Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2016-7940

2. Registrant Information.

Registrant Reference Number: 2016KP221

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.

18-OCT-16

5. Location of incident.

Country: UNITED STATES

Prov / State: UNKNOWN

6. Date incident was first observed.

09-SEP-16

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. 11556-128

Product Name: k9 advantix II small dog

• Active Ingredient(s)
  • IMIDACLOPRID
    • Guarantee/concentration 9.1 %
  • PERMETHRIN
    • Guarantee/concentration 44 %
  • PYRIPROXYFEN
    • Guarantee/concentration .46 %

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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 09-Sep-2016, a 9 year old, 4.9 pound, neutered, female,Pomeranian canine, in poor condition, with a concomitant collapsing trachea, who was being administered unknown oral doses of torbugesic and diphenhydramine daily since2016, was administered 1 tube of K9 Advantix II Small Dog(Imidacloprid-Permethrin-Pyriproxyfen) 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

Other

2. Type of animal affected

Dog / Chien

3. Breed

Pomeranian

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

9

7. Weight (provide a range if necessary )

4.9

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

>30 min <=2 hrs / >30 min <=2 h

11. List all symptoms

System

• General
  • Symptom - Death

• Skin
  • Symptom - Pruritus

• General
  • Symptom - Hyperactivity

• Respiratory System
  • Symptom - Panting
  • Symptom - Difficulty Breathing

• Blood
  • Symptom - Other
  • Specify - Thrombosis

• Cardiovascular System
  • Symptom - Cardiac arrest

• Nervous and Muscular Systems
  • Symptom - Agitation

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?

Yes

14. b) How long was the animal hospitalized?

1

Day(s) / Jour(s)

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 one hour following the application of product, the dog became pruritic, agitated, and began panting. The owner bathed the dog with liquid dish soap. The dog presented to the emergency clinic. The dog was hospitalized due to difficulty breathing. The dog was administered torbugesic with acepromazine intravenously (unknown dose), dexamethasone (unknown dose) intravenously, and diphenhydramine (unknown dose) intravenously. The dog was placed in an oxygen cage. On 10Sep2016 the dog was released into the owners' care. On 11Sep2016, the dog presented to the emergency clinic with difficulty breathing. The dog was started on intravenous fluids and placed in an oxygen cage. Chest radiographs, complete blood count, and blood gases were performed. The dog was administered acepromazine (unknown dose), diazepam (unknown dose), prednisone, and diphenhydramine. The dog continued to worsen. The dog was administered butorphanol with intermittent midazolam and acepromazine (unknown doses), and manual ventilation was started. Bloodwork revealed coagulopathy. On 12Sep2016, the dog went into cardiac arrest and died. No necropsy was performed. No further information is expected. This case is closed. Follow up received on 4th Oct 2016: On 09-Sep-2016, a 9 year old, 4.9 pound, neutered, female, Pomeranian canine, in poor condition, with a concomitant collapsing trachea, who was administered unknown oral doses of butorphanol tartrate and diphenhydramine daily since 2016 for the concomitant medical condition, was administered 1 tube of K9 Advantix II Small Dog (Imidacloprid-Permethrin-Pyriproxyfen) topically by the owner. Approximately 3 hours post application, the dog was examined by the emergency veterinarian, administered unspecified doses of intravenous torbugesic, intravenous acepromazine maleate, intravenous dexamethasone, and intravenous diphenhydramine. The dog was hospitalized in an oxygen cage and the collar was removed. On 10 Sep2016, the clinical signs continued but improved and dog was discharged to the owner. On 11Sep2016, the dog exhibited difficulty breathing and was examined by the emergency veterinarian. Thoracic radiographs, complete blood count, and blood gases were performed; the results are unknown. The dog was administered unspecified doses of acepromazine maleate, diazepam, prednisone, and diphenhydramine. The clinical signs worsened. The dog was administered unspecified doses of butorphanol tartrate via constant rate infusion with intermittent dose of intravenous midazolam and acepromazine maleate. An endotracheal tube was placed and manual ventilation was performed. Bloodwork revealed disseminated intravascular coagulation.

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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

Though would not expect generalized skin disorders after topical application, reported pruritus and agitation may reflect paresthesia caused by permethrin. Panting is not expected however rather consequence of agitation. Time to onset consistent. Further reported difficulty in breathing is not expected either. Other causes should be considered, e.g. concomitant medical condition of collapsing trachea. Reported disseminated intravascular coagulation and cardiac arrest are not anticipated after product application as they are inconsistent with pharmaco-toxicological product profile. The dog likely died due to serious underlying condition. Even though time to onset is short for initially reported signs, considering long time to onset for further reported unexpected signs, a product relation is deemed to be unassessable.