MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-03-14 for BIOTENE ORAL BALANCE GEL (AROMA) manufactured by Ultradent Products Inc/oratech Llc.
[138970940]
(b)(4). Report # 3012293198-2019-00020 is associated with (b)(4), biotene oral balance gel (aroma). (previously 1718912-2017-00022) device evaluation ((b)(4)) completed 25 july 2017, product not returned from customer for tube issue
Patient Sequence No: 1, Text Type: N, H10
[138970941]
I just came out of the hospital [hospitalization]. I have cataracts in one eye [cataract]. The other eye is shifting now [eye disorder]. I am not feeling good [feeling abnormal]. The product is biotene oral balance gel 1. 5oz (aroma). A 1. 5 oz. Tube only lasted for two days [product complaint]. Case description: this case was reported by a consumer and described the occurrence of cataract in a (b)(6)-year-old female patient who received glycerin (biotene mouth spray (savannah)) oromucosal spray (batch number unk, expiry date unknown) for dry mouth. This case was associated with a product complaint. Co-suspect products included glycerin (biotene oral balance gel (aroma)) gel (batch number unk, expiry date unknown) for dry mouth and sodium fluoride (biotene toothpaste variant not specified (savannah)) toothpaste (batch number unk, expiry date unknown) for dental cleaning. On an unknown date, the patient started biotene mouth spray (savannah), biotene oral balance gel (aroma) and biotene toothpaste variant not specified (savannah) at an unknown dose and frequency. On an unknown date, an unknown time after starting biotene mouth spray (savannah), biotene oral balance gel (aroma) and biotene toothpaste variant not specified (savannah), the patient experienced cataract, eye disorder and product complaint. Biotene mouth spray (savannah) was discontinued (dechallenge was negative). Biotene oral balance gel (aroma) was continued with no change. Biotene toothpaste variant not specified (savannah) was continued with no change. On an unknown date, the outcome of the cataract and eye disorder were not recovered/not resolved and the outcome of the product complaint was unknown. It was unknown if the reporter considered the cataract and eye disorder to be related to biotene mouth spray (savannah), biotene oral balance gel (aroma) and biotene toothpaste variant not specified (savannah). Additional details, the adverse event information was received on 27 june 2017. Consumer reported that, "the product is biotene oral balance gel 1. 5oz (aroma). A 1. 5 oz. Tube only lasted for two days. It usually lasts for two weeks. I use the product two to four times per day. I love this. The product practically saved my life. I have used the product for many, many years. It helps me. It gives me moisture, and i can talk and swallow. There is nothing else like it. I also use the toothpaste. I used to use the spray. I have cataracts in one eye. The other eye is shifting now. I will be seeing the doctor for that. " follow up information was received on 13 july 2017. Consumer used biotene oral balance gel 1. 5oz (aroma) and biotene toothpaste savannah. She stated that she used to use the biotene mouth spray. Consumer stated, "i am not feeling good. I just came out of the hospital. " consumer was (b)(6) years old. She stated that she used biotene oral balance gel 1. 5oz (aroma) two to four times per day. The hospitalization and feeling abnormal event were added to case. Event outcome for hospitalization and feeling abnormal was unknown. The causality for hospitalization and feeling abnormal was unknown. It was unknown if the reporter considered hospitalization and feeling abnormal to be related to biotene mouth spray (savannah), biotene oral balance gel (aroma) and biotene toothpaste variant not specified (savannah). Follow up information was received on 25 july 2017. From quality assurance (qa) department regarding complaint number (b)(4) (issue number) for lot number unknown. The investigation report included that, the product sample was not received. Without the returned product or a valid lot number no investigation can take place. Concern will be re opened and evaluated if the complaint sample was received. This was a low risk, level 1 complaint. Concern can be closed. Expiration date for biotene oral balance gel (aroma) was updated in the case as 31 august 2019.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3012293198-2019-00020 |
| MDR Report Key | 8420117 |
| Date Received | 2019-03-14 |
| Date of Report | 2017-06-27 |
| Date Mfgr Received | 2017-07-25 |
| Date Added to Maude | 2019-03-14 |
| 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 ORAL BALANCE GEL (AROMA) |
| Generic Name | ORAL GEL |
| Product Code | LFD |
| Date Received | 2019-03-14 |
| Lot Number | UNK |
| Operator | LAY USER/PATIENT |
| Device Availability | * |
| Device Eval'ed by Mfgr | N |
| 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 | 2019-03-14 |