Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2018-5873
2. Registrant Information.
Registrant Reference Number: 2018BS032
Registrant Name (Full Legal Name no abbreviations): Bayer inc
Address: 2920 Matheson Blvd
City: Mississaugua
Prov / State: ON
Country: Canada
Postal Code: L4W 5R6
3. Select the appropriate subform(s) for the incident.
Human
4. Date registrant was first informed of the incident.
11-JUL-18
5. Location of incident.
Country: CANADA
Prov / State: ONTARIO
6. Date incident was first observed.
06-JUN-18
Product Description
7. a) Provide the active ingredient and, if available, the registration number and product name (include all tank mixes). If the product is not registered provide a submission number.
Active(s)
PMRA Registration No. 29777
PMRA Submission No.
EPA Registration No.
Product Name: K9advantixII small dog
- Active Ingredient(s)
- IMIDACLOPRID
- PERMETHRIN
- PYRIPROXYFEN
7. b) Type of formulation.
Application Information
8. Product was applied?
Yes
9. Application Rate.
.4
Units: mL
10. Site pesticide was applied to (select all that apply).
Site: Animal / Usage sur un animal domestique
11. Provide any additional information regarding application (how it was applied, amount applied, the size of the area treated etc).
Owner apply K9 advantix II small to dog (name) a 10month old, f/s, 3.5kg, Pomeranian along the dorsal midline in 4 spots on June 3/18. On July 3/18 she applied another dose.
To be determined by Registrant
12. In your opinion, was the product used according to the label instructions?
Yes
Subform II: Human Incident Report (A separate form for each person affected)
1. Source of Report.
Data Subject
2. Demographic information of data subject
Sex: Female
Age: Unknown / Inconnu
3. List all symptoms, using the selections below.
System
- Skin
- Symptom - Rash
- Symptom - Dermatitis
4. How long did the symptoms last?
Unknown / Inconnu
5. Was medical treatment provided? Provide details in question 13.
Yes
6. a) Was the person hospitalized?
No
6. b) For how long?
7. Exposure scenario
Non-occupational
8. How did exposure occur? (Select all that apply)
Contact with treated area
Other
9. If the exposure occured during application or re-entry, what protective clothing was worn? (select all that apply)
Unknown
10. Route(s) of exposure.
Skin
11. What was the length of exposure?
>1 mo <= 6 mos / > 1 mois < = 6 mois
12. Time between exposure and onset of symptoms.
>24 hrs <=3 days / >24 h <=3 jours
13. Provide any additional details about the incident (eg. description of the frequency and severity of the symptoms, type of medical treatment, results from medical tests, outcome of the incident, amount of pesticide exposed to, etc.)
3 days later, the owner noticed an itchy rash on the inside of her left arm and upper chest and was itchy and present for about 3 weeks. On July 3/18 she applied another dose to Molly and the owner noticed the rash reappeared on her inside left arm, chest and throat area. Animal owner was examined by her GP on July 9th and was diagnosed with contact dermatitis. She is taking Benedryl for the itching and applying a natural product called Sage:Allergy Relief containing essential oils.
To be determined by Registrant
14. Severity classification.
Moderate
15. Provide supplemental information here.
O - Unclassifiable/unassessable Accidental indirect exposure. Contact with treated dog. Affected areas (left arm, upper chest and throat area) are not compatible with exposed area (hands while applying the product). Though, contact of body with hands cannot be excluded, reported signs are uncommon and are likely a consequence of diagnosed contact dermatitis, which may have many causes. Even though time to onset is long for initially reported signs, overall, considering unknown time to onset for later reported skin disorders, a product connection is unassessable. Preliminary assessment. Pending the final assessment after evaluation by medical doctor. If assessment is changed, the final statement will be submitted.