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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2018-6832

2. Registrant Information.

Registrant Reference Number: 2018CP262

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


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. 29780      PMRA Submission No.       EPA Registration No.

Product Name: K9advantixII large 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).

On 09-Sep-2018, a 63 year old, woman, in unknown condition, with concomitant medical conditions of asthma and chronic Pain, was exposed to an unknown amount of K9AdvantixII when she snuggled with her dog while she slept after the product had been applied.

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: >19 <=64 yrs / >19 <=64 ans

3. List all symptoms, using the selections below.


  • Skin
    • Symptom - Tingling skin

4. How long did the symptoms last?

>8 hrs <=24 hrs / > 8 h < = 24 h

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

What was the activity? exposed when she snuggled with her dog while she slept after the product had been applied.

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?

Unknown / Inconnu

12. Time between exposure and onset of symptoms.

>8 hrs <=24 hrs / > 8 h < = 24 h

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.)

On 10-Sep-2018, the individual experienced a tingling sensation on the left side of her face from the cheek down, so she washed her face with an unspecified soap for approximately 15 minutes. The individual was not examined by a physician and the clinical sign continued. Due to this is non- US registered product, no more information is expected and this case is closed. Note: Advantix Plus Spot-on 2.5 ml (1100 mg Perm / 220 mg Imi / 11 mg Pyri) Dog 10-25 kg applied.

To be determined by Registrant

14. Severity classification.


15. Provide supplemental information here.

A - Probable - Patient was exposed to product when she snuggled with her dog while she slept after the product had been applied. Though it is unknown if left side of face of the patient was exposed to application site on the dog. However, considering short time to onset, reported tingling sensation on the left side of her face from the cheek down is indicative of paresthesia induced by permethrin. Considering all aspects, a product connection is deemed to be probable. Preliminary assessment. Pending the final assessment after evaluation by Medical doctor. If assessment is changed, the final statement will be submitted.