Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2018-3589

2. Registrant Information.

Registrant Reference Number: USA-BAYERBAH-2018-US0042287 (Report 508470)

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.

27-JUL-18

5. Location of incident.

Country: UNITED STATES

Prov / State: PENNSYLVANIA

6. Date incident was first observed.

21-AUG-17

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)

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

Product Name: Seresto Large Dog

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

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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 an unspecified date in approximately Jul 2017, a 14 year old, 16 pound, neutered, male, Maltese dog, in unknown condition, with no known concomitant medical condition, had 1 Seresto Large Dog (Flumethrin-Imidacloprid) collar placed around the neck by the animal owner. This is an off label use as this is an overdose for this dog.

To be determined by Registrant

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

No

Subform III: Domestic Animal Incident Report

1. Source of Report

Animal's Owner

2. Type of animal affected

Dog / Chien

3. Breed

Maltese

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

14

7. Weight (provide a range if necessary )

7.257

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

Unknown / Inconnu

11. List all symptoms

System

• Nervous and Muscular Systems
  • Symptom - Ataxia

• Renal System
  • Symptom - Anuria

• Gastrointestinal System
  • Symptom - Other
  • Specify - Decreased Bowel movements
  • Symptom - Weight loss

• Respiratory System
  • Symptom - Difficulty Breathing

• Eye
  • Symptom - Decreased vision

• Blood
  • Symptom - Other
  • Specify - Unspecified value on bloodwork

• General
  • Symptom - Death

• Nervous and Muscular Systems
  • Symptom - Seizure

• General
  • Symptom - Hyperactivity
  • Symptom - Lethargy

• Gastrointestinal System
  • Symptom - Anorexia

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?

Yes

14. b) How long was the animal hospitalized?

Unknown

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 approximately 21Aug2017 the dog developed a seizure NOS. On approximately 22Aug2017 the dog developed impaired vision. On an unspecified date post 21Aug2017, the dog developed hyperactivity by running around the house soon before developing a seizure (unspecified date(s) and duration of time). On approximately 23Aug2017, the dog was evaluated by a veterinarian, unspecified bloodwork had been performed and an unspecified value on the bloodwork was elevated. Clinical signs continued and on an unspecified date in approximately Sep2017 the dog was evaluated by the veterinarian. The dog was prescribed, administered and continued to be administered an unspecified dose, route and frequency of Phenobarbitol. On approximately 04Dec2017, the dog developed lethargy, anorexia, ataxia (falling over), not urinating, decreased bowel movements, weight loss, and difficulty breathing (unspecified). On 08Dec2017 the dog developed a seizure and approximately 1 minute post clinical sign onset, the dog passed away at home. No necropsy was performed. Due to the sensitive nature of communication, specific relevant event details were not obtained, nor will such be sought. No further information is expected. This case is closed.

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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 serious neurological disorders of seizures is not anticipated 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 and were requested by authorities to be content of the EU SPC. 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. 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. Impaired vision is not expected with appropriate product use as not consistent with product's pharmacological profile. Later reported digestive, behavioural and systemic disorders unspecific and may have numerous other causes. No oral product exposure reported. Additionally reported ataxia is not typically seen with appropriate topical product administration. Even with oral product exposure only transient gastrointestinal signs are expected. Furthermore 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. No signs of anaphylaxis reported which would have occurred in close proximity to the collar application. Moreover time to onset is long for all the reported signs. Even though no necropsy results are available, alternative causes should be considered in the geriatric animal. Overall, considering all aspects, a product relation is unlikely.