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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2018-0465

2. Registrant Information.

Registrant Reference Number: USA-BAYERBAH-2017-US0078082 (Report 464150)

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.

17-DEC-17

5. Location of incident.

Country: UNITED STATES

Prov / State: CALIFORNIA

6. Date incident was first observed.

05-DEC-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)

PMRA Registration No.       PMRA Submission No.       EPA Registration No. 11556-155

Product Name: Seresto 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 05-Dec-2017, an 8 year old, 15 pound, neutered, male, Snowshoe feline, in unknown condition, with fleas, 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

Snowshoe

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

8

7. Weight (provide a range if necessary )

6.8

kg

8. Route(s) of exposure

Skin

9. What was the length of exposure?

>15 min <=2 hrs / >15 min <=2 h

10. Time between exposure and onset of symptoms

<=30 min / <=30 min

11. List all symptoms

System

  • Respiratory System
    • Symptom - Dyspnea
  • Gastrointestinal System
    • Symptom - Salivating excessively
  • Nervous and Muscular Systems
    • Symptom - Trembling
  • General
    • Symptom - Death
  • Nervous and Muscular Systems
    • Symptom - Recumbent
    • Specify - Recumbency
  • Respiratory System
    • Symptom - Difficulty Breathing
  • Nervous and Muscular Systems
    • Symptom - Muscle weakness
    • Symptom - Aggressive behaviour
    • Specify - aggression
    • Symptom - Muscle tremors
    • Specify - tremors

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

Approximately 25 minutes post application, the cat exhibited difficulty breathing, aggression, hypersalivation, muscle weakness, recumbency, tremors, was unable to rise and then death. No known 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

Aggression is unspecific and may have various other causes. Reported hypersalivation is also an unspecific sign and may have numerous other causes (e.g. gastrointestinal infection, dietary incompatibility). Neurological signs are not expected with appropriate topical product use. No oral exposure of the product reported. Other reported signs, difficulty in breathing, muscle weakness, reccumbency and further reported death are not expected after product administration as not in line with pharmaco toxicological product 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 short though. Considering the product profile, product involvement is deemed unlikely, and other causes were considered more likely, however due to limited information (regarding state of health, medical history and necropsy report), a product relation is unassessable. O - Unclassifiable/unassessable