MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2018-11-13 for BIOTENE MOUTHWASH (2013 FORMULATION) manufactured by Kik Custom Products.
[127064417]
Mfr report is associated with argus case (b)(4), biotene mouthwash (2013 formulation).
Patient Sequence No: 1, Text Type: N, H10
[127064418]
Stroke (cerebrovascular accident) [stroke]. Increased level of confusion [confusion]. Disorientation [disorientation]. Speech difficulties [speech disorder]. Case description: this case was reported by a pharmacist via other manufacturer and described the occurrence of stroke in a (b)(6) male patient who received calcium carbonate (tums) unknown for gastrointestinal disorder. Co-suspect products included glycerin (biotene mouthwash (2013 formulation)) mouth wash for product used for unknown indication, dexamethasone tablet for product used for unknown indication, acetylsalicylic acid (aspirin) tablet for product used for unknown indication, cyanocobalamin (vitamin b12) tablet for product used for unknown indication, "pantaprazole" tablet for product used for unknown indication, lenalidomide (revlimid) for multiple myeloma, epoetin alfa for product used for unknown indication, levothyroxine tablet for an unknown indication, fludrocortisone for product used for unknown indication, colesevelam for product used for unknown indication, loperamide + simethicone for diarrhea, psyllium for product used for unknown indication, "colecalciferol" (vitamin d3) tablet for product used for unknown indication, calcium ascorbate (ester c) for product used for unknown indication, desalinated sea water, desalinated sea water, desalinated sea water, desalinated sea water (hydrasense) for product used for unknown indication and clotrimazole + hydrocortisone cream for scrotal swelling. The patient's past medical history included thyroidectomy partial. Concurrent medical conditions included multiple myeloma, dvt, amyloidosis, bladder incontinence, chronic diarrhea, recurrent urinary tract infection, clostridium difficile, orthostatic hypotension, anemia, gastrointestinal disorder, scrotal swelling and confusion. On an unknown date, the patient started tums at an unknown dose and frequency and biotene mouthwash (2013 formulation) (oral) at an unknown dose (see dose text). On (b)(6) 2017, the patient started dexamethasone (oral) 8 mg (see dose text) and aspirin 81 mg once daily (81 mg daily). On an unknown date, the patient started vitamin b12 (oral) 1000 g once daily (1000 g daily). On (b)(6) 2017, the patient started pantaprazole (oral) 40 mg once daily (40 mg daily). On (b)(6) 2017, the patient started revlimid (oral) 10 mg once daily (10 mg daily). On an unknown date, the patient started epoetin alfa 40000 at an unknown frequency, levothyroxine (oral) 112 mcg once daily (112 mcg daily) and fludrocortisone. 1 mg once daily (. 1 mg daily). On (b)(6) 2018, the patient started colesevelam 625 mg once daily (625 mg daily). On an unknown date, the patient started loperamide + simethicone 1 dosage form(s) (see dose text) and psyllium at an unknown dose (see dose text). In (b)(6) 2017, the patient started vitamin d3 1000 iu once daily (1000 iu daily). On an unknown date, the patient started ester c 600 mg once daily (600 mg daily), hydrasense (ocular) at an unknown dose once daily and clotrimazole + hydrocortisone at an unknown dose (see dose text). On (b)(6) 2018, an unknown time after starting tums, biotene mouthwash (2013 formulation) and vitamin b12 and 1 year and 112 days after starting dexamethasone and aspirin, the patient experienced stroke (serious criteria hospitalization, gsk medically significant and life threatening), confusion, disorientation and speech disorder. The action taken with tums was unknown. The action taken with biotene mouthwash (2013 formulation) was unknown. The action taken with dexamethasone was unknown. The action taken with aspirin was unknown. The action taken with vitamin b12 was unknown. The action taken with pantaprazole was unknown. Revlimid was interrupted (dechallenge was negative). Rechallenge with revlimid was unknown. The action taken with epoetin alfa was unknown. The action taken with levothyroxine was unknown. The action taken with fludrocortisone was unknown. The action taken with colesevelam was unknown. The action taken with loperamide + simethicone was unknown. The action taken with psyllium was unknown. The action taken with vitamin d3 was unknown. The action taken with ester c was unknown. The action taken with hydrasense was unknown. The action taken with clotrimazole + hydrocortisone was unknown. On an unknown date, the outcome of the stroke was not recovered/not resolved and the outcome of the confusion, disorientation and speech disorder were not reported. The reporter considered the stroke, confusion, disorientation and speech disorder to be related to tums, biotene mouthwash (2013 formulation), dexamethasone and aspirin. It was unknown if the reporter considered the stroke, confusion, disorientation and speech disorder to be related to vitamin b12. Additional details: the reporter considered the stroke, confusion, disorientation and speech disorder to be related to revlimid. It was the reporter considered the stroke, confusion, disorientation and speech disorder to be related to pantaprazole tablet, epoetin alfa , levothyroxine tablet, fludrocortisone, colesevelam, loperamide + simethicone, psyllium, colecalciferol (vitamin d3) tablet, calcium ascorbate (ester c), hydrasense (sea water), clotrimazole + hydrocortisone cream and midodrine which is he was using as co suspects. There were 18 co-suspect products as per the structured fields. Since the letter was limited to 5 co suspects. Action taken for revlimid and epoetin alfa were temporarily interrupted and action taken for the other suspect medications was not provided (unknown). The reporter assessed the causal relationship suspect medications and stroke as suspected. Initial information was received on (b)(4) 2018. The patient had multiple myeloma. Relevant medical history included lambda light chain amyloidosis, orthostatic hypotension, partial thyroidectomy, anemia. On (b)(6) 2018, the patient was admitted to the hospital with increased level of confusion, speech difficulties. A magnetic resonance imaging reveled a stroke. No infectious cause was found.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9615332-2018-00167 |
| MDR Report Key | 8066544 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2018-11-13 |
| Date of Report | 2018-11-05 |
| Date of Event | 2018-10-16 |
| Date Mfgr Received | 2018-11-05 |
| Date Added to Maude | 2018-11-13 |
| 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 | 2018-11-13 |
| 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. Hospitalization; 2. Life Threatening; 3. Other | 2018-11-13 |