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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2016-0749

2. Registrant Information.

Registrant Reference Number: 2015KP377

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.

08-DEC-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 an unspecified date in approximately Oct-2015, a 17 year old, approximately 12 pound, neutered, female, Pomeranian canine, in fair condition, with fleas and arthritis, was administered 1 tube of K9 Advantix II (unspecified)(Imidacloprid-Permethrin-Pyriproxyfen) topically by the owner.On 07-Dec-2015, the dog 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

Pomeranian

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

17

7. Weight (provide a range if necessary )

12

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
  • Renal System
    • Symptom - Frequent urination
    • Symptom - Urinary incontinence

12. How long did the symptoms last?

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

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

On approximately 08Dec2015 the dog exhibited ataxia, frequent urination and incontinence. On approximately 09Dec2015, the owner removed the collar. On approximately 10Dec2015, the dog was taken to the veterinarian for exam; it was unknown if treatments were started. On 11Dec2015, the dog died at home. No 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

Death is not expected following appropriate topical product application as inconsistent with products pharmacological profile. No oral exposure or overdose suspected. No signs of anaphylaxis reported which would have occurred in close proximity to the collar application. Neurologic and renal disorders preceded the death, evoking neurological condition. Neurological signs are not anticipated with appropriate topical product administration. Time to onset is short, though. Other causes have to be considered (e.g. geriatric condition). As necropsy has not been performed, final clarification is not possible. Considering the product profile, product involvement is deemed rather unlikely, however due to limited information, case remains unassessable.