Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2019-1878

2. Registrant Information.

Registrant Reference Number: USA-BAYERBAH-2019-US0009215 (Report 551789)

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.

20-MAR-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.       PMRA Submission No.       EPA Registration No. 11556-150

Product Name: Advantage II (kitten-unspecified)

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

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7. b) Type of formulation.

Other (specify)

spot on

Application Information

8. Product was applied?

Yes

9. Application Rate.

.23

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 unspecified date in 2018, a 3 year old, approximately 8 pound, pregnant non-lactating, female, Domestic Shorthair feline, in unknown condition, with no known concomitant medical conditions, was administered 1 tube of Advantage II (kitten-unspecified) (Imidacloprid-Pyriproxyfen) topically by the owner. This was used in an off label manner due to the feline being pregnant.

To be determined by Registrant

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

No

Subform III: Domestic Animal Incident Report

1. Source of Report

Animal's Owner

2. Type of animal affected

Cat / Chat

3. Breed

Domestic Shorthair

4. Number of animals affected

4

5. Sex

Unknown

6. Age (provide a range if necessary )

Unknown

7. Weight (provide a range if necessary )

Unknown

8. Route(s) of exposure

Unknown

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

Unknown / Inconnu

11. List all symptoms

System

• General
  • Symptom - Death
  • Symptom - Lethargy

• Respiratory System
  • Symptom - Difficulty Breathing

12. How long did the symptoms last?

Unknown / Inconnu

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

Unknown

14. a) Was the animal hospitalized?

Unknown

14. b) How long was the animal hospitalized?

15. Outcome of the incident

Died

16. How was the animal exposed?

Other / Autre

specify Product applied on pregnant animal.

17. Provide any additional details about the incident

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

On an unspecified date in 2018 post application the cat gave birth to 5 kittens. Four of the five kittens exhibited lethargy, difficulty breathing and died; one kitten each day for four days. It is unknown if a necropsy was preformed on the kittens. MAH comment: The intent of the call was to inquire about product use in general and not to report this event. No further information is expected. This case is closed.

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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 Lethargy is unspecific and may have other numerous causes. Breathing difficulty and death are not expected after product application, as inconsistent with pharmaco-toxicological product profile. No primary embryotoxic, teratogenic or reproductive toxic effects have been observed during the studies with imidacloprid on rats and rabbits. Studies on pregnant and lactating bitches together with their offspring are limited. Considering limited information (e.g. Medical history, state of health, time to onset and necropsy reports), a product relation is unassessable.