Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2019-3584

2. Registrant Information.

Registrant Reference Number: USA-BAYERBAH-2019-US0029444 (Report 571280)

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.

05-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)

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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 %

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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 06-May-2019, a 6 year old, 29.2 pound, neutered, male, Bichon Frise crossbred canine, in unknown condition, with no known concomitant medical conditions, had 1 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

Crossbred

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

6

7. Weight (provide a range if necessary )

13.245

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

• Gastrointestinal System
  • Symptom - Anorexia

• Blood
  • Symptom - Hyperphosphatemia
  • Symptom - Blood urea nitrogen increased

• General
  • Symptom - Dehydration

• Gastrointestinal System
  • Symptom - Weight loss
  • Symptom - Melena
  • Symptom - Vomiting
  • Symptom - Diarrhea

• General
  • Symptom - Lethargy

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 05Jun2019, the dog had a seizure. On 06Jun2019, the dog was inappetent and lethargic; the owner removed the collar. The dog was examined by the veterinarian; bloodwork was performed and showed an elevated phosphorus, elevated blood urea nitrogen and dehydration. The dog was administered subcutaneous fluids and started on ondansetron. On 10 Jun 2019, the dog was treated with fluids, maropitant citrate, and dexamethasone injection. Prednisone and maropitant citrate were started and the dog was started on a gastrointestinal diet. On 15 Jun 2019, the dog exhibited dark tarry stools. Fecal analysis and giardia testing were negative. Sucralfate was re-filled. On 16 Jun 2019, stools were soft but did not contain blood. Vomiting recurred. On 18 Jun 2018, stools were dark. A vitamin and mineral supplement was started and sucralfate was refilled. On 27 Jun 2019, the dog was still inappetant and lethargic, vomiting again, had soft stool, and had lost 6 pounds. The owner had been giving the dog pumpkin beginning on an unknown date. Maropitant citrate was refilled and referral to specialty clinic for further diagnostics and treatment was advised but declined by the owner. On 29 Jun 2019, the dog died. Necropsy did not reveal any gross lesions.

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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 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 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. Time to onset is not suggestive of product involvement. Other causes are more probable. Reported inappentence and lethargy are unspecific and may have numerous other causes. Signs may occur initially after collar administration but are not expected to appear after long time. Additionally reported abnormal blood reports are not expected following appropriate topical product application as inconsistent with product's pharmacological profile. Collar was already removed at that time. Further, reported dehydration is not expected, either. Later reported digestive disorders are unspecific and may have numerous other causes (e.g. gastrointestinal infection, dietary incompatibility). Severe gastrointestinal signs (e.g. reported tarry stools) are not typically seen with product use. Weight loss is not expected and likely associated with the earlier described signs. Death is not expected following appropriate topical product application as inconsistent with product's pharmacological profile. Dog likely died due to ongoing signs. Necropsy, however, did not reveal any gross lesions. But time to onset is too long. Product involvement is considered unlikely.