MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-10-01 for NIX ULTRA LICE TREATMENT KIT manufactured by Prestige Brands Inc..
[122299943]
This serious case reported to company refers to a (b)(6) female with a medical history of high blood pressure, treated with metoprolol 25mg once per day. On (b)(6) 2018, a consumer used nix ultra liquid to treat head lice and experienced headache, nausea and increase in blood pressure. Consumer applied product to hair over a sink and the product accidentally "went up her nose": she instantly got a "pounding" headache and was taken for medical evaluation. Blood pressure was reported to be elevated upon arrival to clinic. Exact bp not known. Consumer was treated with clonidine 0. 1mg x2 with no effect on lowering her bp. Consumer was then taken to the emergency department by her son and upon arrival her bp 205/94. She was treated with "iv benadryl and promethazine" then released home. On (b)(6) 2018, consumer returned to emergency department with "pounding headache, high bp and nausea". Ct of the head was negative. Bp 199/99. Consumer was treated with "sodium chloride, diphenhydramine 50mg, dexamethasone 10mg, ketorolac 30mg, and metoclopramide 5mg". It was reported that bp stabilized at 156/77, headache subsided and consumer released home with an increased strength of metoprolol.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3011801804-2018-00002 |
| MDR Report Key | 7922471 |
| Date Received | 2018-10-01 |
| Date of Report | 2018-08-13 |
| Date of Event | 2018-07-15 |
| Date Mfgr Received | 2018-07-17 |
| Date Added to Maude | 2018-10-01 |
| 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 Contact | PRESTIGE BRANDS PV & SAFETY |
| Manufacturer Street | 4615 MURRAY PLACE |
| Manufacturer City | LYNCHBURG VA 24502 |
| Manufacturer Country | US |
| Manufacturer Postal | 24502 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | NIX ULTRA LICE TREATMENT KIT |
| Generic Name | LICE REMOVAL KIT |
| Product Code | LJL |
| Date Received | 2018-10-01 |
| Operator | LAY USER/PATIENT |
| Device Availability | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PRESTIGE BRANDS INC. |
| Manufacturer Address | 660 WHITE PLAINS ROAD 2ND FLOOR TARRYTOWN NY 10591 US 10591 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Life Threatening; 3. Other | 2018-10-01 |