Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2018-0918

2. Registrant Information.

Registrant Reference Number: USA-BAYERBAH-2018-US0000907 (Report 466785)

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.

10-JAN-18

5. Location of incident.

Country: UNITED STATES

Prov / State: NEW YORK

6. Date incident was first observed.

Unknown

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 Cat

• Active Ingredient(s)
  • FLUMETHRIN
  • 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 unknown date in Feb 2017, a 15 year old, 5 pound, neutered, female, Unknown Breed feline, in unknown condition, with no known concomitant medical conditions, had one Seresto Cat (Flumethrin-Imidacloprid) collar placed around the neck by the owner. The collar was missing the safety plastic seal on the outside of the collar.

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

Cat / Chat

3. Breed

Unknown

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

15

7. Weight (provide a range if necessary )

2.268

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

>1 wk <=1 mo / > 1 sem < = 1 mois

11. List all symptoms

System

• General
  • Symptom - Death

• Renal System
  • Symptom - Frequent urination

• Skin
  • Symptom - Other
  • Specify - Mammary lumps

• Cardiovascular System
  • Symptom - Arrhythmia

• Renal System
  • Symptom - Other
  • Specify - Renal disorder NOS

• Nervous and Muscular Systems
  • Symptom - Other
  • Specify - Unable to jump

12. How long did the symptoms last?

>6 mos / > 6 mois

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 an unknown date in Feb 2017, approximately 2 weeks post application the feline had increased urination. The feline was examined by a veterinarian. Unknown tests and treatments were performed. On an unknown date in 2017, the feline was examined by a veterinarian, then was diagnosed with mammary lumps, heart arrhythmia, and an unspecified kidney disorder. The owner then started to give an unspecified dose of Cannabidiol (CBD) oil to the feline. On an unknown date in 2017, the mammary lumps resolved. On an unknown date in approximately Sept 2017, the feline could no longer jump. On an unknown date in Oct 2017, the feline died and no necropsy was performed. Note: Previous application was well tolerated. Follow-up received on 19th Jan 2018: No further information is expected. 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 signs like increased urination, mammary lumps, heart arrhythmia, kidney disorder, inability to jump and serious sign such as death are not expected following appropriate topical product application as inconsistent with products pharmacological profile. Oral exposure to the collar is not expected to cause these 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. Anmal involved in this case was geriatric. Moreover, previous applications were well tolerated. Other causes are more probable. Considering long time to onset, a product relation is considered unlikely.