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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2018-3590

2. Registrant Information.

Registrant Reference Number: USA-BAYERBAH-2018-US0042571 (Report 509157)

Registrant Name (Full Legal Name no abbreviations): Bayer inc

Address: 2920 Matheson BLVD

City: Mississaugua

Prov / State: ON

Country: Canada

Postal Code: L5W5R6

3. Select the appropriate subform(s) for the incident.

Domestic Animal

4. Date registrant was first informed of the incident.


5. Location of incident.


Prov / State: FLORIDA

6. Date incident was first observed.


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.


PMRA Registration No.       PMRA Submission No.       EPA Registration No. 11556-155

Product Name: Seresto Collar unknown

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

7. b) Type of formulation.

Other (specify)


Application Information

8. Product was applied?


9. Application Rate.


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 unspecified date in approximately 2018, a 6 year old, 109 pound, neutered, male, German Shepherd Dog canine, in unknown condition, with no known concomitant medical conditions, had 1 Seresto Dog (unspecified) (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?


Subform III: Domestic Animal Incident Report

1. Source of Report

Animal's Owner

2. Type of animal affected

Dog / Chien

3. Breed

German Shepherd Dog

4. Number of animals affected


5. Sex


6. Age (provide a range if necessary )


7. Weight (provide a range if necessary )



8. Route(s) of exposure


9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

Unknown / Inconnu

11. List all symptoms


  • Nervous and Muscular Systems
    • Symptom - Paresis
    • Symptom - Recumbent
  • Skin
    • Symptom - Lesion
  • General
    • Symptom - Death
    • Symptom - Parasitism

12. How long did the symptoms last?

Persisted until death

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


14. a) Was the animal hospitalized?


14. b) How long was the animal hospitalized?


Day(s) / Jour(s)

15. Outcome of the incident


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 05Jul2018, the dog was examined by the veterinarian for unspecified illness. Radiographs and bloodwork were performed with unknown results. The dog was administered an unknown amount of unspecified fluids subcutaneously. The dog was started on unspecified doses of prednisone 20mg and doxycycline 100mg orally. On 06Jul2018, the dog collapsed in the rear limbs. On 07Jul2018, the dog was examined and hospitalized by the veterinarian as the dog was recumbent. The dog tested positive for Ehrlichiosis. Additional blood work was performed with unknown results. The dog had an intravenous catheter placed and was administered unspecified fluid therapy. The dog was also administered a doxycycline 100mg/ml injection. On 08Jul2018, the dog was continued on fluids, administered a dexamethasone 4mg/ml injection, then an unspecified wound he had was clipped and cleaned. On 09Jul2018, the fluids were continued and the dog was administered a metoclopramide 5mg/ml injection. The dog was tested for leptospirosis and hematocrit with unknown results. The dog died. No necropsy was performed. No further information is expected. This case is closed.

To be determined by Registrant

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


19. Provide supplemental information here

N - Unlikely Reported collapsed in the rear limbs, recumbency and unspecific wound are not typically seen with appropriate topical product administration. Signs likely associated with diagnosed Ehrlichiosis. Further, In this case, no ticks seen on dog. In case of attachment of ticks these will be killed and fall off the host within 24 to 48 hours after infestation without having had a blood meal, as a rule. However, attachment of single ticks and even sucking of blood and thus transfer of tick borne disease like Ehrlichiosis cannot be excluded while the collar is worn and simply reflects the labeled claim of efficacy that is not 100% against ticks especially when infestation pressure is high. Thus, infection with tick borne diseases despite wearing a collar can occur exceptionally and is consistent with the product's claimed efficacy. This issue is addressed in the product information. 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. Though time to onset is unknown for initial signs but long for other reported signs. Overall product relation is unlikely.