Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2020-1292

2. Registrant Information.

Registrant Reference Number: USA-BAYERBAH-2020-US0009071 (Report 624508)

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.

16-MAR-20

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)

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

Product Name: Seresto Collar unknown

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

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7. b) Type of formulation.

Other (specify)

Spot-on and Collar

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 2018, a Cockapoo canine, of unknown signalment, in unknown condition, with concomitant medical condition of having a sensitive stomach, was administered 1 tube of K9 Advantix II (unspecified) (Imidacloprid-Permethrin-Pyriproxyfen) topically by the owner. On an unspecified date in approximately 2019, the canine had 1 Seresto Dog (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

Cockerpoo

4. Number of animals affected

1

5. Sex

Unknown

6. Age (provide a range if necessary )

Unknown

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

Unknown / Inconnu

11. List all symptoms

System

• Gastrointestinal System
  • Symptom - Anorexia
  • Symptom - Other
  • Specify - unspecified gastrointestinal signs

• General
  • 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?

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 in approximately 2019, the canine exhibited anorexia and other unspecified gastrointestinal signs. It was not specified if the canine was examined. The canine died. It was unknown if a necropsy examinations was performed. No further information is expected. This case is closed.

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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 Reported anorexia and gastrointestinal signs are unspecific and may have other numerous causes. Onset time is unknown, however seems long as another product was used after treatment and before onset of signs. Death after product application is not expected in dogs, as it is inconsistent with the pharmaco-toxicological profile of the product. Reliability of the report is questionable, due to very low level of information (age, weight, medical history and time to onset unknown, necropsy not available). In fact, the intent of the phone call to Bayer was to inquire about product use in general and not to report this event and not to report the death of this dog. Other etiologies are likely. No signs of allergy/anaphylactic reaction reported. Considering all aspects, a product connection is unassessable. Seresto Collar unknown: O - Unclassifiable/unassessable Reported anorexia and gastrointestinal signs are unspecific and may have other numerous causes. Signs may occur initially after collar administration but are not expected to appear after long time. However, time to onset is unknown. Further, reported serious outcome of 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. Considering limited information regarding time to onset and animal details are unknown, a product involvement is unassessable