Nouvelle déclaration d'incident
No de la demande: 2025-3516
Numéro de référence du titulaire d'homologation: 4033295
Nom du titulaire (nom légal complet, aucune abbréviation): S.C. Johnson and Son, Limited
Adresse: 1 Webster Street
Ville: Brantford
État: ON
Pays: Canada
Code postal /Zip: N3T 5R1
Incident chez l'humain
Pays: UNITED STATES
État: LOUISIANA
Inconnu
ARLA No d'homologation ARLA No de la demande d'homologation EPA No d'homologation. Inconnu
Nom du produit: OFF! Deep Woods - non-specific
Liquide
Oui
Inconnu
Site: Personal use / Usage personnel
Inconnu
Personne affectée
Sexe: Homme
Âge: >19 <=64 yrs / >19 <=64 ans
Système
Unknown / Inconnu
Oui
Non
Non professionnel
Application
Quelle était l'activité? Please refer to field 13 on Subform II or field 17 of subform III for a detailed description regarding the activity
Aucun
Peau
Unknown / Inconnu
>30 min <=2 hrs / >30 min <=2 h
7/25/2025 Caller reports experiencing tonic-clonic seizure, stopped breathing, lightheaded, dizziness, slurred speech, and memory impairment after use of OFF! Deep Woods - non-specific. He states that as a kid the product was always around for when they went fishing or did things outdoors. In approximately 2003, when he was 16 years old, he was fishing on a lake with his dad. He used the product as directed. One hour later, he experienced a seizure and stopped breathing for about 1.5-2 minutes. He saw a Neurologist and had electroencephalogram, Magnetic resonance imaging, computerized tomography scan, and sleep studies. All results came back normal. He reports that he was advised that he did not have epilepsy and they were unsure why he had the seizure. In 05/2025 he went with his wife and two daughters to their property in another state to go fishing and hiking. On 05/04/2025 his wife and daughters used the product but he did not. When they got back to their camper that night he had ticks on him so he decided that he was going to use the product the next day to keep them away. On 05/05/2025, he was wearing shorts and a t-shirt. He applied the product to exposed skin areas. About 20 minutes later they stopped at an outfitter's store to get snacks and drinks. While in the store he began experiencing lightheaded, dizziness where he felt like he was going to pass out, and slurred speech. He told his wife that he did not feel right. His symptoms worsened while they were checking out at the register. The asked for directions to the nearest hospital. He notes that he does not recall much after this, but his wife obtained the security camera footage from the store and he watched this later. He states that he had a tonic-clonic seizure lasting about 2-2.5 minutes and stopped breathing for about 1.5 minutes. A customer that was a nurse came into the store and assisted him and someone called an ambulance. He reports that he recalls briefly waking up in the ambulance and was given intravenous saline. He saw a neurologist. He notified his provider regarding product use. He states that they wanted to prescribe Keppra for an epilepsy diagnosis to keep seizures away. He does not believe that he has epilepsy as he has only had two seizures in his life that were 22 years apart. He declined the medication due to concerns of side effects. His doctor asked if there were any commonalities between the two seizures. He was unable to identify anything at the time. He is following up with his Neurologist every 6 months. He states that later he realized that he was fishing both times and had used the product. He last used the product on 05/05/2025. He is a business owner/project manager and was unable to work for 2 months. His short-term memory was poor after the event, with a 2-3 minute recall, and this is gradually improving over time.
Majeure
The information contained in this report is based on self-reported statements provided to the registrant during telephone Interview(s). These self-reported descriptions of an incident have not been independently verified to be factually correct or complete descriptions of the incident. For that reason, information contained in this report does not and can not form the basis for a determination of whether the reported clinical effects are causally related to exposure to the product identified in the telephone interviews.