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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2017-6509

2. Registrant Information.

Registrant Reference Number: USA-BAYERBAH-2017-US0048667

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.

01-AUG-17

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. Unknown

Product Name: Advantage pipette size unknown

  • Active Ingredient(s)
    • IMIDACLOPRID
      • Guarantee/concentration 9.1 %

7. b) Type of formulation.

Other (specify)

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).

An approximately 14 year old, male, Cocker Spaniel canine, of an unknown weight, reproductive status, and condition, with no known concomitant medical conditions, was administered 1 tube of Advantage (unspecified) topically 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

English Cocker Spaniel

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

14

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

>2 hrs <=8 hrs / > 2 h < = 8 h

11. List all symptoms

System

  • Nervous and Muscular Systems
    • Symptom - Collapse
  • Renal System
    • Symptom - Inappropriate urination
  • General
    • Symptom - Death
  • Renal System
    • Symptom - Other
    • Specify - Abnormal urine odour

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?

Other / Autre

specify Unknown

17. Provide any additional details about the incident

(eg. description of the frequency and severity of the symptoms

In approximately 2010, an approximately 14 year old, male, Cocker Spaniel canine, of an unknown weight, reproductive status, and condition, with no known concomitant medical conditions, was administered 1 tube of Advantage (unspecified) (Imidacloprid) topically by the owner. Approximately 6 hours post application, the dog was found collapsed and had urinated. The urine had a chemical odor. The dog was taken to a veterinarian, where he was treated with an unknown injection and bathed twice. On an unspecified date post application, in 2011, the dog died. No known necropsy was performed. No further information is expected. Case is closed. Note: The intent of the call was to discuss product use on another pet and not to report the death of the dog.


To be determined by Registrant

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

Death

19. Provide supplemental information here

N - Unlikely Collapse is not expected to occur with topical product application as inconsistent with product pharmaco-toxicological profile. No oral exposure reported. Inappropriate urination may be associated with the collapse. Chemical odor of the urine is not expected too and may have multiple other causes (e.g. diet). It must be considered that odor is subjective to the concerned individual. Time to onset is short. Further, reported death is not expected after product application, as inconsistent with pharmaco-toxicological product profile. Other unrelated etiologies are more probable. Product has wide margin of safety. In case of suspected product involvement, adverse event would have been reported in close proximity and not long time after (6 years). Moreover, the intent of the phone call was to discuss product use on another pet and not to report the death of this geriatric dog. Overall, even though some details are missing (e.g. necropsy, time to onset for death), considering fatal outcome and known safety profile of the product, product connection is ruled out.