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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2016-0741

2. Registrant Information.

Registrant Reference Number: 2015KP369

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.

15-JAN-16

5. Location of incident.

Country: UNITED STATES

Prov / State: UNKNOWN

6. Date incident was first observed.

10-DEC-15

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

  • 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 04-Dec-2015, a 10 year old, 12 pound, neutered, female,unknown breed feline, in good condition with fleas, had 1Seresto 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

Unknown

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

10

7. Weight (provide a range if necessary )

12

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
    • Symptom - Hypothermia
    • Symptom - Lethargy
  • Gastrointestinal System
    • Symptom - Vomiting
  • Nervous and Muscular Systems
    • Symptom - Unconsciousness
  • Gastrointestinal System
    • Symptom - Salivating excessively
  • Respiratory System
    • Symptom - Dyspnea
  • General
    • Symptom - Vocalizing
  • Nervous and Muscular Systems
    • Symptom - Convulsions
    • Symptom - Seizure
  • Respiratory System
    • Symptom - Difficulty Breathing

12. How long did the symptoms last?

>2 hrs <=8 hrs / > 2 h < = 8 h

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 10-Dec-2015, the cat was cold to the touch, lethargic, vomited once, her eyes were rolling back, her mouth was wet, she was having difficulty breathing, and vocalizing. The owner put the cat in the car, where it had a seizure and died approximately 4 hours post onset of signs. A necropsy was not performed on the cat.


To be determined by Registrant

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

Death

19. Provide supplemental information here

Reported systemic and behavioural signs along with respiratory signs are unspecific and may have numerous other causes. Further reported digestive disorders are also unspecific and may have numerous other causes (e.g. gastrointestinal infection, dietary incompatibility). The product is not anticipated to cause serious neurological disorders such as seizures after appropriate topical product administration as the controlled release mechanism assures release of only low doses of active ingredient at a time. Even with oral product exposure, seizures are not expected. Merely gastrointestinal signs would be possible. Other causes are more probable (e.g. idiopathic epilepsy). Death is not expected following appropriate topical product application as inconsistent with products pharmacological profile. Overdose of 5 collars around the neck of 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 did not cause serious signs either. Time to onset not suggestive of product involvement either. Even though no necropsy was performed, considering known product profile and long time to onset, a product involvement was deemed to be unlikely.