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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2013-6289

2. Registrant Information.

Registrant Reference Number: 2013CK033

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.

21-OCT-13

5. Location of incident.

Country: UNITED STATES

Prov / State: UNKNOWN

6. Date incident was first observed.

04-AUG-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. 11556-128

Product Name: Advantage II Small 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.

.8

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 10 Jul 2013, a 10 week old, 5 pound, intact, female, mixed breed canine, in poor condition, with a flea infestation and severe hookworm infection, was administered 1 tube of Drontal Plus Tablets Small (Praziquantel Pyrantel Pamoate Febantel) once orally by the attending vet. This dog also received one tube of Advantage II for Small dogs (imidacloprid, pyroproxifen) topically by the attending veterinarian, and was given 1.0 ml of compounded Marquis (ponazuril) 100mg/ml orally one time. On 26Jul2013 the dog was given 1.0 ml of compounded Marquis (ponazuril) 100mg/ml.

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

Cross Breed

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

0.2

7. Weight (provide a range if necessary )

5

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 - Death
  • Gastrointestinal System
    • Symptom - Other
    • Specify - severe hemorrhagic gastroenteritis

12. How long did the symptoms last?

Unknown / Inconnu

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

On 04Aug2013 the dog was found deceased. On 05Aug2013 the dog presented to the veterinarian for gross necropsy. Upon gross examination the dog was found to have severe hemorrhagic gastroenteritis. A parvovirus test was performed and found to be negative. The liver, spleen, heart, lungs, and kidneys all appeared normal on gross examination. The owner declined further testing.


To be determined by Registrant

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

Death

19. Provide supplemental information here

Unexplained death is inconsistent with pharmacotoxicological product profile and experience. No signs of allergic/anaphylactic reaction 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. Finally the onset time of 25 days allows the exclusion of a product relation.