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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2019-2340

2. Registrant Information.

Registrant Reference Number: USA-BAYERBAH-2019-US0016593 (Report 558424)

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.

24-APR-19

5. Location of incident.

Country: UNITED STATES

Prov / State: MICHIGAN

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)

PMRA Registration No.       PMRA Submission No.       EPA Registration No. 11556-127

Product Name: Advantage Plus Spot-on 2.5 ml (250 mg Imi / 12.5 mg Pyri) Dog > 10-25

  • Active Ingredient(s)
    • IMIDACLOPRID
      • Guarantee/concentration 9.1 %
    • PYRIPROXYFEN
      • Guarantee/concentration .46 %

PMRA Registration No.       PMRA Submission No.       EPA Registration No.

Product Name: Seresto Large Dog collar

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

7. b) Type of formulation.

Other (specify)

spot on

Application Information

8. Product was applied?

Yes

9. Application Rate.

2.5

Units: mL

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 unspecified date in approximately 2018, a 17 year old, male, Shepherd Dog - Australian dog, of unknown weight, in unknown condition, with no known concomitant medical conditions, had one Seresto Large Dog collar (Flumethrin-Imidacloprid) placed around the neck and then was administered 1 tube of Advantage II Large Dog (Imidacloprid-Pyriproxyfen) applied via the topical route by the animal owner.

To be determined by Registrant

12. In your opinion, was the product used according to the label instructions?

Unknown

Subform III: Domestic Animal Incident Report

1. Source of Report

Animal's Owner

2. Type of animal affected

Dog / Chien

3. Breed

Australian Shepherd Dog

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

17

7. Weight (provide a range if necessary )

Unknown

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
  • Nervous and Muscular Systems
    • Symptom - Ataxia
    • Symptom - Stiffness
    • Specify - Stiff gait

12. How long did the symptoms last?

Unknown / Inconnu

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

Unknown

14. a) Was the animal hospitalized?

Unknown

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 an unspecified date in approximately 2018, post product application, the dog exhibited ataxia and a stiff gait and the collar was removed. On an unspecified date in approximately 2018, approximately 3 days post collar removal, the clinical signs resolved. On an unspecified date in approximately 2018, the dog died. No Necropsy was performed. Due to the sensitive nature of the communication, specific relevant details were not obtained, nor will they be sought. The intent of the call was to inquire about product use in general and not to report this event.


To be determined by Registrant

18. Severity classification (if there is more than 1 possible classification

Death

19. Provide supplemental information here

Sereso: O - Unclassifiable/unassessable Stiff gait is not expected after appropriate topical product application as inconsistant with products pharmaco-toxicological profile. 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. Time to onset is unknown. Further, death is not expected following appropriate topical product application as inconsistent with product's pharmacological profile. Moreover it was reported after collar removal. 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 causes are more likely in this geriatric dog of 17 years. Moreover the intent of the call was to inquire about product use in general and not to report this event. In summary, based on the provided information, product relation remains unassessable. Advantage: O - Unclassifiable/unassessable Stiff gait is not expected after appropriate topical product application as inconsistent with products pharmaco-toxicological profile. Ataxia is not typically observed with appropriate topical product administration. Death is inconsistent with pharmaco-toxicological product profile and experience. Product has wide margin of safety. The oral LD50 in rat is 642 mg/kg BW. 20-fold overdosage tolerated by dogs without showing any side effect. Other causes are more likely in this geriatric dog of 17 years. Moreover the intent of the call was to inquire about product use in general and not to report this event. Time to onset is unknown. Considering all aspects, product relation is unassessable.