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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2018-5513

2. Registrant Information.

Registrant Reference Number: USA-BAYERBAH-2018-US0051979 (Report 518176)

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.

04-SEP-18

5. Location of incident.

Country: UNITED STATES

Prov / State: PENNSYLVANIA

6. Date incident was first observed.

01-SEP-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 approximately 04-Aug-2018, a 1 year old, 9 pound, intact, male, Domestic Longhair 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

Domestic Longhair

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

1

7. Weight (provide a range if necessary )

4.08

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

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

11. List all symptoms

System

  • General
    • Symptom - Death
    • Symptom - Lethargy
  • Gastrointestinal System
    • Symptom - Anorexia
  • Nervous and Muscular Systems
    • Symptom - Recumbent
  • Gastrointestinal System
    • Symptom - Vomiting
  • Respiratory System
    • Symptom - Apnea

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

On approximately 01-Sep-2018, the cat exhibited lethargy and anorexia. Approximately 4 hours post onset, the cat fell from a chair then exhibited recumbency, was unable to stand, vomited once, had apnea and died. 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

N - Unlikely Reported systemic signs such as lethargy and anorexia are unspecific and may have numerous other causes. Neurological signs are not typically seen with appropriate topical product administration. No oral product exposure reported. Even with oral product exposure which was not reported only transient gastrointestinal signs are expected. Vomiting is unspecific either and may have multiple other causes (e.g. gastrointestinal infection, dietary incompatibility). Reported recumbancy, apnoea and death are not expected following appropriate topical product application as inconsistent with product's pharmacological profile. 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 sign. Product has wide margin of safety. In this case cat had felt from the chair which likely contributed to the later reported signs. Time to onset is long. Even though no necropsy was performed, considering all aspects, a product relation is unlikely.