Nouvelle déclaration d'incident
No de la demande: 2016-4098
Numéro de référence du titulaire d'homologation: 1833688
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: GEORGIA
Inconnu
ARLA No d'homologation ARLA No de la demande d'homologation EPA No d'homologation. 4822-397
Nom du produit: OFF! Deep Woods Sportsmen Insect Repellent 11 6oz
Oui
Inconnu
Site: Personal use / Usage personnel
Personne affectée
Sexe: Homme
Âge: >64 yrs / > 64 ans
Système
Unknown / Inconnu
Oui
Non
Inconnu
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
Inconnu
Peau
>1 mo <= 6 mos / > 1 mois < = 6 mois
>2 mos <=6 mos / > 2 mois < = 6 mois
6/1/2016 Caller has used product for many years. About 3 years ago, caller got product into a scratch on his upper thigh. He was diagnosed with basal cell carcinoma in the same area. The shape of the carcinoma is the same as the scratch. Two dermatologists have told him it is related to N,N-Diethyl-meta-toluamide. He had surgery in May 2014 to remove the carcinoma. The site remained swollen after surgery and had misformed tissue. He saw a second physician in November 2015 and they thought it was scar tissue. He followed up again in November 2016 and the physician indicated it was scar tissue. A biopsy was performed in April 2016. It has returned, and he will be having another surgery in a few weeks. 6/21/2016 Attempted call back to the original caller. A message was left requesting follow up information. 6/23/2016 Attempted call back to the original caller. A message was left requesting follow up information. Caller is returning the previous message. Caller had another surgery performed by a mole surgeon on 6/15/2016, and a biopsy was performed during the surgery. There is a 5 inch incision on his leg due to the carcinoma which went down to his muscle. The incision is slowly healing.
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. Any relationship between the use of this product and the delayed development of the complications reported in this case is inconceivable and lacks biological plausibility. When considering the body of regulatory data and post-marketing data as well as the weight of scientific peer reviewed evidence on the active ingredients used in this product such a causal relationship appears to be scientifically implausible.