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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2018-2772

2. Registrant Information.

Registrant Reference Number: USA-BAYERBAH-2018-US0028376 (Report 494370)

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.

08-JUN-18

5. Location of incident.

Country: UNITED STATES

Prov / State: ALABAMA

6. Date incident was first observed.

10-MAY-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 Cat

  • 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 an unspecifie date in Feb 2018, a 14 week old, of unknown weight, intact, male, Domestic Longhair feline, in unknown condition, with no known concomitant medical conditions, had one 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

Domestic Longhair

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

0.26

7. Weight (provide a range if necessary )

Unknown

8. Route(s) of exposure

Skin

9. What was the length of exposure?

>1 mo <= 6 mos / > 1 mois < = 6 mois

10. Time between exposure and onset of symptoms

>2 mos <=6 mos / > 2 mois < = 6 mois

11. List all symptoms

System

  • General
    • Symptom - Pacing
    • Symptom - Abnormal behaviour
  • Nervous and Muscular Systems
    • Symptom - Collapse
  • Skin
    • Symptom - Cyanosis
  • General
    • Symptom - Death

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?

Yes

14. b) How long was the animal hospitalized?

8

Hour(s) / Heure(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 10-May-2018, the feline was administered an unknown anesethsia via an unknow route by the attending veterinarian for a routine neuter to be performed. Approximatly 6 hours post surgery, the feline was pacing in the kennel and hitting his head and his face on the kennel walls (behavioral). On 11May2018, the feline was gasping for breath, collapsed, turned blue and passed away 10 minutes later on the way to the emergency clinic. No necropsy was performed. No more information is exepected this case is closed.


To be determined by Registrant

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

Death

19. Provide supplemental information here

N - Unlikely Behavioural disorders such as pacing and hitting head/face are not expected with product use. Time to onset is too long as the collar was worn for approx. 2,5 months without causing adverse signs. Signs started directly after a surgery was conducted and thus were likely associated with this issue. Same applies for gasping for breath which is also not anticipated with appropriate product application. Reported collapse, cyanosis and death are also 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 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. Time to onset is long. An alternative cause is likely for this event (preceding surgery) and thus a product relation was considered as unlikely.