Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2019-2342

2. Registrant Information.

Registrant Reference Number: USA-BAYERBAH-2019-US0016933 (Report 558555)

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.

25-APR-19

5. Location of incident.

Country: UNITED STATES

Prov / State: TEXAS

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. 11556-122

Product Name: Advantage 100 (IPN:Advantage Spot-on 4.0 ml (400 mg Imi) Dog > 25 kg)

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

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7. b) Type of formulation.

Liquid

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 approximately 1996, a 4 year old, 100 pound, intact, male, Retriever (Labrador, Chocolate) canine, in unknown condition, with no known concomitant medical conditions, was administered 1 tube of Advantage 100 Topical Solution (Imidacloprid) 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

Labrador Retriever

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

4

7. Weight (provide a range if necessary )

45.35

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

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

11. List all symptoms

System

• Skin
  • Symptom - Dermatitis
  • Specify - Hot spot (pyotraumatic dermatitis)
  • Symptom - Pruritus
  • Symptom - Lesion

• General
  • Symptom - Death

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

Approximately 1 month post application, the dog had a hot spot at the tail base, an application site lesion, and application site pruritus. On an unknown date in approximately 1996, the dog was examined by a veterinarian and placed on unknown oral steroids, unknown oral antibiotics and an unknown topical anti itch cream. On an unknown date 2 months post application, the dog was recovered. On an unknown date in approximately 2004, the dog died at home. No know necropsy was performed.

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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

O - Unclassifiable/unassessable Hot spot is not expected after topical product application. Dermal reactions at the application site like pruritus and lesion are possible in animals that are particular sensitive. Time to onset is long though. Further reported death is inconsistent with pharmaco-toxicological product profile and experience. 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. In case of suspected product involvement, adverse event would have been reported in close proximity and not long time after (approximately 8 years). No necropsy was performed. Time to onset is too long. Other causes must be considered in this geriatric animal which was 12 years of age at the time of death. Considering all aspects, a product relation is unassessable.