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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2016-4225

2. Registrant Information.

Registrant Reference Number: 2016KP129

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-JUL-16

5. Location of incident.

Country: UNITED STATES

Prov / State: UNKNOWN

6. Date incident was first observed.

09-APR-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 - 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 08Apr2016, a 5 year old, 196 pound, intact, male, Great Dane canine, in good condition, with no known concomitant medical conditions, had 1 Seresto Large Dog (Flumethrin-Imidacloprid) collar 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

Dog / Chien

3. Breed

Great Dane

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

5

7. Weight (provide a range if necessary )

196

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
  • Gastrointestinal System
    • Symptom - Vomiting
  • Respiratory System
    • Symptom - Panting
  • Gastrointestinal System
    • Symptom - Anorexia
  • General
    • Symptom - Abnormal behaviour
    • Specify - Behavioural Disorder

12. How long did the symptoms last?

>8 hrs <=24 hrs / > 8 h < = 24 h

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 09Apr2016, approximately 30 hours post application, the dog began to vomit and pant, so the Seresto collar was removed and he was bathed in detergent dish soap. He was not examined or treated by a veterinarian and approximately 1 hour post collar removal, the panting resolved. On 10Apr2016, the dog died. No necropsy was performed. No further information expected. Case closed. Follow up received on 18th Apr 2016: On 09Apr2016, approximately 30 hours post application, the dog began to vomit and pant and had a abnormal facial expression, so the Seresto collar was removed and he was bathed in detergent dish soap.


To be determined by Registrant

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

Death

19. Provide supplemental information here

Vomiting is unspecific and may have numerous other causes (e.g. gastrointestinal infection, dietary incompatibility). No oral product exposure reported. Further, panting and abnormal facial expression may be consequences of vomiting. Later 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 dogs for an 8 months period 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. Additionally, death is reported after removal of collar and subsequently dog was bathed with detergent dish soap. Considering the product profile, product involvement is deemed rather unlikely, however due to limited information (No alternative cause of death, no necropsy) and short time to onset, product relation is deemed to be unassessable.