Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2020-2847

2. Registrant Information.

Registrant Reference Number: USA-BAYERBAH-2020-US0031842 (Report 648106)

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.

28-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)

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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 %

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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 21-Jun-2020, a 6 year old, 3.5 pound, female, Yorkshire Terrier canine, of unknown reproductives status and condition, with a concomitant medical condition of fleas, was administered 1 tube of K9 Advantix II Small Dog (Imidacloprid-Permethrin-Pyriproxyfen) topically by the 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

Dog / Chien

3. Breed

Yorkshire Terrier

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

6

7. Weight (provide a range if necessary )

1.588

kg

8. Route(s) of exposure

Skin

9. What was the length of exposure?

>3 days <=1 wk / >3 jours <=1 sem

10. Time between exposure and onset of symptoms

>3 days <=1 wk / >3 jours <=1 sem

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?

Treatment / Traitement

17. Provide any additional details about the incident

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

On approximately 28-Jun-2020, the dog exhibited ataxia, urinary and fecal incontinence, vocalization and died. No necropsy was performed. No more information is expected. The 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

N - Unlikely Off label use: (Unauthorized species sub group). Even though more expected after oral uptake, permethrin has the potential to cause mild, transient neurological disorder like ataxia in particularly susceptible animals. Time to onset is long (7 days). Vocalization is unspecific and may be associated to other reported signs. Urinary incontinence, fecal incontinence and death are not expected, as it is inconsistent with the pharmaco-toxicological profile of the product. Time to onset is more than 12 hours, therefore an allergic/anaphylactic-type reaction can be ruled out. No necropsy was performed. Other causes should be considered. Overall, a product relation is considered unlikely.