Nouvelle déclaration d'incident
No de la demande: 2016-4708
Numéro de référence du titulaire d'homologation: 1841446
Nom du titulaire (nom légal complet, aucune abbréviation): Bell Laboratories, Inc.
Adresse: 3699 Kinsman Blvd
Ville: Madison
État: WI
Pays: USA
Code postal /Zip: 53704
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. 12455-5-3240
Nom du produit: Tomcat All Weather Bait Chunx
Appât
Oui
Inconnu
Site: Res. - Out Home / Rés - à l'ext.maison
Non
Personne affectée
Sexe: Femme
Âge: >64 yrs / > 64 ans
Système
>1 wk <=1 mo / > 1 sem < = 1 mois
Oui
Oui
4
Day(s) / Jour(s)
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
>1 mo <= 6 mos / > 1 mois < = 6 mois
Unknown / Inconnu
On 6/11/2016 a (age) year old woman with a medical history of hypertension and hyperlipidemia and an unspecified gastrointestinal issue called the products medical information provider. The caller was currently taking the following medications: Plavix (blood thinner), Prilosec, Premarin, and Lotrel. She reported that she had been using the product for rodent control outside her residence since November, 2015. She would break the blocks in half with her bare hands and then nail half a block to the inside of a bait station that was placed outside her home. After handling the product, she would rinse her hands. She estimates that she had used about 10 boxes of product but did not know the size of the boxes. She had recently read online that the product becomes activated with wet and she wanted to know if she was putting herself at risk by not wearing gloves when handling the product and also by rinsing her hands. She also reported that she was hospitalized for 3-4 days in either March or April, 2016 because of low blood pressure, weakness, chronic diarrhea, and dehydration. She was treated with intravenous fluids, potassium, and antibiotics. In addition to this, shes been having intermittent periods of dizziness and lethargy for the past 2-3 months. In early June, 2016 she developed light menstrual spotting although she has been post-menopausal for 10 years. The bleeding became heavier so she underwent a pelvic and abdominal ultrasound on approximately June 9. The caller was advised that the product does not become activated when mixed with water and is not absorbed through the skin; however, she should follow all personal protective wear requirements as listed on the package. As the product is an anti-coagulant, she was advised to inform her physician of her use of the product so s/he could determine whether or not they wished to pursue coagulation tests. On a follow up call placed on 6/21/16 the caller stated that she was feeling much better and that her lethargy and dizziness had resolved. Her physician informed her that her symptoms were not due to her handling of the product and that she has an unrelated uterine issue. She is due be treated with a dilation and curettage procedure. Her physician preformed per-surgical lab work, including a coagulation panel, and all values came back normal. She will continue to be monitored by her physician and have regularly scheduled lab work at his direction. NOTE TO PMRA: When filling out this individual report, there appears to be a glitch in the symptom field. When reproductive was selected as a system, I was unable to open the corresponding symptom drop down menu. I tried deleting the symptom and also tried closing and reopening the form but neither of these actions solved the problem. Ultimately, instead of coding the vaginal spotting symptoms under reprodutive as they should be, I opted to write this out under a general system code.
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.