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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2017-0579

2. Registrant Information.

Registrant Reference Number: 2017KP082

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.

27-JAN-17

5. Location of incident.

Country: UNITED STATES

Prov / State: UNKNOWN

6. Date incident was first observed.

27-OCT-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 - Large 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 20Oct2016, a 12 year old, 23 pound, intact, male, Beagle canine, in good condition, with no known concomitant medical conditions, had 1 Seresto Large 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

Beagle

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

12

7. Weight (provide a range if necessary )

23

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

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

11. List all symptoms

System

  • General
    • Symptom - Death
  • Skin
    • Symptom - Pruritus
  • General
    • Symptom - Other
    • Specify - Penile disorder
  • Nervous and Muscular Systems
    • Symptom - Ataxia
  • Eye
    • Symptom - Blindness (permanent)
  • Gastrointestinal System
    • Symptom - Weight loss
  • Skin
    • Symptom - Irritated skin
  • Gastrointestinal System
    • Symptom - Anorexia
  • General
    • Symptom - Adipsia
    • Symptom - Lethargy

12. How long did the symptoms last?

Unknown / Inconnu

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 27Oct2016, the canine was ataxic and blind. On 03Nov2016, the canine was losing weight so the owner started feeding the canine unknown canned food and treats. On 05Nov2016, the canine developed application site pruritus and application site irritation, so the collar was removed. On 07Nov2016, the canine developed anorexia, adipsia, lethargy and had a brown discharge from his penis. The dog was not examined by a veterinarian. On 09Nov2016, the canine died. No known necropsy was performed. No more information is expected and 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. Even with oral product exposure which was not reported only transient gastrointestinal signs but no neurological signs would be expected. Time to onset is short though. Blindness and weight loss are not expected after product application as not in line with pharmacotoxicological product profile. The reported application site disorders may occur in sensitive animals after product application. They are usually mild and transient. Anorexia and lethargy are unspecific signs and may have various other causes. Brown discharge from penis is also not expected after product application. 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. Animal involved in this case was geriatric which may have contributed to blindness and death of the animal. Time to onset is long. Finally, even though some information (e.g. necropsy results) missing, considering the serious and most prominent signs death and blindness, no plausible connection can be made to the product and a product relation is deemed to be unlikely.