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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2014-0689

2. Registrant Information.

Registrant Reference Number: 2013CK131

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.

11-JUN-13

5. Location of incident.

Country: CANADA

Prov / State: NOVA SCOTIA

6. Date incident was first observed.

07-JUN-13

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. Unknown

Product Name: K9 Advantix (unknown size)

  • Active Ingredient(s)
    • IMIDACLOPRID
    • PERMETHRIN

7. b) Type of formulation.

Application Information

8. Product was applied?

Yes

9. Application Rate.

Unknown

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 07-Jun-2013, a 8 year old, neutered, male, Papillon canine of unknown weight, in good condition with no concomitant medical conditions, was administered 1 tube of Advantix (non - US Registered Product) (Imidacloprid - Permethrin) once topically by the attending vet.

To be determined by Registrant

12. In your opinion, was the product used according to the label instructions?

Unknown

Subform III: Domestic Animal Incident Report

1. Source of Report

Animal's Owner

2. Type of animal affected

Dog / Chien

3. Breed

Papillon

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

8

7. Weight (provide a range if necessary )

Unknown

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 - Lethargy
    • Symptom - Abnormal behaviour
  • Eye
    • Symptom - Glazed eye
  • Nervous and Muscular Systems
    • Symptom - Shaking
  • General
    • Symptom - Vocalizing
  • Nervous and Muscular Systems
    • Symptom - Ataxia
    • Symptom - Muscle twitching
  • Gastrointestinal System
    • Symptom - Vomiting
  • Skin
    • Symptom - Dermatitis
  • Respiratory System
    • Symptom - Difficulty Breathing
  • General
    • Symptom - Swelling
    • Symptom - Tucking tail
    • Symptom - Death

12. How long did the symptoms last?

>1 mo and <= 2mos / >1 mois et < = 2mois

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

Approximately 1 hour post product application the canine began vomiting, became lethargic,he did not want his back touched(behavioral), and his eyes were glassy.Later that day the canine was shaking, growling, could not stand up normally, kept his tail tucked between his legs(behavioral), had muscle twitches along back and sides of his body, his eyes were rolling back, and he was rolling on the floor rubbing his back. On 08Jun2013 the base of his tail was swollen and oozing. The canine was examined by a veterinarian who instructed the owner to take the canine home and bathe him with liquid dish soap multiple times. No other treatments were performed. The owner returned home and bathed the canine as instructed. Follow-up of 2013-07-31: On an unspecified date the dog passed away. It is unknown if a necropsy was performed.Update August 7 2013: contact with (name) Veterinary Hospital. Pet was seen June 10 2013 for the K9 advantix reaction, bloodwork was normal and the pet was deemed to be in good health. No clinical signs were noted. The clinic did note that the pet owner had called to reported the pet was vomiting on the day before K9 advantix was applied. The pet was not seen again after June 10 until it presented July 29 for respiratory distress. The DVM attributed this to hot environmental temperatures but the dog passes away later that night. The cause of death was deemed to be unrelated to K9 advantix use by the DVM.


To be determined by Registrant

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

Death

19. Provide supplemental information here

Vomiting, behavioural disorders and lethargy may be product related. Skin lesions on other sites than application site may be consequence of the rolling on the floor. However, further reported death is not expected as inconsistent with pharmaco-toxicological product profile. Time to onset for death is too long (7 weeks). Other causes are more probable. Dog reported to have been in respiratory distress and death likely related to medical condition. According to consulted veterinarian signs likely related to hot weather. Overall, a product connection particularly with fatal outcome is considered unlikely.