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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2017-7492

2. Registrant Information.

Registrant Reference Number: USA-BAYERBAH-2017-US0068781 (Report 454888)

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

Address: 2920 Matheson BLVD

City: Mississaugua

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.

20-OCT-17

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 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 05-Sep-2017, a 7 year old, 7 pound, neutered, female, Chihuahua/Yorkshire Terrier crossbred canine, in good condition, with no known concomitant medical conditions, 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

Animal's Owner

2. Type of animal affected

Dog / Chien

3. Breed

Chihuahua X Yorkshire Terrier crossbred

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

7

7. Weight (provide a range if necessary )

3.175

kg

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

>1 wk <=1 mo / > 1 sem < = 1 mois

11. List all symptoms

System

  • General
    • Symptom - Death
  • Gastrointestinal System
    • Symptom - Diarrhea
    • Symptom - Vomiting
  • General
    • Symptom - Lethargy
  • Gastrointestinal System
    • Symptom - Anorexia
  • Blood
    • Symptom - Hypoglycemia
  • Renal System
    • Symptom - Renal failure
  • Skin
    • Symptom - Irritated skin
  • Gastrointestinal System
    • Symptom - Weight loss
  • General
    • Symptom - Swelling

12. How long did the symptoms last?

>1 wk <=1 mo / > 1 sem < = 1 mois

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 unspecified date post application, in Sep 2017, the canine began loosing weight. On 19 Sep 2017, the canine developed application site irritation. The collar was removed and the application site irritation resolved. On 21 Sep 2017, the collar was reapplied. On 22 Sep 2017, the canine developed application site swelling. On 23 Sep 2017, the canine was lethargic and developed anorexia, vomiting, diarrhea, and hypoglycemia. The dog was taken to a veterinary clinic where blood work was performed and revealed renal failure. The dog died. No necropsy was performed. No further information expected. 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

O-Unassessable: Reported weight loss is not expected following appropriate topical product application as inconsistent with products pharmacological profile. Transient mild application site irritation may occur in sensitive animal after product application but the described application site swelling is not typically seen with product use. Scratching/self-trauma may have contributed to sign. Reported digestive disorders are unspecific and may have numerous other causes (e.g. gastrointestinal infection, dietary incompatibility). Reported lethargy and anorexia are unspecific and may be associated with reported digestive disorders. Hypoglycemia may be consequences of reported anorexia. Reported renal failure and death are 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. However, renal failure which was revealed by blood work may have contributed to the serious sign (death). Though time to onset is consistent for application site disorders, it is long for other reported signs. Other causes must be considered. No necropsy was performed. Considering known product safety profile and unexpected serious outcome, a product relation is unassessable.