Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2014-0399

2. Registrant Information.

Registrant Reference Number: 2014CK023

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.

16-JAN-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 II (unknown)

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

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7. b) Type of formulation.

Liquid

Application Information

8. Product was applied?

Yes

9. Application Rate.

.8

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 approximately 13-Oct-2013, a female, Unknown Breed feline, in unknown condition, with a current flea infestation, was administered 1 tube of Advantage II (cat-unspecified) (Imidacloprid-Pyriproxyfen) once topically by the owner. Update 2013-11-08:On approximately 13-Oct-2012, a 13 year old, 6 pound, spayed female, Domestic Shorthair feline, in good condition, with a concomitant medical condition of complete hearing loss, was administered a partial tube of Advantage II Large Cat (Imidacloprid-Pyriproxyfen) once topically by the owner. This is an off label use of the product.

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 short hair

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

13

7. Weight (provide a range if necessary )

6

lbs

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

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

11. List all symptoms

System

• General
  • Symptom - Death

• Nervous and Muscular Systems
  • Symptom - Seizure

• Eye
  • Symptom - Blindness (permanent)

• General
  • Symptom - Hesitancy to move
  • Symptom - Hyperactivity

• Blood
  • Symptom - Hypokalemia

• Nervous and Muscular Systems
  • Symptom - Bizarre behaviour

• Gastrointestinal System
  • Symptom - Anorexia
  • Symptom - Vomiting

12. How long did the symptoms last?

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

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

On an unspecified date, approximately 1 day post application, the cat began having seizures. The cat was seen by a veterinarian and unknown treatments were performed. On approximately 16 Oct 2013 the cat passed away. It is not known if a necropsy was performed. Update 2013-11-08: Immediately after product application the cat ran away. This behavior resolved within 10 minutes. An undetermined amount of time later the cat developed pruritus. Fleas were visible on the pet.The product was applied monthly (partial tube) from Nov 2012 thru Jan 2013 and the cat continued to have pruritus. On an unspecified date after the product was applied on 13 Feb 2013 the cat became blind. A cause for the vision loss was not determined. Continued partial tube product applications occurred from March 2013 thru 13 Sept 2013. The cat continued to have pruritus.On 06 Oct 2013 a partial tube of product was applied.On 16 Oct 2013 the seemed disoriented, anorexic and had one episode of vomiting.On 17 Oct 2013 the cat had a behavioral change going from episodes of hyperactivity to reluctancy to move. The cat then began paddling. Due to the clinical signs the cat was seen by the attending veterinarian. Unknown diagnostics and blood work were performed and revlealed the cat was hypokalemic. Unknown treatments were initiated and the cat began to improve on 18 Oct 2013; however later that day the cat began paddling again and shortly after passed away. No necropsy was performed. The attending veterinarian was suspicious this cat had an undiagnosed neoplasia.

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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

Seizures and death are inconsistent with pharmacotoxicological product profile and experience and therefore not expected. Time to onset time with 10 days too long. Product has wide margin of safety. Oral LD50 in rat 642 mg/kg BW. 24-fold overdosage tolerated by cats without showing any side effect. Neither signs, nor time to onset nor chronology consistent with pharmaco-toxicological product proile. Previous exposure with no adverse reaction for already more than one year. The underlying cause of death of this cat was more likely due to an undiagnosed neoplasia according to case description as no necropsy was performed. Other medical problems also more likely in geriatric cat as indicated by hypokalemia which is probable cause for neurological signs. Based on the toxicological profile and inconsistent chronology a product relation is considered unlikely.