Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2018-0934

2. Registrant Information.

Registrant Reference Number: USA-BAYERBAH-2018-US0003125 (Report 469210)

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.

31-JAN-18

5. Location of incident.

Country: UNITED STATES

Prov / State: ILLINOIS

6. Date incident was first observed.

28-NOV-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
  • 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 24-Nov-2017, a 5 month old, 4.69 pound, intact, male, Birman feline, in unknown condition, with no known concomitant medical conditions, 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

Animal's Owner

2. Type of animal affected

Cat / Chat

3. Breed

Birman (Sacred Birman)

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

5

7. Weight (provide a range if necessary )

2.127

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

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

11. List all symptoms

System

• Gastrointestinal System
  • Symptom -
  • Specify - Inappetance

• General
  • Symptom - Pica

• Nervous and Muscular Systems
  • Symptom - Abnormal gait
  • Symptom - Difficulty walking
  • Symptom - Muscle weakness
  • Specify - Limb weakness

• General
  • Symptom - Lethargy
  • Symptom - Death

• Nervous and Muscular Systems
  • Symptom - Other
  • Specify - Congenital neurological disorder NOS

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?

5

Day(s) / Jour(s)

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 28 Nov2017, the cat was inappetent. On approximately 04Dec2017, the cat was eating litter (pica) and had other behavior changes. On 5 Dec 2017, the collar was removed from the cat. On 20 Dec 2017, the cat was weak in rear limbs when dropped off with the veterinarian for castration to be performed. The cat was anesthetised with unspecified medications and castration was performed. On an unspecified date in Dec 2017, the rear limb weakness worsened. On 27Dec2017, the cat was examined by a veterinarian for scissor step gait and was diagnosed with a luxation of the patellae. On approximately 5Jan2018, the cat was barely walking and lethargic. On an unspecified date in Jan2018, the cat was examined by another veterinarian and diagnosed with unspecified congenital disease. On approximately 20 Jan2018, the cat was hospitalized with a holistic veterinarian who monitored the cat for 5 days. On 25Jan2018 the cat was returned to the owner with better appetite and more energy (lethargy resolved). The cat died that night. No necropsy was performed. 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 Inappetence is unspecific and may have numerous other causes. Sign may occur initially after collar administration. Further reported signs pica and behavioural change are also unspecific and are not expected to appear after long time (10 days). Reported musculoskeletal disorders and neurological disorders are not expected after appropriate topical product application, especially not to start 15 days after collar removal. The cat was castrated even though weak rear limbs were reported. Later reported lethargy (1 month after collar removal) is unspecific and likely associated with other clinical signs. It is possible that the later dignosed congenital disease was responsible for the observed signs, including the death of the animal. Even oral exposure to the collar, which was not reported in this case, 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. No signs of anaphylaxis reported which would have occurred in close proximity to the collar application. Even though time to onset for initial signs is short, later reported signs occurred long time after product removal which suggests other unrelated causes, i.e. congenital disorder. Finally, even though some information (e.g. necropsy results) missing, considering diagnosis of congenital disease and timeline, no plausible connection can be made to the product and a product relation is deemed to be unlikely.