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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2019-3135

2. Registrant Information.

Registrant Reference Number: USA-BAYERBAH-2019-US0022791 (Report 564170)

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-MAY-19

5. Location of incident.

Country: UNITED STATES

Prov / State: WISCONSIN

6. Date incident was first observed.

15-MAY-19

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. 11556-155

Product Name: Seresto Large Dog (Flumethrin-Imidacloprid) collar

  • Active Ingredient(s)
    • FLUMETHRIN
      • Guarantee/concentration 4.5 %
    • IMIDACLOPRID
      • Guarantee/concentration 10 %

7. b) Type of formulation.

Other (specify)

COLLAR

Application Information

8. Product was applied?

Yes

9. Application Rate.

1

Other Units: COLLAR

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 14-May-2019, a 13 year old, 80 pound, neutered, male, Border Collie crossbred canine, in unknown condition, with concomitant medical condition of a hip joint disorder, had 1 Seresto Large Dog (Flumethrin-Imidacloprid) collar placed around the neck 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

Border Collie X crossbred

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

13

7. Weight (provide a range if necessary )

36.287

kg

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

>8 hrs <=24 hrs / > 8 h < = 24 h

11. List all symptoms

System

  • Gastrointestinal System
    • Symptom - Constipation
    • Specify - Behavioural disorder NOS
  • Renal System
    • Symptom - Anuria
    • Specify - Not urinating
  • General
    • Symptom - Lethargy
  • Nervous and Muscular Systems
    • Symptom - Muscle weakness
  • Respiratory System
    • Symptom - Panting
  • General
    • Symptom - Polydipsia
    • Symptom - Death

12. How long did the symptoms last?

Persisted until death

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 15-May-2019, the dog exhibited the behavior of not wanting to go outside, not urinating and the behavior of not defecating. On 16-May-2019, the dog exhibited lethargy, muscle weakness, panting and increased drinking. The not urinating resolved. The collar was removed. No medical intervention was sought and the clinical signs continued. Follow up received on 21 May 2019: On 16-May-2019, the collar was removed and the canine died approximately 3 hours post collar removal. No medical treatment was sought and no known 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 Reported behavioural disorders and lethargy are unspecific signs and may have numerous other causes. Signs may occur initially after collar administration. Further, reported panting, increased drinking and muscle weakness are not expected after appropriate product application. Death is not expected following appropriate topical product application as inconsistent with product's pharmacological profile. Oral exposure to the collar is not expected to cause serious signs either. An overdose of 5 collars around the neck was investigated in adult cats and dogs for an 8 months period and in 10 week old kittens and 7 week old puppies for a 6 months period without causing serious signs. This is supported by the extremely low systemic exposure with imidacloprid and flumethrin, particularly during the first week after application and also thereafter. No signs of anaphylaxis reported which would have occurred in close proximity to the collar application. Time to onset is consistent. Other causes should be consider in this geriatric dog. Considering overall aspects, a product connection for the case is considered unassessable.