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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2020-2839

2. Registrant Information.

Registrant Reference Number: USA-BAYERBAH-2020-US0031545 (Report 647959)

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.

29-JUN-20

5. Location of incident.

Country: UNITED STATES

Prov / State: NORTH CAROLINA

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.       PMRA Submission No.       EPA Registration No. Unknown

Product Name: Advantage II Small Cat

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

7. b) Type of formulation.

Other (specify)

Spot-on

Application Information

8. Product was applied?

Yes

9. Application Rate.

.4

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 approximately 2019, an approximately 17 year old, neutered, female cat, of unknown weight and breed, with the concomitant medical condition of an unspecified hip issue, was administered 1 tube of Advantage II Large Cat (Imidacloprid-Pyriproxyfen) via the topical route by the animal owner. On approximately 28-May-2020, the cat, now approximately 8 pound, with visible fleas, was administered 1 tube of Advantage II Small Cat (Imidacloprid-Pyriproxyfen) via the topical route by the animal owner. On 26-Jun-2020, the cat was administered 1 tube of Advantage II Small Cat (Imidacloprid-Pyriproxyfen) via the topical route by the animal owner.

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

Animal's Owner

2. Type of animal affected

Cat / Chat

3. Breed

Unknown

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

17

7. Weight (provide a range if necessary )

3.63

kg

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 - Anorexia
  • General
    • Symptom - Death
  • Gastrointestinal System
    • Symptom - Weight loss

12. How long did the symptoms last?

Unknown / Inconnu

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

No

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 unspecified date post application, in approximately 2019, the cat exhibited an unspecified amount of weight loss. On approximately 24-Jun-2020, the cat developed anorexia. On 27-Jun-2020, the cat died at home. No necropsy was performed.


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 Weight loss is not expected with product application. Time to onset is unknown. Other causes must be considered. Fleas were reported in a single incidence after application of first pipette. Presence of fleas is not a sign of inefficacy. Regular treatments for at least a 6-week period are necessary in order to break the flea development circle. Otherwise preexisting pupae may still emerge from the environment and re-infest the pet. Efficacy against fleas can be expected only after this period. Though later reported anorexia is an unspecific sign and may have multiple potential other causes in an animal, it may represent a behavioural response to the product sensation. Time to onset is long after second pipette application. Other causes are more probable. Death is not expected after product application, as inconsistent with pharmaco-toxicological product profile. Oral exposure to the product is not expected to cause serious conditions leading to death either. The product was administered to puppies/kittens at up to 5 times the recommended dose, every 2 weeks for 6 treatments and there were no serious safety concerns. No signs of allergy/anaphylactic reaction. Time to onset for death is short after subsequent pipette application. Other unrelated causes must be considered in this geriatric cat with unknown health status. Overall, product relation to the case is unassessable.