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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2014-0398

2. Registrant Information.

Registrant Reference Number: 2014CK022

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.

16-JAN-14

5. Location of incident.

Country: UNITED STATES

Prov / State: UNKNOWN

6. Date incident was first observed.

14-OCT-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. 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 13 Oct 2013, a 14 year old, 40 pound, intact, female, Mixed Breed canine, in fair condition, with a concomitant medical condition of skin pruritus, scabs/skin lesion and alopecia and ear disorder,was administered 1 tube of Advantage II Large Dog (Imidacloprid-Pyriproxyfen) once 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

Animal's Owner

2. Type of animal affected

Dog / Chien

3. Breed

mixed breed

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

14

7. Weight (provide a range if necessary )

40

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

<=30 min / <=30 min

11. List all symptoms

System

  • General
    • Symptom - Death
    • Symptom - Lethargy
    • Symptom - Vocalizing
  • Gastrointestinal System
    • Symptom - Salivating excessively

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.

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

Immediately after application the dog was lethargic and vocalizing. On 14 Oct 2013 the dog was found dead and had some hypersalivation present in the mouth. 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

Lethargy and vocalisation are unspecific signs and may have various other causes in an animal, but may represent behavioural responses to the product sensation. Short time to onset. Hypersalivation may occur shortly after prodauct application if product is ingested, however, this was not reported. Death not expected after product application, as inconsistent with pharmaco-toxicological product profile. No indicative sign of allergy/anaphylaxis reported. 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. No vet consulted. No reaction on previous exposure. Medical history not suggestive for product relation. Old age of dog and her medical history indicate other more likely causes. However, due to the short time to onset and short chronology as well as no available necropsy or other substantiated cause, product relation is unassessable