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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2018-6751

2. Registrant Information.

Registrant Reference Number: USA-BAYERBAH-2018-US0069401 (Report 535995)

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-NOV-18

5. Location of incident.

Country: UNITED STATES

Prov / State: UNKNOWN

6. Date incident was first observed.

15-NOV-18

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 Small Dog

  • 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 an unknown date in 2018, a 14 year old, 9 pound, neutered, male, Chihuahua canine, in unknown condition, with concomitant medical conditions of hearing loss, cataracts and dental disease, had 1 Seresto Small 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

Chihuahua

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

14

7. Weight (provide a range if necessary )

4.082

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

  • General
    • Symptom - Death
  • Cardiovascular System
    • Symptom - Other
    • Specify - Congestive heart failure
  • Gastrointestinal System
    • Symptom - Anorexia
  • Nervous and Muscular Systems
    • Symptom - Ataxia

12. How long did the symptoms last?

Persisted until death

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

Yes

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 Nov 2018, the dog was examined by a veterinarian and diagnosed with congestive heart disease. The dog was started on an unknown dose of oral pimobendan daily. The clinical sign continued. On 18 Nov 2018, the dog was anorexic, ataxic and died. No known necropsy was performed. No more information is expected. This 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

O - Unclassifiable/unassessable Congestive heart disease is not expected following appropriate topical product application. Ataxia is not typically seen with appropriate topical product administration. Even with oral product exposure - which was not reported - only transient gastrointestinal signs are expected. Anorexia is unspecific and may be associated with underlying medical condition of the dog. 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. Other unrelated causes are more probable in this geriatric dog. Though time to onset for initial signs is unknown, however, it was rather long for later reported sign. This old dog (14-years) had concomitant medical conditions of hearing loss, cataracts and dental disease already before the Treatment and congestive heart disease is not unusual in a gog that age. Necropsy details were not reported. Considering all aspects a product relation is unassessable.