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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2020-2836

2. Registrant Information.

Registrant Reference Number: USA-BAYERBAH-2020-US0030862 (Report 646842)

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.

25-JUN-20

5. Location of incident.

Country: UNITED STATES

Prov / State: NORTH CAROLINA

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 collar (unspecified)

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

PMRA Registration No.       PMRA Submission No.       EPA Registration No. Unknown

Product Name: K9advantixII pipette size unknown

  • Active Ingredient(s)
    • IMIDACLOPRID
      • Guarantee/concentration 8.8 %
    • PERMETHRIN
      • Guarantee/concentration 44 %
    • PYRIPROXYFEN
      • Guarantee/concentration .44 %

7. b) Type of formulation.

Other (specify)

COLLAR, spot-on

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 unspecified date in approximately 2011, a 7 year old, Australian Shepherd canine, of unknown weight, sex, and condition, with no known concomitant medical conditions, was administered 1 tube of K9 Advantix II (unspecified) (Imidacloprid-Permethrin-Pyriproxyfen) topically by the owner. On unspecified dates in 2011, 2012, and 2013, the dog had the product applied monthly. On an unspecified date in 2013, the dog had 1 Seresto (Unspecified)(Flumethrin-Imidacloprid) collar placed around the neck by the owner. On an unspecified date post application, in 2013, the collar was removed. On unspecified dates in 2014, 2015, 2016 and 2017, the dog continued to wear a Seresto (Unspecified)(Flumethrin-Imidacloprid) collar yearly. On an unspecified date in 2018, the dog had 1 Seresto (Unspecified)(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?

Unknown

Subform III: Domestic Animal Incident Report

1. Source of Report

Animal's Owner

2. Type of animal affected

Dog / Chien

3. Breed

Australian Shepherd Dog

4. Number of animals affected

1

5. Sex

Unknown

6. Age (provide a range if necessary )

7

7. Weight (provide a range if necessary )

Unknown

8. Route(s) of exposure

Skin

9. What was the length of exposure?

>1 yr / > 1 an

10. Time between exposure and onset of symptoms

<=30 min / <=30 min

11. List all symptoms

System

  • General
    • Symptom - Abnormal behaviour
    • Specify - Rolling
    • Symptom - Vocalizing
    • Symptom - Neoplasia
    • Symptom - Death

12. How long did the symptoms last?

Unknown / Inconnu

13. Was medical treatment provided? Provide details in question 17.

Unknown

14. a) Was the animal hospitalized?

Unknown

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

Immediately post application, the dog exhibited rolling and whimpering. One day post application, in 2011, the rolling and whimpering resolved. On an unspecified date post application, in 2011, the dog was examined by a veterinarian and diagnosed with unspecified neoplasia. On an unspecified date post application in 2018 the neoplasia worsened and the dog died. No 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

Advantix Plus: O - Unclassifiable/unassessable Reported behavioural disorders are unspecific, however, may be a behavioural response to the feeling caused by the applied product. Time to onset is short. Later diagnosed unspecified neoplasia after product application is not expected. The active ingredients are not listed as mutagenic or carcinogenic. Other causes should be considered. Death after product application is not expected in dogs, as it is inconsistent with the pharmaco-toxicological profile of the product. Death in this case likely associated with underlying poor condition due worsening of neoplasia in geriatric status of the dog. No necropsy was performed. Though time to onset is short for initial signs, it is long for other reported signs. Considering overall aspects, a product connection is unassessable. Seresto: N - Unlikely Reported rolling, whimpering and neoplasia were reported prior to product use, ruling out product relation. Worsening of unspecified neoplasia followed by 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 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. This is supported by the extremely low systemic exposure with imidacloprid and flumethrin, particularly during the first week after application and also thereafter. Outcome in this case the result of pre-existing neoplasia combined with dog's age. A product connection is considered unlikely.