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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2018-1629

2. Registrant Information.

Registrant Reference Number: USA-BAYERBAH-2018-US0010350 (Report 476139)

Registrant Name (Full Legal Name no abbreviations): Bayer inc

Address: 2920 Matheson BLVD

City: Mississauga

Prov / State: ON

Country: Canada

Postal Code: L5W5R6

3. Select the appropriate subform(s) for the incident.

Domestic Animal

4. Date registrant was first informed of the incident.

27-MAR-18

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 Large Dog

  • Active Ingredient(s)
    • FLUMETHRIN
      • Guarantee/concentration 4.5 %
    • IMIDACLOPRID
      • Guarantee/concentration 10 %

7. b) Type of formulation.

Other (specify)

COLLAR

Application Information

8. Product was applied?

Yes

9. Application Rate.

Unknown

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 unknown date in May2017, a 10 year old, 25 pound, neutered, male, Cairn Terrier canine, in unknown condition, with a concomitant medical condition of blindness, had 1 Seresto Large Dog (Flumethrin-Imidacloprid) collar placed around the neck by the owner. On an unknown date in Jan2018, the canine had the Seresto collar replaced with a new Seresto large dog collar.

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

Animal's Owner

2. Type of animal affected

Dog / Chien

3. Breed

Cairn Terrier

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

10

7. Weight (provide a range if necessary )

11.34

kg

8. Route(s) of exposure

Skin

9. What was the length of exposure?

>6 mos <=1 yr / > 6 mois < = 1 an

10. Time between exposure and onset of symptoms

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

11. List all symptoms

System

  • Gastrointestinal System
    • Symptom - Constipation
  • Renal System
    • Symptom - Urinary incontinence
  • Respiratory System
    • Symptom - Coughing
  • Renal System
    • Symptom - Other
    • Specify - renal disorder NOS
  • Gastrointestinal System
    • Symptom - Anorexia
  • General
    • Symptom - Death
  • Eye
    • Symptom - Blindness (permanent)

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 unknown date in Nov2017, the canine developed a bowel obstruction, was incontinent, developed renal disorder and had developed a cough. On 21Mar2018, the canine was anorexic. On 23Mar2018, the canine died. The canine was never examined by a veterinarian and no known necropsy was performed.


To be determined by Registrant

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

Death

19. Provide supplemental information here

N - Unlikely: Severe gastrointestinal sign e.g. Bowel obstruction is not typically seen with product use. No oral product exposure reported. Time to onset long witn 6 month. Reported incontinent, renal disorder, cough are not expected after appropriate collar application. Signs are inconsistent with pharmaco-toxicological product profile. Further reported anorexia is unspecific and may be consequence of other reported signs. Death is not expected following appropriate topical product application as inconsistent with product's 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 without causing serious signs. Death likely related to renal disorder or other underlying disease in this elderly dog already suffering from blindness. Time to onset long. Previous exposure is well tolerated, in case of suspected product involvement, product would not have been replaced. Overall, a product involvement is considered as unlikely.