Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2019-7162

2. Registrant Information.

Registrant Reference Number: USA-BAYERBAH-2019-US0067531 (Report 610130)

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.

13-NOV-19

5. Location of incident.

Country: UNITED STATES

Prov / State: FLORIDA

6. Date incident was first observed.

Unknown

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. 11556-155

Product Name: Seresto Small Dog

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

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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 07-Nov-2019, a 12 year old, 5.5 pound, neutered, female, Yorkshire Terrier canine, in unknown condition, with the concomitant medical conditions of allergies, unknown skin disorder and pruritus, 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

Yorkshire Terrier

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

12

7. Weight (provide a range if necessary )

2.495

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

• General
  • Symptom - Lethargy

• Gastrointestinal System
  • Symptom - Anorexia

• Skin
  • Symptom - Rash

• Nervous and Muscular Systems
  • Symptom - Ataxia

• General
  • Symptom - Death

• Gastrointestinal System
  • Symptom - Vomiting

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 08Nov2019, the canine was lethargic. On 10Nov2019, the canine was anorexic and the collar was removed. On 11Nov2019, the canine was ataxic, vomiting, and developed a skin rash along the dorsum. The canine was bathed in an unknown baby shampoo by the owner. On 12Nov2019, the canine died. No medical intervention was sought and no necropsy was performed. No more information is expected. This 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

O - Unclassifiable/unassessable Reported lethargy and anorexia are unspecific and may have numerous other causes. Time to onset is short. However, signs may be associated with other reported signs in this advanced age dog. Ataxia is not typically seen with appropriate topical product administration. This is supported by the extremely low systemic exposure with imidacloprid and flumethrin, particularly during the first week after application and also thereafter. Even with oral product exposure only transient gastrointestinal signs are expected. Vomiting is unspecific and may have various other causes. Further reported skin rash other than application site is not expected. Though initial pruritus may be seen with collar use, other skin disorders are not expected. Other causes (e.g. concomitant skin disorders, pruritus and allergies) have to be considered as well. Ataxia, vomiting, skin rash and further death are reported after collar removal. Nevertheless 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. As time to onset is consistent for first signs but long for further signs and death, finally a product relation is considered unassessable.