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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2020-2844

2. Registrant Information.

Registrant Reference Number: USA-BAYERBAH-2020-US0031821 (Report 648089)

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.

30-JUN-20

5. Location of incident.

Country: UNITED STATES

Prov / State: UNKNOWN

6. Date incident was first observed.

23-JUN-20

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. 11556-141

Product Name: K9advantixII small dog

  • Active Ingredient(s)
    • IMIDACLOPRID
      • Guarantee/concentration 8.8 %
    • PERMETHRIN
      • Guarantee/concentration 44 %
    • PYRIPROXYFEN
      • Guarantee/concentration .44 %

7. b) Type of formulation.

Other (specify)

spot-on

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).

On 21-Jun-2020, a 1 year old, male, Persian/Munchkin crossbred feline, of unknown weight, reproductive status and condition, with concomitant medical conditions of fleas, was exposed to an unknown amount of K9 Advantix II Small Dog (Imidacloprid-Permethrin-Pyriproxyfen) that was applied to a house mate.

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

Persian/Munchkin crossbred

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

1

7. Weight (provide a range if necessary )

Unknown

8. Route(s) of exposure

Skin

9. What was the length of exposure?

>24 hrs <=3 days / >24 h <=3 jours

10. Time between exposure and onset of symptoms

>24 hrs <=3 days / >24 h <=3 jours

11. List all symptoms

System

  • Nervous and Muscular Systems
    • Symptom - Ataxia
  • Renal System
    • Symptom - Urinary incontinence
  • Gastrointestinal System
    • Symptom - Fecal incontinence
  • General
    • Symptom - Vocalizing
    • Symptom - Death

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?

Other / Autre

specify Accidental exposure

17. Provide any additional details about the incident

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

On approximately 23-Jun-2020 the cat exhibited ataxia, urinary incontinence and fecal incontinence, vocalization, and died. No necropsy was performed. No more information is expected. Case is closed.


To be determined by Registrant

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

Death

19. Provide supplemental information here

B - Possible Off-label Use (Secondary contact with treated animal). Reported ataxia and time to onset are consistent with permethrin toxicity in cats. Contact with a recently treated animal was confirmed. Vocalization is an unspecific sign, however, may be a behavioural response to the feeling caused by the applied product. Urinary and faecal incontinence are not expected, however, may be associated with neurological sign. With timely and intensive treatment, death is usually preventable. Onset time is consistent. However, other causes should also be considered in this case as multiple animals in household showed the same signs. In the end, a product relation cannot be ruled out and is deemed to be possible.