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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2019-6456

2. Registrant Information.

Registrant Reference Number: USA-BAYERBAH-2019-US0061244 (Report 604188)

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.

10-OCT-19

5. Location of incident.

Country: UNITED STATES

Prov / State: PENNSYLVANIA

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.

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 an unspecified date in approximately 2018, an 11 year old, 100 pound, neutered, male, Retriever (Labrador, Black) crossbred canine, in unknown condition, with concomitant medical conditions of arthritis, 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

Animal's Owner

2. Type of animal affected

Dog / Chien

3. Breed

crossbred (Retriever (Labrador, Black)

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

11

7. Weight (provide a range if necessary )

45.359

kg

8. Route(s) of exposure

Skin

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

Unknown / Inconnu

11. List all symptoms

System

  • Skin
    • Symptom - Hair loss
  • General
    • Symptom - Death

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

On an unspecified date post application, in approximately Aug2018, the dog exhibited generalized alopecia. The dog was not examined by the veterinarian but was started on prednisone; the collar was removed. On an unspecified date in approximately Sep2019, the dog died at home. No necropsy was performed. The reporting party did not call to report the death of this animal but to inquire about product use on another animal. 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 - Unclassifiable/unassessable Generalized alopecia on other than the application site is not typically seen with topical product administration. Though initial pruritus may be seen with collar use, other skin disorders are not expected. Other causes (e.g. allergies) are more probable although not described. Time to onset is unknown. Reported death is not expected following appropriate topical product application as inconsistent with product's pharmacological profile. However in this case sign occurred long time after collar removal. Other unrelated causes must be considered. Further, intent of call is not to report the death of this geriatric animal but to inquire about product use on another animal. Time to onset is long. Considering overall aspects, a product relation is unassessable.