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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2018-0236

2. Registrant Information.

Registrant Reference Number: 2017RB193

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.

Domestic Animal

4. Date registrant was first informed of the incident.

25-OCT-17

5. Location of incident.

Country: CANADA

Prov / State: ONTARIO

6. Date incident was first observed.

Unknown

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. 27586      PMRA Submission No.       EPA Registration No.

Product Name: Advantage II large cat

  • Active Ingredient(s)
    • IMIDACLOPRID
    • PYRIPROXYFEN

7. b) Type of formulation.

Application Information

8. Product was applied?

Yes

9. Application Rate.

.8

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 October 20, 2017 the pet owner applied Advantage II large cat to their 6.84 kg, 5.5 year old, male neutered domestic short haired cat as it had fleas.

To be determined by Registrant

12. In your opinion, was the product used according to the label instructions?

Yes

Subform III: Domestic Animal Incident Report

1. Source of Report

Medical Professional

2. Type of animal affected

Cat / Chat

3. Breed

Domestic Shorthair

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

5.5

7. Weight (provide a range if necessary )

6.84

kg

8. Route(s) of exposure

Skin

9. What was the length of exposure?

>1 wk <=1 mo / > 1 sem < = 1 mois

10. Time between exposure and onset of symptoms

>1 wk <=1 mo / > 1 sem < = 1 mois

11. List all symptoms

System

  • Skin
    • Symptom - Hair loss
    • Symptom - Other
    • Specify - Ulcerated skin
  • General
    • Symptom - Lethargy

12. How long did the symptoms last?

Unknown / Inconnu

13. Was medical treatment provided? Provide details in question 17.

Yes

14. a) Was the animal hospitalized?

No

14. b) How long was the animal hospitalized?

15. Outcome of the incident

Unknown/Inconnu

16. How was the animal exposed?

Treatment / Traitement

17. Provide any additional details about the incident

(eg. description of the frequency and severity of the symptoms

At some point after application the cat developed ulcerated skin and hair loss at the application site. The cat also became lethargic and may have ingested some of the Advantage II. The cat was seen by a veterinarian on October 25, 2017 and treated with a topical antibiotic. Another cat in the home was also treated with Advantage II and had no adverse reaction.


To be determined by Registrant

18. Severity classification (if there is more than 1 possible classification

Moderate

19. Provide supplemental information here

B-Possible: In individual case, dermal reaction (in this case, hair loss) at the application site is possible in animal that is particular sensitive. Would not expect application site ulcer directly related to the product however, likely dog scratched/ licked at site and caused skin lesion by self-trauma. Reported lethargy is an unspecific sign and may have multiple potential other causes in an animal. However in this case, sign may be consequence of other reported signs. Though exact time to onset is unknown, considering application site involvement, a product relation is possible.