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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2019-0328

2. Registrant Information.

Registrant Reference Number: USA-BAYERBAH-2018-US0070667 (Report 537582)

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.

03-DEC-18

5. Location of incident.

Country: UNITED STATES

Prov / State: UNKNOWN

6. Date incident was first observed.

27-OCT-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 Large 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 approximately 26-Oct-2018, a 8 year old, 49 pound, neutered, female, Bulldog canine, in unknown condition, with no known concomitant medical conditions, had 1 Seresto Large Dog (Flumethrin-Imidacloprid) collar placed around the neck by the owner. An unknown dose of a moxidectin injection had been administered on 09 Oct 2018.

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

Bulldog

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

8

7. Weight (provide a range if necessary )

22.226

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

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

11. List all symptoms

System

  • Respiratory System
    • Symptom - Difficulty Breathing
  • General
    • Symptom - Weakness
  • Gastrointestinal System
    • Symptom - Anorexia
  • General
    • Symptom - Death
  • Nervous and Muscular Systems
    • Symptom - Difficulty walking
  • General
    • Symptom - Other
    • Specify - Abnormal radiograph finding

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 27 Oct2018, the canine developed difficulty breathing and anorexia. On 29 Oct 2018, breathing worsened and the canine was examined by a veterinarian. Radiographs, electrolytes, heartworm testing, urinalysis, ultrasound, fungal testing including histoplasmosis, and an unspecified antigen test were performed. The radiographs were "milky" according to the owner and all other test were with in normal limits. The canine was started on a treatment regiment of amoxicillin/clavulanic acid and enrofloxacin 68 mg. On 30 Oct 2018, the collar was removed. On 31 Oct 2018, the dog anorexia continued and the dog was weak and unable to walk. On 01 Nov 2018, appetite was improving. On 09 Nov 2018, the dog was re-examined by a veterinarian. Follow up radiographs were performed and changes in the lungs appeared resolved. Theophyline was advised. On 16 Nov 2018, theophylline 150 mg was initiated. On 19 Nov 2018, the canine died. No necropsy was performed. No more medical information is expected. The 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 Reported breathing difficulty is not expected following appropriate topical product application as inconsistent with product's pharmacological profile. Weakness and anorexia are unspecific and may have numerous other causes. Time to onset is Short for these signs. Abnormal radiograph finding is neither expected nor inline with products pharmaco-toxicological profile. Neurological signs are not typically seen with appropriate topical product administration. Walking difficulty is related to weakness rather than true neurological signs. Further reported death is also 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. Time to onset is long. No necropsy performed. Other causes must be considered in animal with unknown health condition. Overall, considering all aspects a product relation is remains unassessable.