Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2015-2048

2. Registrant Information.

Registrant Reference Number: 2015KP005

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

Address: 2920 Matheson Blvd. East

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.

17-APR-14

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)

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

Product Name: Advantage (unknown size)

• Active Ingredient(s)
  • IMIDACLOPRID
    • Unknown

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7. b) Type of formulation.

Liquid

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 unknown date in approximately 2014, an 11 year old, neutered, male, Unknown Breed (Feline), of unknown weight, in good condition, was administered 1 tube of Advantage 18 Topical Solution (Imidacloprid) topically by the owner.On an unknown date in approximately 2014, the cat was administered 1 tube of Advantage Multi (18) (imidiclopridmoxidectin) topically by the owner.On an unknown date in approximately 2014, the cat was administered an unknown dose of nitenpyram orally.On approximately 04-Dec-2014, the cat was administered 1 tube of Advantage for Cats(unspecified)(Imidacloprid) 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

Other

2. Type of animal affected

Cat / Chat

3. Breed

unknown

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

11

7. Weight (provide a range if necessary )

Unknown

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

<=30 min / <=30 min

11. List all symptoms

System

• Unknown
  • Symptom - Other
  • Specify - Hyperthyroidism

• Nervous and Muscular Systems
  • Symptom - Ataxia
  • Symptom - Muscle weakness
  • Symptom - Recumbent

• General
  • Symptom - Vocalizing

• Respiratory System
  • Symptom - Dyspnea

• General
  • Symptom - Death

• Gastrointestinal System
  • Symptom - Salivating excessively
  • Symptom - Weight loss
  • Symptom - Vomiting
  • Symptom - Other
  • Specify - Digestive Tract Disorder

• General
  • Symptom - Cancer
  • Specify - Abdominal Mass
  • Symptom - Other
  • Specify - Abnormal Ultrasound Finding

• Unknown
  • Symptom - Other
  • Specify - Abnormal Test Result

• General
  • Symptom - Neoplasia

• Gastrointestinal System
  • Symptom - Diarrhea

12. How long did the symptoms last?

Unknown / Inconnu

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

Immediately post application, the cat had hypersalivation that resolved within 30 minutes.On an unknown date in approximately Dec-2014, the cat had vomiting, and weight loss. The cat was examined by a veterinarian and the large intestines felt thickened upon palpation. An abdominal radiograph was performed and an abdominal mass was noted. An abdominal ultra sound was performed and he mass was noted on the outside of the intestinal wall. The mass was biopsied and was reported as cancer. No veterinary treatments were provided.On unknown dates, the owner performed unknown holistic treatments to the cat and administered unknown holistic medications orally to the cat.On unknown date in approximately Dec-2014, the cat had diarrhea and had lost more weight. The cat was examined by the veterinarian and an blood panel was performed and the cat was diagnosed with hyperthyroidism. The cat was prescribed methimizole ointment to be applied the ear daily. The cat was sent home with a peripheral intravenous catheter and some intravenous fluids to be administered daily to the cat. On approximately 11-Jan-2015, the intravenous fluid treatment was not performed.On 12-Jan-2015, the owner administered a double intravenous fluid treatment to the cat. The cat was ataxic and weak. The cat became recumbent, vomited once had vocalization and open mouth breathing. The cat died on its own after arriving at the emergency veterinary clinic. No 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

Update 05.02.2015: No more information is expected. This case is closed.