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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2020-5440

2. Registrant Information.

Registrant Reference Number: USA-BAYERBAH-2020-US0045541 (Report 662669)

Registrant Name (Full Legal Name no abbreviations): Elanco

Address: 150 Research Lane, Suite 120

City: Guelph

Prov / State: ON

Country: Canada

Postal Code: N1G 4T2

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

Domestic Animal

4. Date registrant was first informed of the incident.

02-SEP-20

5. Location of incident.

Country: UNITED STATES

Prov / State: KANSAS

6. Date incident was first observed.

29-AUG-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)

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

Product Name: Seresto collar Large

  • 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 28Aug2020, a 5 month old, 67.9 pound, intact, male, Mastiff canine, in unknown condition, with a concomitant medical condition of muscle stiffness, was bathed with an unspecified shampoo and an all natural topical oil for fleas was applied, and had 1 Seresto Large Dog collar (Flumethrin-Imidacloprid) placed around his 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

Mastiff

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

0.41

7. Weight (provide a range if necessary )

30.799

kg

8. Route(s) of exposure

Skin

9. What was the length of exposure?

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

10. Time between exposure and onset of symptoms

>8 hrs <=24 hrs / > 8 h < = 24 h

11. List all symptoms

System

  • General
    • Symptom - Death
  • Respiratory System
    • Symptom - Respiratory distress
  • Blood
    • Symptom - Other
    • Specify - Elevated alanine aminotransferase (ALT)
    • Symptom - Leukocytosis
    • Symptom - Other
    • Specify - Elevated creatine-kinase (CK)
    • Symptom - Other
    • Specify - Increased urine concentration
  • Nervous and Muscular Systems
    • Symptom - Muscle pain
  • General
    • Symptom - Hesitancy to move
  • Renal System
    • Symptom - Blood in urine
  • Nervous and Muscular Systems
    • Symptom - Stiffness
  • General
    • Symptom - Lethargy
  • Nervous and Muscular Systems
    • Symptom - Recumbent
  • General
    • Symptom - Fever
  • Renal System
    • Symptom - Other
    • Specify - Urine abnormalities NOS
    • Symptom - Other
    • Specify - Myoglobinuria
  • Nervous and Muscular Systems
    • Symptom - Other
    • Specify - Myositis
  • Blood
    • Symptom - Other
    • Specify - Elevated blood urea nitrogen

12. How long did the symptoms last?

Persisted until death

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 29Aug2020, the concomitant stiffness worsened and the dog was lethargic. The dog was administered 0.5 tablet of naproxen sodium by the owner. On 30Aug2020, the dog refused to walk and had limb pain during palpation. The dog was administered two unspecified doses of acetylsalicylic by the owner. On 31Aug2020, the dog was evaluated by a veterinarian, was laterally recumbent and had a fever of 104. Bloodwork performed revealed elevated white blood cells (27,000), elevated alanine transaminase (4495), elevated Creatine phosphokinase (143452), elevated urine specific gravity (1068), and elevated blood urea nitrogen (30). Thoracic radiographs performed were within normal limits. A urinary catheter was placed and the dog's urine was extremely dark, had occult bilirubin and blood. The dog was diagnosed with myoglobinuria and myositis of unknown origin. The dog went in to respiratory distress and was taken home against medical advise. On 01Sep2020, the dog died. No necropsy was performed.


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 Worsening of concomitant muscle stiffness is not expected following appropriate topical product application. Lethargy, refused to walk and limb pain on palpation, lateral recumbency are likely associated with muscle stiffness and later diagnosed myositis. Fever is unspecific and likely associated with musculoskeletal disorders and elevated white blood cells. Furthermore, abnormal blood and urine parameters, diagnosed myoglobinuria, myositis, respiratory distress and death are 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 sign 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. No sign of anaphylaxis reported which would have occurred in close proximity to the collar application. Animal may have died due to earlier described signs. No necropsy performed. Although time to onset is short, other unrelated causes must be consider. Overall, a product relation for the is unassessable.