Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2013-3272

2. Registrant Information.

Registrant Reference Number: 2013AM163

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

Dog / Chien

3. Breed

unknown

4. Number of animals affected

1

5. Sex

Unknown

6. Age (provide a range if necessary )

7

7. Weight (provide a range if necessary )

Unknown

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

• Respiratory System
  • Symptom - Laboured breathing

• General
  • Symptom - Other
  • Specify - swollen lymph nodes

• Respiratory System
  • Symptom - Panting

• General
  • Symptom - Hyperthermia
  • Specify - hyperthermic

• Respiratory System
  • Symptom - Dyspnea
  • Symptom - Chest congestion
  • Specify - lung congestion

• Skin
  • Symptom - Cyanosis
  • Specify - cynotic
  • Symptom - Pruritus
  • Symptom - Itchy skin
  • Specify - scratching

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

The owner applied the K9 Advantix 20 to the dog on 7/16/11. Immediately after the application the dog started scratching at the application site and her face. On 7/17/11 the owner noticed that the pruritus was still ongoing, however the dog also developed labored breathing. Today (7/18/11) the dog is at the clinic because of ongoing clinical signs. The dog is now cynotic, has caused self trauma on the face and application site, has swollen lymph nodes, is panting and is also hyperthermic. The dog is currently being hospitalized, however no other treatments have been done. This was the first time use of the product. 20July11 - Macie had radiographs performed at the attending veterinarians office and had unknown treatments for shock on 18July11. The radiographs were within normal limits. At 7:30PM the dog was transferred to a 24 hour Veterinary Emergency Care facility and presented with dyspnea. Radiographs were again taken and revealded congestion in the lungs. The dogs temp was 101.0. Macie was placed on oxygen and at 9:30PM she was relaxed and alert. At 9:55PM the dog was deceased. No necropsy was performed. Update 05.08.2011: Reviewed medical records and found that the dog had a history of severe periodontal disease and gingivitis from 2007 until 2011. Also the dog had a history of bilateral luxating patellas since 2008 to 2011. On 6/9/11 it was reported to the clinic that the dog had a decreased appetite and no bowel movement for 3 days. Prior to this the dog had loose stools that looked like jelly for 3 days. Also the owner had noticed a sore on the dogs mouth and facial pruritus. No further information is expected.

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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

Application site pruritus may be local dermal sensitivity to product. Other signs described not expected as inconsistent with pharmaco-toxicological product profile. Signs potentially could indicate allergic pathogensis, but chronolgy not suggestive for allergic cause related to product. Would not expect fatal outcome inspite of medical intervention (shock treatment). Dogs health history mentioned ongoing medical disorders. Thus, more likely these responsible for signs and fatal outcome. However, without post-mortem examination reliable causality assessment not possible. The technical revision of the complained batch did not reveal any deviation from the specification.