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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2016-2759

2. Registrant Information.

Registrant Reference Number: 2016KP077

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.

04-MAY-16

5. Location of incident.

Country: UNITED STATES

Prov / State: UNKNOWN

6. Date incident was first observed.

16-MAR-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 - Small 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 16-Mar-2016, a 8 year old, 12 pound, neutered, female,Cairn Terrier crossbred canine, in good condition, with congestive heart failure, who was treated with unknown medications since approximately 2014, had one SerestoSmall 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

Cairn Terrier Crossbreed

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

8

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
  • General
    • Symptom - Lethargy
  • Gastrointestinal System
    • Symptom - Anorexia
    • Symptom - Diarrhea
  • Nervous and Muscular Systems
    • Symptom - Convulsions
    • Symptom - Seizure
    • Symptom - Collapse
  • Liver
    • Symptom - Other
    • Specify - Hepatopathy
  • General
    • Symptom - Cancer

12. How long did the symptoms last?

Unknown / Inconnu

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

Immediately post application the dog exhibited lethargy, anorexia, and diarrhea. On 17-Mar-2016 the dog exhibited ataxia and had a seizure. The collar was removed. No treatments or diagnostics were performed. The clinical signs continued. On 18Mar2016 the dog presented to the veterinarian and collapsed and died. A gross necropsy was performed at the clinic, the findings were liver disease and neoplasia through out the dog. Note: Previous exposure was well tolerated. Follow up received on 17th March 2016: On 16-Mar-2016, a 8 year old, 12 pound, neutered, female, Cairn Terrier crossbred canine, in fair condition, with congestive heart failure, who was treated with unknown medications since approximately 2014, had one Seresto Small Dog (Flumethrin-Imidacloprid) collar placed around the neck by the owner.


To be determined by Registrant

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

Death

19. Provide supplemental information here

Diarrhea is unspecific and may have numerous other causes (e.g. gastrointestinal infection, dietary incompatibility). Lethargy and anorexia may be consequence of reported diarrhea. The product is not anticipated to cause serious neurological disorders such as seizure after appropriate topical product administration as the controlled release mechanism assures release of only low doses of active ingredient at a time. Overdose of 5 collars around the neck of 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 did not cause serious sign either. Even with oral product exposure, seizure would not be expected. Merely gastrointestinal signs would be possible. Any action or treatment may trigger seizures in an animal with a respective disposition. Ataxia may be consequence of reported seizure. Death, collapse, liver disease and neoplasia are signs 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. No signs of anaphylaxis reported which would have occurred in close proximity to the collar application. Death was the consequence of concomitant condition of congestive heart failure and later diagnosed liver disease and neoplasia as per the necropsy performed. Moreover the animal reported was in a fair condition which may also be a contributing factor to the death of an animal. Death and collapse occurred after collar removal hence not product related. Though time to onset is short for initial signs however considering the serious outcome as death, the known product profile and previous application of collar well tolerated by an animal, a product connection is deemed to be unlikely.