Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2019-3602

2. Registrant Information.

Registrant Reference Number: USA-BAYERBAH-2019-US0033328 (Report 575505)

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.

21-JUN-19

5. Location of incident.

Country: UNITED STATES

Prov / State: UNKNOWN

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)

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PMRA Registration No. 27586      PMRA Submission No.       EPA Registration No. 11556-152

Product Name: Advantage II Large Cat (0.8 ml Cat > 4 kg)

• Active Ingredient(s)
  • IMIDACLOPRID
    • Guarantee/concentration 9.1 %
  • PYRIPROXYFEN
    • Guarantee/concentration .46 %

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7. b) Type of formulation.

Liquid

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 an unknown date in 2019, an 18 year old, neutered, female, Himalayan/Siamese crossbred feline, in unknown condition, with no known concomitant medical conditions, was administered 1 tube of Advantage II Large Cat (Imidacloprid-Pyriproxyfen) topically by the 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

Animal's Owner

2. Type of animal affected

Cat / Chat

3. Breed

Himalayan/Siamese crossbred

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

18

7. Weight (provide a range if necessary )

Unknown

8. Route(s) of exposure

Skin

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

Unknown / Inconnu

11. List all symptoms

System

• Gastrointestinal System
  • Symptom - Weight loss

• General
  • Symptom - Lethargy

• Nervous and Muscular Systems
  • Symptom - Agitation

• Respiratory System
  • Symptom - Other
  • Specify - Decreased respiratory rate

• General
  • Symptom - Death

• Eye
  • Symptom - Decreased pupillary light reflex
  • Specify - no pupillary light reflex

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

Died

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

On an unknown date post application in approximately 2019, the feline started to exhibit weight loss. On 20-Jun-2019 the feline was bathed with oatmeal shampoo by the owner and then had 1 tube of Advantage II Large Cat (Imidacloprid-Pyriproxyfen) topically by the owner. On 21-Jun-2019 the feline became lethargic. The owner called the veterinarian who recommended he wash the application site. The owner washed the application site and the feline's condition worsened. The feline was agitated, had a decrease in respiratory rate, no pupillary light reflex, stopped breathing, and died. The feline was not examined by a veterinarian and no known necropsy was performed.

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To be determined by Registrant

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

Death

19. Provide supplemental information here

O - Unclassifiable/unassessable: Reported weight loss is not expected after product administration. Time to onset is unknown. Other causes must be considered. Lethargy and agitation after reapplication of the product are unspecific and may have numerous other causes. Later reported decrease in respiratory rate, no pupillary light reflex, stopped breathing and death are not expected either and are inconsistent with the pharmacological product profile. Product has wide margin of safety. Oral LD50 in rat is 642 mg/kg BW. 24-fold overdosage tolerated by cats without showing any side effect. Other causes must be considered in this geriatric cat. Though, time to onset is short, considering overall aspects and limited information (e.g. medical history, health status and necropsy details), a product involvement is unassessable.