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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2016-0743

2. Registrant Information.

Registrant Reference Number: 2015KP371

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.

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
    • 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 01-Apr-2015, a 14 year old, approximately 15.5 pound,neutered, male, Dachshund (Miniature) canine, in good condition, with no known concomitant medical conditions,being administered an unknown heartworm preventative on the 1st of every month, had 1 Seresto Small Dog (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

Other

2. Type of animal affected

Dog / Chien

3. Breed

Miniature Dachshund

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

14

7. Weight (provide a range if necessary )

15.5

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
  • Nervous and Muscular Systems
    • Symptom - Ataxia
  • General
    • Symptom - Polydipsia
  • Gastrointestinal System
    • Symptom - Weight loss
  • Ear
    • Symptom - Hearing loss
  • Eye
    • Symptom - Other
    • Specify - Loss of vision

12. How long did the symptoms last?

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

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 an unspecified date in Sept 2015, the dog developed hind end ataxia, polydipsia, weight loss, loss of hearing and vision. On 01-Dec-2015, the dog had 1 Seresto Small Dog (Flumethrin-Imidacloprid) collar placed around the neck by the owner as the original had been worn for the labelled 8 months. On 03-Dec-2015, the dog died. No medical intervention was sought for the clinical signs and it is unknown if a 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

Ataxia is not anticipated with appropriate topical product administration. No oral product exposure reported. Even with oral product exposure only transient gastrointestinal signs but no neurological signs would be expected. Reported polydipsia, weight loss, loss of hearing and vision are not expected after topical product application as not in line with pharmaco-toxicological product profile. 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. No signs of anaphylaxis reported which would have occurred in close proximity to the collar application. Considering the known product profile and also since the collar was well tolerated for exceptionally long duration of time sufficient information exists to rule out the product involvement. Animal was geriatric which is the more likely cause for the death of an animal. Hence even though if it is unknown whether necropsy was performed, considering all aspects product relation is unlikely.