Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2020-1510

2. Registrant Information.

Registrant Reference Number: USA-BAYERBAH-2020-US0014368 (Report 629381)

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.

12-APR-20

5. Location of incident.

Country: UNITED STATES

Prov / State: VIRGINIA

6. Date incident was first observed.

17-MAR-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. 11556-155

Product Name: Seresto Large 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 approximately 14-Mar-2020, a 10 year old, approximately 65 pound, neutered, female, Pit Bull crossbred dog, in unknown condition, with concomitant medical conditions of pruritus and fleas, had 1 Seresto Large Dog (Flumethrin-Imidacloprid) collar placed around the neck by the animal 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

Crossbred (Pit Bull x)

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

10

7. Weight (provide a range if necessary )

29.484

kg

8. Route(s) of exposure

Skin

9. What was the length of exposure?

>1 wk <=1 mo / > 1 sem < = 1 mois

10. Time between exposure and onset of symptoms

>24 hrs <=3 days / >24 h <=3 jours

11. List all symptoms

System

• Skin
  • Symptom - Lesion
  • Symptom - Hair loss

• Nervous and Muscular Systems
  • Symptom - Muscle tremors

• Gastrointestinal System
  • Symptom - Bloating
  • Symptom - Vomiting

• General
  • Symptom - Death

• Skin
  • Symptom - Other
  • Specify - purulent lesion

12. How long did the symptoms last?

Unknown / Inconnu

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 approximately 17-Mar-2020, the dog exhibited a skin lesion, a purulent lesion and hair loss, all localized to the face. An unspecified spray was applied to the affected area daily by the animal owner. On approximately 21-Mar-2020, the purulent lesion was healed on the face, but the dog exhibited tremors, application site mucopurulent discharge, an application site skin lesion and application site hair loss. An unspecified spray was applied to the affected area daily by the animal owner. On approximately 07-Apr-2020, the tremors resolved. The dog exhibited a localized skin lesion, a purulent lesion, hair loss and intermittent emesis. The collar was removed. On 13-Apr-2020, the dog exhibited a bloated abdomen. The dog was evaluated by a veterinarian, no treatments were provided and the dog died. No necropsy was performed.

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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 skin disorders (all localized to the face) are not typically seen with topical product administration. Though initial pruritus may be seen with collar use, other skin disorders are not expected. Time to onset is consistent for initial signs while long for later, additionally reported localized skin lesion, a purulent lesion and hair loss. Transient mild application site disorders may occur in sensitive animals after product application but the described application site mucopurulent discharge is not typically seen with product use. Unclear if correct fit of collar was checked periodically as recommended in the product information and thus development of signs not noticed. In this case, concomitant medical condition of pruritus may have contributed to the earlier described signs. Reported tremors are 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 which was not reported only transient gastrointestinal signs are expected. Time to onset is consistent. Emesis is unspecific and may have numerous other causes (e.g. gastrointestinal infection, dietary incompatibility). Though mild gastrointestinal signs may occur shortly after product application, they are not expected to appear with long time to onset. But bloated abdomen is not expected with topical product application. Later reported 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. Time to onset is long. Moreover, bloated stomach and death are reported long time after collar removal. Thus, other unrelated causes must be considered in this geriatric dog. Considering all aspects, a product relation is unassessable.