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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2017-6443

2. Registrant Information.

Registrant Reference Number: USA-BAYERBAH-2017-US0051924

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.

11-AUG-17

5. Location of incident.

Country: UNITED STATES

Prov / State: PENNSYLVANIA

6. Date incident was first observed.

01-JAN-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).

An 8 year old, 28 pound, neutered, male, Domestic Shorthair cat, in unknown condition, with a concomitant medical condition of obesity, had 1 Seresto Cat collar placed around the neck by the animal 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 Shorthair

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

8

7. Weight (provide a range if necessary )

12.701

kg

8. Route(s) of exposure

Skin

9. What was the length of exposure?

>6 mos <=1 yr / > 6 mois < = 1 an

10. Time between exposure and onset of symptoms

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

11. List all symptoms

System

  • General
    • Symptom - Polydipsia
  • Renal System
    • Symptom - Urinary incontinence
  • General
    • Symptom - Death

12. How long did the symptoms last?

Unknown / Inconnu

13. Was medical treatment provided? Provide details in question 17.

Unknown

14. a) Was the animal hospitalized?

Unknown

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 30-Sep-2016, an 8 year old, 28 pound, neutered, male, Domestic Shorthair cat, in unknown condition, with a concomitant medical condition of obesity, had 1 Seresto Cat (Flumethrin-Imidacloprid) collar placed around the neck by the animal owner. On approximately 01-Jan-2017, the cat exhibited increased drinking and increased urination. The cat was examined by the veterinarian who performed unspecified blood work; results are unknown. On an unspecified date in Jun-2017, the collar was removed and a the cat had 1 new Seresto Cat (Flumethrin-Imidacloprid) collar placed around the neck by the animal owner. On approximately, 28-Jul-2017, the cat died. No known necropsy was performed. No further information is expected. 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 Polydipsia and polyuria is unspecific and may have numerous other causes (e.g. renal disease). Further reported death is not expected following appropriate topical product application as inconsistent with products 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. Collar was well tolerated for long duration without any adverse event. Time to onset is long. OTher causes are more likely (e.g. underlying disease in this old cat). Even though some information is not available (e.g. necropsy report), a relation to the product is unlikely.