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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2019-0820

2. Registrant Information.

Registrant Reference Number: USA-BAYERBAH-2019-US0002675 (Report 544355)

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.

24-JAN-19

5. Location of incident.

Country: UNITED STATES

Prov / State: GEORGIA

6. Date incident was first observed.

Unknown

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
      • 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 15-Mar-2018, a 5.5 year old, 9 pound, neutered, female, 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

Female

6. Age (provide a range if necessary )

5.5

7. Weight (provide a range if necessary )

4.082

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

Unknown / Inconnu

11. List all symptoms

System

  • Renal System
    • Symptom - Blood in urine
    • Symptom - Renal failure
  • General
    • Symptom - Death
  • Gastrointestinal System
    • Symptom - Weight loss

12. How long did the symptoms last?

Persisted until death

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

Yes

14. a) Was the animal hospitalized?

Yes

14. b) How long was the animal hospitalized?

Unknown

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 an unknown date post application, in 2018, the feline appeared to have lost weight. On 12 Nov 2018, the feline was examined by a veterinarian, a urinalysis was performed and revealed blood in the urine. The feline was administered an unspecified dose of oral orbifloxacin. The clinical signs continued. On 26 Nov 2018, the feline was re-examined by a veterinarian, hospitalized, bloodwork was performed and the feline was diagnosed with renal failure. A feeding tube was placed and the feline discharged. The clinical signs continued. On 03 Jan 2019, the cat died. No 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 - Weight loss, blood in urine and renal failure are not expected following appropriate topical product application as inconsistent with product's pharmacological profile. Moreover, weight loss and blood in urine may be associated with later diagnosed renal failure. Further reported death is not expected either 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. This is supported by the extremely low systemic exposure with imidacloprid and flumethrin, particularly during the first week after application and also thereafter. Previous exposure was well tolerated by the animal. In this case, cat may have died due to renal failure. Though time to onset is unknown for weight loss, it is long for all other signs. Thus, other causes are more likely. In the end, considering all aspects sufficient information exists to rule out product involvement and a product relation is deemed to be unlikely.