Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2017-2206

2. Registrant Information.

Registrant Reference Number: 2017KP150

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.

19-APR-17

5. Location of incident.

Country: UNITED STATES

Prov / State: UNKNOWN

6. Date incident was first observed.

04-NOV-14

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 - Cat

• Active Ingredient(s)
  • FLUMETHRIN
  • 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 26-Oct-2014, an 11 year old, 19 pound, neutered, male,Maine Coon Cat feline, in good condition, with excessive grooming behavior, had 1 Seresto Cat (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

Other

2. Type of animal affected

Cat / Chat

3. Breed

Maine Coon

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

11

7. Weight (provide a range if necessary )

19

lbs

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

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

11. List all symptoms

System

• General
  • Symptom - Death

• Skin
  • Symptom - Lesion
  • Symptom - Hair loss
  • Symptom - Pruritus

12. How long did the symptoms last?

Persisted until death

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

No

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 04-Nov-2014, the cat developed application site bleeding lesion, application site alopecia, application site pruritus, and alopecia on his abdomen. The collar was removed. On 13-Nov-2014, the collar was reapplied. On approximately 27-Nov-2014, the collar was removed. On approximately 01-Jan-2015, the cat's application site bleeding lesion resolved without medical intervention. As of 12-Mar-2015, the cat's application site alopecia, application site pruritus, and alopecia on his belly continued. Follow up received on 17th Mar 2017: On 26-Oct-2014, an 11 year old, 19 pound, neutered, male, Maine Coon Cat feline, in good condition, with excessive grooming behavior, had 1 Seresto Cat (Flumethrin-Imidacloprid) collar placed around the neck by the owner. On 04-Nov-2014, the cat developed application site lesion, application site alopecia, application site pruritus, and alopecia on his abdomen. The collar was removed. On 13-Nov-2014, the collar was reapplied. On approximately 27-Nov-2014, the collar was removed. On approximately 01-Jan-2015, the application site lesion resolved without medical intervention; the application site alopecia, application site pruritus, and alopecia on his belly continued. On an unspecified date post removal, in 2015, the cat 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

The reported application site disorders may occur in sensitive animals after product application. They are usually mild and transient. Skin disorders on other than the application site are not typically seen with topical product administration. Though initial pruritus may be seen with collar use, other skin disorders like alopecia on the abdomen are not expected. It may be as a consequence to history of excessive grooming. Furthermore signs continued despite collar removal. Death is not expected following appropriate topical product application as inconsistent with products 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. The animal involved was geriatric in this case. Time to onset consistent for initially reported skin disorders, however seems long for later reported death. In case of suspected product involvement case would have been reported in close proximity and not long time after. No necropsy was performed. In spite of application site involvement, considering serious outcome product relation is considered as unlikely.