Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2019-2318

2. Registrant Information.

Registrant Reference Number: USA-BAYERBAH-2019-US0014213 (Report 556216)

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.

12-APR-19

5. Location of incident.

Country: UNITED STATES

Prov / State: PENNSYLVANIA

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: Advantage II (dog-unspecified)

• Active Ingredient(s)
  • IMIDACLOPRID
    • Guarantee/concentration 9.1 %
  • PYRIPROXYFEN
    • Guarantee/concentration .46 %

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PMRA Registration No.       PMRA Submission No.       EPA Registration No. Unknown

Product Name: Advantage (dog-unspecified)

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

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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).

On an unspecified date in approximately 2010, a 15 year old, approximately 60 pound, female, Chow Chow/Akita crossbred dog, of unknown reproductive status and condition, with no known concomitant medical conditions, was administered 1 tube of Advantage (dog-unspecified) (Imidacloprid) via the topical route by the animal owner.On an unspecified date post application, in approximately 2010, the dog developed arthritis.On approximately 25-Aug-2014, the dog, now 19 years old, was administered 1 tube of Advantage II (dog-unspecified) (Imidacloprid-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?

Unknown

Subform III: Domestic Animal Incident Report

1. Source of Report

Animal's Owner

2. Type of animal affected

Dog / Chien

3. Breed

Chow Chow X Akita crossbred dog

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

15

7. Weight (provide a range if necessary )

27.216

kg

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

• Nervous and Muscular Systems
  • Symptom - Other
  • Specify - Arthritis
  • Symptom - Other
  • Specify - Joint swelling

• General
  • Symptom - Death

12. How long did the symptoms last?

Persisted until death

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 post application, in approximately Sep-2014, the dog developed swollen joints. The dog was evaluated by a veterinarian and it was determined the arthritis had worsened On an unspecified date post application, in approximately Feb-2015, the dog died. No known necropsy was performed. The intent of the call was to inquire about product use in general and not to report this event. No further information expected, 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

Advantage Plus Spot-on pipette size unknown N - Unlikely Arthritis, swollen joints and death are not expected after product application, as inconsistent with pharmaco-toxicological product profile. However, arthritis was reported before product application, hence not product related. Product has wide margin of safety. The oral LD50 in rat is 642 mg/kg BW. 20-fold overdosage tolerated by dogs without showing any side effect. Time to onset is too long. Hence, other causes must be considered in this geriatric animal. Furthermore the intent of the call was to inquire about product use in general and not to report this event. Considering overall aspects, a product relation is unlikely. Advantage Spot-on pipette size unknown N - Unlikely Arthritis, later reported swollen joints and death are not expected after product application, as inconsistent with pharmaco-toxicological product profile. Product has wide margin of safety. The oral LD50 in rat is 642 mg/kg BW. 20-fold overdosage tolerated by dogs without showing any side effect. Time to onset unknown for arthritis but exceptionally long (4 years and more) for later reported swollen joints and death. Other causes must be considered in this geriatric animal. Furthermore the intent of the call was to inquire about product use in general and not to report this event. Considering overall aspects, a product relation is deemed unlikely.