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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2018-2046

2. Registrant Information.

Registrant Reference Number: USA-BAYERBAH-2018-US0011491 (Report 477208)

Registrant Name (Full Legal Name no abbreviations): Bayer inc

Address: 2920 Matheson Blvd

City: Mississauga

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.

03-APR-18

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)

PMRA Registration No.       PMRA Submission No.       EPA Registration No. 11556-141

Product Name: K9 AdvantixII small 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.

.4

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 unknown date in 2015, a 14 year old, 6 pound, neutered, male, Poodle (Toy) canine, in unknown condition, with no known concomitant medical conditions, was administered 1 tube of K9 Advantix II Small Dog (Imidacloprid-Permethrin-Pyriproxyfen) topically 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

Toy Poodle

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

14

7. Weight (provide a range if necessary )

2.722

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

  • General
    • Symptom - Death
  • Blood
    • Symptom - Other
    • Specify - Lymphoma
  • Eye
    • Symptom - Blindness (permanent)
  • Nervous and Muscular Systems
    • Symptom - Ataxia

12. How long did the symptoms last?

Persisted until death

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 unknown date in 2015, post application, the dog was examined by a veterinarian and diagnosed with lymphoma. On unknown dates in 2016, the dog was examined by a veterinarian and administered intravenous unspecified chemotherapy medications daily. On an unknown date in 2016, the dog exhibited blindness. On 01 Jul 2017, the dog fell and died. No known necropsy was performed. Due to the sensitive nature of the communication, specific relevant event details were not obtained, nor will such be sought. The reason for the initial communication was to discuss the expiration date of the product and not to report the death in this event. No more information is expected. This case is closed. Note: Previous exposure well tolerated.


To be determined by Registrant

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

Death

19. Provide supplemental information here

N-Unlikely: Reported lymphoma is not expected after product application, as inconsistent with pharmaco-toxicological product profile. Previous exposure well tolerated. Onset time not clarified, however other causes are likely in this geriatric dog. Later reported blindness, falling down and death are unexpected, other causes are likely (e.g. cataract, lymphoma, old age). For these signs, long onset time. Time for reporting is long, as intent of the phone call to Bayer was to discuss the expiration date of the product and not to report the death in this event. Considering known product safety profile, a product connection is deemed to be unlikely.