES |
| Product Code | LFD |
| Date Received | 2019-03-05 |
| Lot Number | 6L28N1 |
| Device Expiration Date | 2018-10-31 |
| Operator | LAY USER/PATIENT |
| Device Availability | * |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | KIK CUSTOM PRODUCTS |
| Manufacturer Address | ETOBICOKE, ONTARIO CA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening; 2. Other | 2019-03-05 |