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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2013-3271

2. Registrant Information.

Registrant Reference Number: 2013AM162

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)

PMRA Registration No.       PMRA Submission No.       EPA Registration No. 11556 144

Product Name: K9 Advantix II extra large dog

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

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).

One vial of K9 Advantix II extra large 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

Crossbreed

4. Number of animals affected

1

5. Sex

Unknown

6. Age (provide a range if necessary )

9

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

>2 hrs <=8 hrs / > 2 h < = 8 h

11. List all symptoms

System

  • General
    • Symptom - Death
  • Gastrointestinal System
    • Symptom - Vomiting
  • Respiratory System
    • Symptom - Coughing
    • Specify - coughing up white phlegm
  • Gastrointestinal System
    • Symptom - Retching
    • Specify - dry heaves
    • Symptom - Gagging
  • General
    • Symptom - Pale mucous membrane colour
    • Specify - gums appeared very pale
  • Gastrointestinal System
    • Symptom - Bloating
  • Respiratory System
    • Symptom - Dyspnea
  • Gastrointestinal System
    • Symptom - Other
    • Specify - gastric torsion
  • General
    • Symptom - Neoplasia

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

Caller applied product to dog 3 hours ago. Dog developed vomiting 1.5 hours ago. Dog vomited "40" times. Caller did not witness dog ingesting product, but believes this is what happened. Caller phoned his DVM and the receptionist told caller the dog was "dying from the product". Caller is bathing dog now with dish soap. [Name] called back and stated that her dog died before she was able to get it to dvm. She expressed her concerns with the product and stated "she is going to take to company to court". Cb from owner at 10:51pm: Apparently Max ate dinner as usual this evening. After application, he developed vomiting and owner sent dog outside. Owner believes dog vomited 40 times outside. When dog came back in, he was gagging and coughing up white phlegm, then just had dry heaves. His gums appeared very pale. Dog became bloated about 1 hour ago. After phoning SCI, owner was bathing dog with dish soap, when dog became dypsnic, lyed down in the shower, and died. The attending veterinarian will be performing a gross necropsy on Max this evening to try to determine the cause of death. A gross necropsy was performed on 21Jun11. It is suspected the cause of death was due to gastric torsion. Max also had pancreatic abnormalities indicative of a neoplasia.


To be determined by Registrant

18. Severity classification (if there is more than 1 possible classification

Death

19. Provide supplemental information here

Signs are not expected after topical product application as inconsistent with the pharmaco-toxicological product profile. It was deemed the cause of death was due to gastric torsion and the suspected pancreatic disorder and not product related.