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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2019-3585

2. Registrant Information.

Registrant Reference Number: USA-BAYERBAH-2019-US0029572 (Report 571325)

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.

10-JUN-19

5. Location of incident.

Country: UNITED STATES

Prov / State: MASSACHUSETTS

6. Date incident was first observed.

06-JUN-19

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 collar 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 06-May-2019, a 10 year old, 29 pound, neutered, male, Bichon Frise crossbred canine, in unknown condition, with no known concomitant medical conditions, had one Seresto Large Dog collar (Flumethrin-Imidacloprid) 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

Medical Professional

2. Type of animal affected

Dog / Chien

3. Breed

Bichon Frise crossbred

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

10

7. Weight (provide a range if necessary )

13.154

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

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

11. List all symptoms

System

  • General
    • Symptom - Death
  • Nervous and Muscular Systems
    • Symptom - Seizure
  • Blood
    • Symptom - Hyperphosphatemia
  • General
    • Symptom - Lethargy
  • Respiratory System
    • Symptom - Coughing
  • Gastrointestinal System
    • Symptom - Vomiting
    • Symptom - Bloody diarrhea
  • Blood
    • Symptom - Hyperglycemia
  • Cardiovascular System
    • Symptom - Other
    • Specify - Necropsy Term - hypertrophic ventricles (cardiac disorder NOS)

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 06Jun2019, the dog had a seizure; the owner removed the collar. The dog was examined by the veterinarian and exhibited vomiting and bloody diarrhea. Bloodwork was performed and revealed an elevated phosphorus and elevated blood glucose at 573 mg/dl. The dog was started on ondansetron. On 07Jun2019, the vomiting and diarrhea resolved. On 08Jun2019, the dog had a seizure and died. The veterinarian performed an in house necropsy and the only finding was hypertrophic ventricles. The cause of death remains unknown. On 07Jun2019, the dog exhibited lethargy in the morning. Vomiting and diarrhea resolved. On 08Jun2019, the dog had a seizure, an episode of coughing, and died. The veterinarian performed an in house necropsy and the only finding was hypertrophic ventricles (cardiac disorder NOS). The cause of death remains unknown.


To be determined by Registrant

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

Death

19. Provide supplemental information here

N - Unlikely - The product is not anticipated to cause serious neurological disorders such as seizures after appropriate topical product administration as the controlled release mechanism assures release of only low doses of active ingredient at a time. But seizures/convulsions were reported in connection with product use in dogs. However, it is known that overdose of 5 collars around the neck of adult dogs for an 8 months period and in 7 week old puppies for a 6 months period did not cause 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. Even with oral product exposure, seizures are not seen. Merely gastrointestinal signs may occur. Any action or treatment may trigger seizures in an animal with a respective disposition. Various etiologies exist for seizure events or paroxysmal signs, e.g. heart disorder, development disorder, metabolic disorder, infection, intoxication, idiopathic epilepsy, trauma, neoplasms. Reported digestive disorders are unspecific and may have numerous other causes (e.g. gastrointestinal infection, dietary incompatibility). Though mild gastrointestinal signs may occur shortly after product application, other more severe gastrointestinal signs (e.g. bloody diarrhea, hematemesis) are not typically seen with product use. No oral product exposure reported. Lethargy likely associated with other clinical signs. Reported hyperphosphatemia, hyperglycemia, coughing, cardiac disorder and later reported death are not expected after appropriate topical product application as inconsistent with product's pharmaco toxicological profile. This geriatric animal may have died due to underlying cardiac disorder. Time to onset is not suggestive of product relation. Overall, a product involvement is considered unlikely.