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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2016-7956

2. Registrant Information.

Registrant Reference Number: 2016KP237

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.

18-OCT-16

5. Location of incident.

Country: UNITED STATES

Prov / State: UNKNOWN

6. Date incident was first observed.

22-JUN-16

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 an unspecified date Mar2016, a 6 month old, 3 pound,intact, female, Havanese canine, in good condition, with fleas,had 1 Seresto Small Dog Collar (Flumethrin-Imidacloprid) 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

Other

2. Type of animal affected

Dog / Chien

3. Breed

Havaneser

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

0.5

7. Weight (provide a range if necessary )

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

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

11. List all symptoms

System

  • General
    • Symptom - Death
  • Nervous and Muscular Systems
    • Symptom - Recumbent
  • General
    • Symptom - Lethargy
    • Symptom - Dehydration
  • Cardiovascular System
    • Symptom - Heart murmur
  • Nervous and Muscular Systems
    • Symptom - Collapse
  • General
    • Symptom - Other
    • Specify - Abnormal Test Result

12. How long did the symptoms last?

>3 days <=1 wk / >3 jours <=1 sem

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?

2

Day(s) / Jour(s)

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 22Jun2016, the dog collapsed and was in lateral recumbency. The dog was administered an unspecified dose of corn syrup orally by the owner and the clinical signs resolved within approximately 2 hours. On 23Jun2016, the dog developed lethargy. On 24Jun2016, the dog was examined by a veterinarian. It is unknown if any treatments were performed. On 25Jun2016, the dog was examined by an emergency veterinarian and diagnosed with dehydration, a hear murmur, and tapeworms. The dog was hospitalized and administered an unknown dose of intravenous fluids. On 27Jun2016, the dog died. No necropsy was performed. The intent of the initial phone call was to discuss use of a different Bayer product and not to report the death of the patient. 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

Reported collapse and lateral recumbency are not expected after topical product application as signs inconsistent with pharmaco-toxicological product profile. Further lethargy is an unspecific sign and may have numerous other causes. Later diagnosed dehydration, heart murmur and tapeworms are not expected either. 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. No signs of anaphylaxis reported which would have occurred in close proximity to the collar application. Time to onset is long. The owner did not believe in product involvement either as the reason for initial call was to discuss use of a different Bayer product and not to report the death of the patient. Other causes are more likely, e.g. heart disease. Although no necropsy performed, considering the known product profile sufficient information exists to conclude that the product did not cause the event and product involvement is unlikely.