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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2018-1057

2. Registrant Information.

Registrant Reference Number: 2018CP011

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.

31-JAN-18

5. Location of incident.

Country: CANADA

Prov / State: QUEBEC

6. Date incident was first observed.

09-JAN-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.       PMRA Submission No.       EPA Registration No. Unknown

Product Name: advantage II pipette size unknown

  • Active Ingredient(s)
    • IMIDACLOPRID
    • PYRIPROXYFEN

7. b) Type of formulation.

Application Information

8. Product was applied?

Yes

9. Application Rate.

Unknown

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).

January 8, a 52 kg, 8 year old female neutered canine Rottweiler , was applied one tube advantageII unknown size once by the pet owner.

To be determined by Registrant

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

Unknown

Subform III: Domestic Animal Incident Report

1. Source of Report

Medical Professional

2. Type of animal affected

Dog / Chien

3. Breed

Rottweiler

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

8

7. Weight (provide a range if necessary )

52

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

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

11. List all symptoms

System

  • Eye
    • Symptom - Red eye
    • Symptom - Other
    • Specify - Uveitis
    • Symptom - Other
    • Specify - Blindness

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

The day after application, dog was had red eyes; on January 10 the dog had bilateral uveitis and was non visual; dog was examined by a veterinarian on January 12 and treated with oral anti inflammatories. unknow outcome.


To be determined by Registrant

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

Moderate

19. Provide supplemental information here

O - Unclassifiable/unassessable Reported eye redness is not anticipated with appropriate topical product application. Ocular exposure was not observed. Red eyes and later reported blindness in this case likely associated with uveitis. Bilateral uveitis is not expected, as inconsistent with the pharmaco-toxicological product profile. Other causes should be considered, e.g. immune-mediated (uveo-dermatologic syndrome has been reported in Rottweilers), underlying infectious or metabolic disease. Though time to onset is short for initially reported eye redness, association in time does not fit well for uveitis and blindness. Considering all aspects, a product relation is unassessable.