MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2015-02-02 for BIOTENE DRY MOUTH ORAL RINSE (2013 FORMULATION) manufactured by Ultradent Products, Inc./oratech Llc.
[5566816]
Anaphylactic reaction [anaphylactic reaction]. Case description: this case was reported by a consumer and described the occurrence of anaphylactic reaction in a female patient who received oral moisturisers (biotene dry mouth oral rinse (2013 formulation)) mouth wash (batch number 4f26c1, expiry date unknown) for an unknown indication. On an unknown date, the patient started biotene dry mouth oral rinse (2013 formulation). On (b)(6) 2014, an unknown time after starting biotene dry mouth oral rinse (2013 formulation), the patient experienced anaphylactic reaction (serious criteria gsk medically significant). The action taken with biotene dry mouth oral rinse (2013 formulation) was unknown. On an unknown date, the outcome of the anaphylactic reaction was recovered/resolved. The reporter considered the anaphylactic reaction to be related to biotene dry mouth oral rinse (2013 formulation). Additional details: consumer reported she had an anaphylactic reaction on (b)(6) 2014, and believes it was due to the biotene mouth rinse. It was the first and only time she had experienced an anaphylactic reaction. An ae revision was made on (b)(6) 2015, and the revised information is included in the above narrative.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1718912-2015-00007 |
| MDR Report Key | 4478447 |
| Report Source | 04 |
| Date Received | 2015-02-02 |
| Date of Report | 2015-01-01 |
| Date of Event | 2014-12-24 |
| Date Mfgr Received | 2015-01-01 |
| Date Added to Maude | 2015-03-04 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Street | P.O. BOX 13398 |
| Manufacturer City | RESEARCH TRIANGLE PARK NC 27709 |
| Manufacturer Country | US |
| Manufacturer Postal | 27709 |
| Manufacturer Phone | 8888255249 |
| Manufacturer G1 | GSK |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BIOTENE DRY MOUTH ORAL RINSE (2013 FORMULATION) |
| Generic Name | ORAL RINSES |
| Product Code | NTO |
| Date Received | 2015-02-02 |
| Lot Number | 4F26C1 |
| Operator | LAY USER/PATIENT |
| 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 | 2015-02-02 |