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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2021-3196

2. Registrant Information.

Registrant Reference Number: USA-BAYERBAH-2021-US0019053 (Report 699960)

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-MAY-21

5. Location of incident.

Country: UNITED STATES

Prov / State: RHODE ISLAND

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. 11556-143

Product Name: K9advantixII large dog

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

7. b) Type of formulation.

Other (specify)

spot-on

Application Information

8. Product was applied?

Yes

9. Application Rate.

2.5

Units: mL

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 2012, an approximately 13 year old, 35 pound, neutered, male, Beagle dog, in unknown condition, with no known concomitant medical conditions, was administered 1 tube of K9 Advantix II Large Dog (Imidacloprid-Permethrin-Pyriproxyfen) via the topical route by the animal 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

Beagle

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

13

7. Weight (provide a range if necessary )

15.876

kg

8. Route(s) of exposure

Skin

9. What was the length of exposure?

>1 wk <=1 mo / > 1 sem < = 1 mois

10. Time between exposure and onset of symptoms

Unknown / Inconnu

11. List all symptoms

System

  • Eye
    • Symptom - Other
    • Specify - Loss of vision
  • General
    • Symptom - Death
  • Gastrointestinal System
    • Symptom -
    • Specify - Food allergy
  • Ear
    • Symptom - Hearing loss
  • General
    • Symptom - Cancer
  • Skin
    • Symptom - Hair loss
    • Symptom - Other
    • Specify - Skin and/or appendage neoplasm NOS

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?

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

On an unspecified date in approximately 2012, the dog developed bilateral localized alopecia localized to the flanks. On an unspecified date in approximately 2012, the dog was evaluated by a veterinarian and was diagnosed with an unspecified food allergy. On an unspecified date in approximately 2013, the dog developed an unspecified dermal cancer (Skin and/or appendage neoplasm NOS), was re-evaluated by a veterinarian, and was administered unspecified skin cancer treatments by the veterinarian. On an unspecified date in 2014, the dog developed hearing and vision loss. The dog was re-evaluated by a veterinarian, was diagnosed with an unspecified systemic cancer, and died. A necropsy was not performed.


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 Reported localized alopecia is not expected after topical application of the product and may have other numerous causes (e.g., food allergy). Later reported food allergy, systemic and unspecified dermal cancer, hearing and vision loss are not expected after topical application of the product in dogs, as it is inconsistent with the pharmaco-toxicological profile of the product. The active ingredients are not listed as mutagenic or carcinogenic. Other etiologies are likely. Death may be likely due to reported underlying diseases in this geriatric patient. No signs of allergy/anaphylactic reaction reported. Time to onset is inconsistent. Moreover, the intent of the call was to inquire about product use in general and not to report this event. Although no necropsy performed, product involvement is not likely, however due to limited information regarding animal's state of health and initial onset time, case is considered unassessable.