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Consumer Product Safety

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.


4. Date registrant was first informed of the incident.


5. Location of incident.

Country: CANADA

Prov / State: ONTARIO

6. Date incident was first observed.


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.


PMRA Registration No. 29777      PMRA Submission No.       EPA Registration No.

Product Name: K9advantixII small dog

  • Active Ingredient(s)

7. b) Type of formulation.

Application Information

8. Product was applied?


9. Application Rate.


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?


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.


  • Skin
    • Symptom - Rash
    • Symptom - Dermatitis

4. How long did the symptoms last?

Unknown / Inconnu

5. Was medical treatment provided? Provide details in question 13.


6. a) Was the person hospitalized?


6. b) For how long?

7. Exposure scenario


8. How did exposure occur? (Select all that apply)

Contact with treated area


9. If the exposure occured during application or re-entry, what protective clothing was worn? (select all that apply)


10. Route(s) of exposure.


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.


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.