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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2018-0461

2. Registrant Information.

Registrant Reference Number: USA-BAYERBAH-2017-US0077829 (Report 463771)

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.

14-DEC-17

5. Location of incident.

Country: UNITED STATES

Prov / State: UNKNOWN

6. Date incident was first observed.

28-NOV-17

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 28-Nov-2017, a 7 year old, approximately 15 pound, intact, female, Yorkshire Terrier canine, in unknown condition, with concomitant medical conditions of general malaise, anorexia, weight loss, had 1 Seresto Small Dog collar (Flumethrin-Imidacloprid) 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

Yorkshire Terrier

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

7

7. Weight (provide a range if necessary )

6.804

kg

8. Route(s) of exposure

Skin

9. What was the length of exposure?

>24 hrs <=3 days / >24 h <=3 jours

10. Time between exposure and onset of symptoms

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

11. List all symptoms

System

  • General
    • Symptom - Death
  • Skin
    • Symptom - Erythema
    • Symptom - Irritated skin
  • Nervous and Muscular Systems
    • Symptom - Lameness
  • General
    • Symptom - Licking
    • Symptom - Abnormal grooming
    • Specify - excessive grooming

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.

Yes

14. a) Was the animal hospitalized?

Yes

14. b) How long was the animal hospitalized?

1

Day(s) / Jour(s)

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

One hour post application the canine was excessively grooming, developed erythema and irritation near the inguinal area and paws. On 30-Nov-2017 the collar was removed. On 01-Dec-2017 the signs resolved. On unknown date in 2017 post collar removal the canine was limping and was seen at multiple vets where many therpies including ultrasound, bloodwork and radiographs were performed with unknown results. On 13-Dec-2017 the canine was evaluated by an emergency hospital. It is unknown if any therpies were performed. On 14-Dec-2017 the canine passed away. No necropsy was performed. No further information is expected. 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

O-Unassessable: Skin disorders on other than the application site are not typically seen with topical product administration. Though initial pruritus may be seen with collar use, other skin disorders are not expected. Excessive grooming is unspecific and may be associated with reported skin disorders. Death and limping 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 like death. An overdose of 5 collars around the neck was investigated in adult dogs for an 8 months period without causing serious signs. No signs of anaphylaxis reported which would have occurred in close proximity to the collar application. Moreover, dog had concomitant medical conditions of general malaise, anorexia, weight loss which may indicate an underlying health problem that have contributed to the serious outcome. Time to onset short for initial signs, later reported signs were observed post collar removal. Considering all aspects, a product involvement is unassessable.