Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2019-5936

2. Registrant Information.

Registrant Reference Number: USA-BAYERBAH-2019-US0056960 (Report 600278)

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.

23-SEP-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)

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PMRA Registration No.       PMRA Submission No.       EPA Registration No. 11556-155

Product Name: Seresto collar

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

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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 %

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7. b) Type of formulation.

Liquid

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 unknown date in approximately 2018, an 11 year old, Bichon Frise canine, of unknown weight and sex, in unknown condition, with no known concomitant medical conditions, was administered 1 tube of K9 Advantix II (unspecified) (Imidacloprid-Permethrin-Pyriproxyfen) topically by the owner. Immediately post application, the canine exhibited an allergic reaction and behavioral change. The canine was examined by a veterinarian who recommended they discontinue use. The canine had 1 Seresto Dog (unspecified) (Flumethrin-Imidacloprid) collar placed around the neck by the owner. The canine's clinical signs resolved.

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

Bichon Frise

4. Number of animals affected

1

5. Sex

Unknown

6. Age (provide a range if necessary )

11

7. Weight (provide a range if necessary )

Unknown

8. Route(s) of exposure

Skin

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

<=30 min / <=30 min

11. List all symptoms

System

• General
  • Symptom - Other
  • Specify - Allergic reaction NOS
  • Symptom - Abnormal behaviour
  • Symptom - Death

12. How long did the symptoms last?

Unknown / Inconnu

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

No

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 canine exhibited an allergic reaction and behavioral change. The canine was examined by a veterinarian who recommended they discontinue use. The canine had 1 Seresto Dog (unspecified) (Flumethrin-Imidacloprid) collar placed around the neck by the owner. The canine's clinical signs resolved. On an unknown date in 2018, the canine died. No known necropsy was performed.

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To be determined by Registrant

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

Death

19. Provide supplemental information here

Advantix Plus Spot-on pipette size unknown O - Unclassifiable/unassessable Product has very low allergic potential. However, in individual cases, a hypersensitivity reaction to the product is possible in animals that are particularly sensitive (as with any substance). Time to onset is short. No other possible cause reported. Reported behavioral change may be a response to the feeling caused by the applied product and/or allergic reaction. Later reported death is not expected after product application as it is inconsistent with the pharmaco-toxicological profile of the product. Other etiologies are likely. The animal involved in this case is geriatric. No necropsy was performed. Considering all aspects, a product relation for the case remains unassessable. Seresto Collar unknown O - Unclassifiable/unassessable An allergic reaction and behavioural change were reported prior to collar administration. Hence, signs are not product related. Later reported 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. The animal involved in this case geriatric. No necropsy was performed. Time to onset is unknown. Considering the known product profile, sufficient information exists to conclude that the product did not cause the event. In the end, product involvement was considered unassessable.