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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2016-0739

2. Registrant Information.

Registrant Reference Number: 2015KP367

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.

11-NOV-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 14Oct2015, a 7 year old, 2.3 pound, neutered, male,Domestic Shorthair feline, in fair condition, with an active flea infestation and anemia, had 1 Seresto Cat collar (Flumethrin-Imidacloprid) placed around his 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

Domestic Shorthair

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

7

7. Weight (provide a range if necessary )

2.3

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

>24 hrs <=3 days / >24 h <=3 jours

11. List all symptoms

System

  • General
    • Symptom - Death
  • Blood
    • Symptom - Anemia

12. How long did the symptoms last?

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

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

Yes

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

11Nov2015, the cat was evaluated by the veterinarian to recheck the anemia. The anemia had resolved but the cat had developed an application site ulcer. The collar was removed and the effected area was cleaned. 23Nov2015, the cat passed away. No necropsy was performed. No more information expected. Case closed.


To be determined by Registrant

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

Death

19. Provide supplemental information here

Transient mild application site disorder may occur in particularly sensitive animals shortly after product application. Sign is consistent with pharmaco- oxicological product profile. However, it is unknown if correct fit of collar was checked periodically as recommended in the product information. 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 death 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. Moreover death occurred long time after collar removal. A relation with the prior application site reaction was not evident. Considering the known product profile and long time to onset, sufficient information exists to conclude that the product did not cause the death. Considering all aspects, a product connection is unlikely.