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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2017-0691

2. Registrant Information.

Registrant Reference Number: 2017KP012

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.

27-JAN-17

5. Location of incident.

Country: UNITED STATES

Prov / State: UNKNOWN

6. Date incident was first observed.

12-OCT-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.       PMRA Submission No.       EPA Registration No. 11556-127

Product Name: advantage II large dog

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

7. b) Type of formulation.

Liquid

Application Information

8. Product was applied?

Yes

9. Application Rate.

2.5

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 11-Oct-2016, a 4 year old, 25 pound, neutered, male,Spaniel (Cocker) canine, in unknown condition, with no known concomitant medical conditions, was administered 1tube of Advantage II Large Dog (Imidacloprid-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

Cocker Spaniel

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

4

7. Weight (provide a range if necessary )

25

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

>24 hrs <=3 days / >24 h <=3 jours

11. List all symptoms

System

  • General
    • Symptom - Death
  • Renal System
    • Symptom - Renal failure
  • Liver
    • Symptom - Hepatic failure
  • General
    • Symptom - Lethargy
  • Renal System
    • Symptom - Inappropriate urination
  • Gastrointestinal System
    • Symptom - Oral hemorrhage
  • Blood
    • Symptom - Other
    • Specify - Coagulation Abnormality
  • Gastrointestinal System
    • Symptom - Other
    • Specify - Digestive Tract Haemorrhage
  • General
    • Symptom - Hypothermia
  • Nervous and Muscular Systems
    • Symptom - Other
    • Specify - Lockjaw
  • Blood
    • Symptom - Other
    • Specify - Haemorrhage

12. How long did the symptoms last?

Unknown / Inconnu

13. Was medical treatment provided? Provide details in question 17.

Yes

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

On 12-Oct-2016, the canine exhibited inability to walk, inappropriate urination, blood coming from the mouth, and petechiation on the abdomen and on the gums. The canine was examined by a veterinarian and exhibited bloody diarrhea, a low temperature and a locked jaw. The veterinarian performed unspecified blood work; results revealed internal bleeding, kidney failure and liver failure. At an unspecified time post onset of signs, on 12-Oct-2016, the canine died. No necropsy was performed.


To be determined by Registrant

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

Death

19. Provide supplemental information here

Reported weakness, inappropriate urination, blood coming from mouth, petechiation on abdomen and on gums, bloody diarrhea, low temperature and locked jaw are not expected after product application and may probably be associated with later diagnosed internal bleeding, kidney failure and liver failure. Further internal bleeding, kidney failure, liver failure and death are not expected either, as signs inconsistent with pharmacotoxicological product profile. Product has wide margin of safety. Oral LD50 in rat 642 mg/kg BW. 20-fold overdosage tolerated by dogs without showing any side effect. Death may likely be a consequence to internal bleeding, kidney failure and liver failure observed in an animal. Even though time to onset is short and although no necropsy was performed, considering known safety profile of the product and the most prominent sign death which characterizes this case, no plausible connection can be made to the product and a product relation is deemed to be unlikely.