Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2018-2767

2. Registrant Information.

Registrant Reference Number: USA-BAYERBAH-2018-US0027632 (Report 493128)

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.

06-JUN-18

5. Location of incident.

Country: UNITED STATES

Prov / State: GEORGIA

6. Date incident was first observed.

06-FEB-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 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 approximately 01-Mar-2017, a 8 year old, 58 pound, neutered, female, Crossbred Canine, in unknown condition, with no known concomitant medical conditions, had 1 Seresto Large 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

Crossbred (Dog)

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

8

7. Weight (provide a range if necessary )

26.308

kg

8. Route(s) of exposure

Skin

9. What was the length of exposure?

>6 mos <=1 yr / > 6 mois < = 1 an

10. Time between exposure and onset of symptoms

>6 mos / > 6 mois

11. List all symptoms

System

• Nervous and Muscular Systems
  • Symptom - Other
  • Specify - Dullness

• Eye
  • Symptom - Other
  • Specify - Eye disorder NOS
  • Symptom - Blindness (permanent)

• General
  • Symptom - Death
  • Symptom - Neoplasia

12. How long did the symptoms last?

Persisted until death

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

Unknown

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 approximately 06-Feb-2018, the dog was obtunded and had an unspecified eye change. The dog was examined by a veterinarian and determined to have total vision loss and lymphoma. It is unknown what diagnostics or treatments were performed. On 20-Mar-2018, the dog died due to continued illness. No necropsy was performed. Due to the sensitive nature of the communication, specific relevant event details were not obtained, nor will such be sought. The reason for the initial call was to discuss the use of Seresto in the owner's current dog and not to report the death of the patient. No further information is expected. This case is closed. Follow up received on 06 Jun 2018: On approximately 06-Feb-2018, the dog was obtunded and had an unspecified eye change. The dog was examined by a veterinarian and determined to have total vision loss and lymphoma. It is unknown what diagnostics or treatments were performed. At that point the collar had been worn for 11 months, which is an extra label use.

---

To be determined by Registrant

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

Death

19. Provide supplemental information here

N - Unlikely Off label use of the product as product was used for more than 8 months. Reported obtunded state not typically seen with appropriate topical product administration. No oral product exposure reported. Even with oral product exposure which was not reported only transient gastrointestinal signs are expected. Further reported unspecific eye change followed by loss of vision, lymphoma and subsequently reported 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 signs either. An overdose of 5 collars around the neck was investigated in adult dogs for an 8 months period without causing serious signs. No signs of anaphylaxis reported which would have occurred in close proximity to the collar application. Other unrelated causes along with underlying clinical sign e.g. lymphoma must be consider in this case. Time to onset is not suggestive of product relation. Moreover, the reason for the initial phone call was to discuss the use of product in the owner's current dog and not to report the death of the patient. Even though no necropsy is available, considering available information a product relation is unlikely.