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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2016-4186

2. Registrant Information.

Registrant Reference Number: 2016KP090

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-JUL-16

5. Location of incident.

Country: UNITED STATES

Prov / State: UNKNOWN

6. Date incident was first observed.

30-DEC-15

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. 11556-125

Product Name: advantage II medium 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.

1

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 approximately 20-Nov-2015, a 14 year old, 13 pound,neutered, male, Dachshund (Miniature) canine, in fair condition, with concomitant conditions of a heart murmur,nasal mucus, and fleas, was administered 1 tube of Advantage II Medium 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

Miniature Dachshund

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

14

7. Weight (provide a range if necessary )

13

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

>1 wk <=1 mo / > 1 sem < = 1 mois

11. List all symptoms

System

  • General
    • Symptom - Lethargy
    • Symptom - Death
  • Cardiovascular System
    • Symptom - Heart murmur
  • Respiratory System
    • Symptom - Chest congestion

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

On approximately 30-Dec-2015, the canine exhibited lethargy, was examined by the veterinarian and was diagnosed with an increase in the severity of the heart murmur and pulmonary congestion. No known treatments were performed. On 20-Apr-2016, the canine was administered 1 tube of Advantage II Medium Dog (Imidacloprid-Pyriproxyfen) topically by the owner. On 01-May-2016, the canine died. No necropsy was performed. No further information is expected. This case is closed.


To be determined by Registrant

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

Death

19. Provide supplemental information here

Severe heart murmur and pulmonary congestion are neither expected nor in line with pharmaco-toxicological product profile. Animal had concomitant history of heart murmur and nasal discharge, which likely contributed to the sign. Lethargy is consequence of other reported signs. Death was reported after second application of the product. Death is not expected after product application, as inconsistent with pharmaco-toxicological product profile. No signs of allergic/anaphylactic reaction reported in close proximity of product application. 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. Further the animal reported in this case was in advanced age which may have pre-disposed it to such critical condition. Time to onset not suggestive of product involvement either. In the end even though no necropsy was performed sufficient information exists to rule out the product involvement.