Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2013-3273

2. Registrant Information.

Registrant Reference Number: 2013AM164

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

Address: 77 Belfield Rd

City: Toronto

Prov / State: ON

Country: Canada

Postal Code: M9W 1G6

3. Select the appropriate subform(s) for the incident.

Domestic Animal

4. Date registrant was first informed of the incident.

13-JUN-13

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. 11556 142

Product Name: K9 Advantix II medium dog

• Active Ingredient(s)
  • IMIDACLOPRID
    • Guarantee/concentration 8.8 %
  • PERMETHRIN
    • Guarantee/concentration 44 %
  • PYRIPROXYFEN
    • Guarantee/concentration .44 %

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7. b) Type of formulation.

Liquid

Application Information

8. Product was applied?

Yes

9. Application Rate.

1

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).

One vial of K9 Advantix II medium dog was applied topically by the owner to one spot on the dorsal midline.

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

Cat / Chat

3. Breed

Domestic longhair

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

3

7. Weight (provide a range if necessary )

13

lbs

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

• General
  • Symptom - Death
  • Symptom - Hyperthermia
  • Symptom - Hypothermia

• Nervous and Muscular Systems
  • Symptom - Muscle tremors

• General
  • Symptom - Adipsia

• Gastrointestinal System
  • Symptom - Anorexia

• General
  • Symptom - Hiding
  • Symptom - Listless

• Skin
  • Symptom - Jaundice

• Blood
  • Symptom - Hyperglycemia

• Renal System
  • Symptom - Creatinine increased

• Blood
  • Symptom - Blood urea nitrogen increased
  • Specify - elevation of BUN

12. How long did the symptoms last?

Unknown / Inconnu

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

Unknown

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

Rasta is a 3 year old, female spayed, domestic long hair weighing 13 pounds in good health. Rasta is an indoor/outdoor cat. On 14Aug11 a partial tube of K9 Advantix II Medium dog was applied to the cat. On 15Aug11 the cat presented to the veterinary clinic with muscle tremors and a fluctuating body temperature (hyperthermia/hypothermia). Rasta was bathed and treated with subcutaneous fluids and injectable valium. Blood work was performed and was within normal limits. On 16Aug11 all symptoms had resolved, the cat was eating and drinking and therefore discharged from the clinic. Upon arrival home the cat went outdoors and hid under a shed for two days. On 18Aug11 Rasta presented back to the veterinary clinic listless and icteric. Blood work was repeated and revealed hypoglycemia (glucose 34), total bilirubin 4.7, and an elevation of BUN and Creatinine. Follow-up, 20 Sept 2011: The attending veterinarian states that Rasta's blood glucose levels continued to drop throughout the day and the cat was placed on IV dextrose. The cat was eventually intubated to be placed on a respirator; however shortly after intubation the cat passed away. The attending veterinarian states the cat went into disseminated intravascular coagulation and does not feel this to be product related. No necropsy examination 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

Initial signs consistent with permethrin toxicity, however icterus, abnormal renal enzymes and hypoglycaemia are not in line with permethrin intoxication. Cat recovered fully from permethrin toxicity and was discharged from clinic. Once home, the cat hid for 2 days under shed. Unknown what may have transpired during that time frame and if cat possibly had access to posion. Attending DVM does not consider latter clinical signs and fatal outcome product related. Hence, other unknown causes deemed to be more likely and product involvement considered unlikely for this event.