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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2015-3849

2. Registrant Information.

Registrant Reference Number: 2015KP160

Registrant Name (Full Legal Name no abbreviations): Bayer Inc

Address: 2920 Matheson Boulevard

City: Missisaugua

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.

05-AUG-15

5. Location of incident.

Country: UNITED STATES

Prov / State: UNKNOWN

6. Date incident was first observed.

02-NOV-13

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 - Large Dog

  • 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 25-Jun-2013, an 8 year old, 77 pound, spayed, female, Setter (English) canine, in fair condition with a congenital liver disorder treated with an unknown daily dose of s-adenosylmethionine/silybin phosphatidylcholine complex and fed a prescription diet, had 1 Seresto Large Dog (Flumethrin-Imidacloprid) collar placed around her 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

Dog / Chien

3. Breed

English Setter

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

8

7. Weight (provide a range if necessary )

77

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

>1 mo <= 6 mos / > 1 mois < = 6 mois

10. Time between exposure and onset of symptoms

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

11. List all symptoms

System

  • General
    • Symptom - Death
  • Nervous and Muscular Systems
    • Symptom - Seizure

12. How long did the symptoms last?

<=30 min / <=30 min

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 02Nov2013 the canine had a grand mal seizure and approximately 30 minutes later died. The owner took her to a veterinarian who determined she was dead on arrival. The owner declined necropsy and the canine was cremated. Follow-up information, 2013-02-07: 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. The product is not anticipated to cause serious neurological disorders such as seizures after appropriate topical product administration. No oral product exposure reported. Even with oral product exposure, seizures and subsequent death are not expected. Onset time not suggestive of product involvement either. The collar was worn without adverse signs for at least 4 months. Other causes (e.g. idiopathic epilepsy) are more likely. Dog was in fair condition with a congenital liver disorder treated with concurrent medications that may have contributed to signs. In the end, product involvement was considered unlikely.