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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2016-3532

2. Registrant Information.

Registrant Reference Number: 2016CK076

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.

17-MAY-16

5. Location of incident.

Country: CANADA

Prov / State: ONTARIO

6. Date incident was first observed.

02-FEB-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)

PMRA Registration No. 27581      PMRA Submission No.       EPA Registration No.

Product Name: advantage II small dog

  • Active Ingredient(s)
    • IMIDACLOPRID
    • PYRIPROXYFEN

7. b) Type of formulation.

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).

A 6yr female 2.8kg nursing dam Chihuahua with a history of fleas and recent caesarean following dystocia and vaginal prolapse was treated with 1 tube of advantage II small dog on February 1st 2016. This dog was also receiving oral clavaseptin antibiotics. Note there was no known direct contact between the puppy and the advantage II however, the puppy was exposed to the treated dam

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

Medical Professional

2. Type of animal affected

Dog / Chien

3. Breed

chihuahua

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

0.03

7. Weight (provide a range if necessary )

0.07

kg

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
  • Respiratory System
    • Symptom - Abnormal lung sounds
    • Symptom - Other
    • Specify - agonal breathing
  • Gastrointestinal System
    • Symptom - Other
    • Specify - weak suckle reflex

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?

Yes

14. b) How long was the animal hospitalized?

2

Day(s) / Jour(s)

15. Outcome of the incident

Died

16. How was the animal exposed?

Contact treat.area/Contact surf. traitée

17. Provide any additional details about the incident

(eg. description of the frequency and severity of the symptoms

on February 2nd, 11hrs after product application, a 1 day old male 75g Chihuahua puppy had pulmonary crackles, weak suckle reflex, hypothermia and agonal breathing. the puppy was treated with dextrose, a heat lamp and fed by tube feeding. the puppy died the same day. The puppy was the only surviving puppy of the litter. The other puppies were not born alive and were found mummified or dead with severe birth defects (cleft palate or eviscerated chest and abdominal contents). The attending veterinarian suspected that the puppy died from aspiration pneumonia or congenital defect. The pet owners declined a necropsy.


To be determined by Registrant

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

Death

19. Provide supplemental information here