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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2018-2047

2. Registrant Information.

Registrant Reference Number: USA-BAYERBAH-2018-US0011722 (Report 477298)

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

Address: 2920 Matheson BLVD

City: Mississauga

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.

04-APR-18

5. Location of incident.

Country: UNITED STATES

Prov / State: UNKNOWN

6. Date incident was first observed.

26-JAN-18

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 Small 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 19-Jan-2018, a 14 year old, 12.9 pound, neutered, female, Shih Tzu canine, in unknown condition, with no known concomitant medical conditions, 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

Shih Tzu

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

14

7. Weight (provide a range if necessary )

5.851

kg

8. Route(s) of exposure

Skin

9. What was the length of exposure?

>1 mo <= 6 mos / > 1 mois < = 6 mois

10. Time between exposure and onset of symptoms

>3 days <=1 wk / >3 jours <=1 sem

11. List all symptoms

System

  • General
    • Symptom - Death
    • Symptom - Lethargy
  • Nervous and Muscular Systems
    • Symptom - Seizure
  • Respiratory System
    • Symptom - Difficulty Breathing
  • Gastrointestinal System
    • Symptom - Vomiting
  • Renal System
    • Symptom - Urine discoloration
  • General
    • Symptom - Other
    • Specify - Increased pancreatic enzymes

12. How long did the symptoms last?

>2 mos and <=6mos />2 mois et <=6mois

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

Yes

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 26 Jan 2018, the dog had very dark urine and lethargy. On approximately 15 Feb 2018, the dog was examined by a veterinarian and blood work was performed and reveled increased pancreatic enzymes. No treatments were performed. Clinical signs continued. On 30 Mar 2018, the dog began vomiting and had difficulty breathing. The dog was examined by a veterinarian and the dog was administered and unknown amount of subcutaneous fluids and was administered an unspecified antibiotic injection. On 31 Mar 2018, the dog had a seizure and died at home. No necropsy was performed. No more information is expected. This case is closed.


To be determined by Registrant

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

Death

19. Provide supplemental information here

N-Unlikely: Reported dark urine is not an expected sign with appropriate topical product application. Lethargy is unspecific and may have various other causes. Reported digestive signs are unspecific and may have numerous other causes (e.g. gastrointestinal infection, dietary incompatibility). Mild gastrointestinal signs may occur shortly after product application, but here time to onset is too long. No oral product exposure reported. Difficulty in breathing is not anticipated after product administration. 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. Even with oral product exposure, seizures are not expected. Merely gastrointestinal signs would be possible. Various etiologies exist for seizure events or paroxysmal signs, e.g. heart disorder, development disorder, metabolic disorder, infection, intoxication, idiopathic epilepsy, trauma, neoplasms. 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. No signs of anaphylaxis reported which would have occurred in close proximity to the collar application. Time to onset long. Other causes are more probable in this geriartric dog. Even though no necropsy is available, considering the known product profile sufficient information exists to conclude that the product did not cause the event and product involvement was ruled out.