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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2019-0340

2. Registrant Information.

Registrant Reference Number: USA-BAYERBAH-2018-US0073030 (Report 540264)

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.

21-DEC-18

5. Location of incident.

Country: UNITED STATES

Prov / State: LOUISIANA

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. 11556-117

Product Name: Advantage 10

  • 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.

.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 2002, a 12 year old, approximately 11 pound, neutered, female, Poodle (Toy) canine, in unknown condition, with no known concomitant medical conditions, was administered 1 tube of Advantage 10 Topical Solution (Imidacloprid) topically by the owner. This was an extra label use (low dose) since the weight of the canine was outside the weight range specified for the dosage given.

To be determined by Registrant

12. In your opinion, was the product used according to the label instructions?

No

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

Female

6. Age (provide a range if necessary )

12

7. Weight (provide a range if necessary )

4.99

kg

8. Route(s) of exposure

Skin

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

>8 hrs <=24 hrs / > 8 h < = 24 h

11. List all symptoms

System

  • General
    • Symptom - Bad breath
  • Gastrointestinal System
    • Symptom - Other
    • Specify - pancreatitis
  • General
    • Symptom - Death

12. How long did the symptoms last?

Persisted until death

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

Unknown

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

Approximately 1 day post administration in 2002, the canine exhibited a change in the odor of her breath. Approximately 2 days post onset in 2002, the canine recovered. On an unknown date post administration in 2002, the canine got sick and was diagnosed with pancreatitis by a veterinarian. It is unknown what, if any treatments were performed. The canine died 1 week later. No known necropsy was performed. No further information is expected. This case is closed.


To be determined by Registrant

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

Death

19. Provide supplemental information here

N - Unlikely Change in odor of breath is unspecific and may have many potential causes. Sign is not expected after topical product use and oral product uptake was not witnessed. Pancreatitis and subsequent death are not expected after product application, as inconsistent with pharmaco-toxicological product profile. The oral LD50 in rat is 642 mg/kg BW. 20-fold overdosage tolerated by dogs without showing any side effect. The animal involved in this case is geriatric hence various other causes must be considered. Moreover, in case of suspected product involvement case would have been reported in close proximity and not after long time (16 years). Overall, a product involvement is considered as unlikely.