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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2010-2859

2. Registrant Information.

Registrant Reference Number: 2010CP001

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.

01-MAR-10

5. Location of incident.

Country: CANADA

Prov / State: QUEBEC

6. Date incident was first observed.

11-FEB-10

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. 25131      PMRA Submission No.       EPA Registration No.

Product Name: advantage100

  • Active Ingredient(s)
    • IMIDACLOPRID

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).

one tube advantage 100 was applied to the dirsal midline, in 4 spots

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

german shepherd mix

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

12

7. Weight (provide a range if necessary )

26

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

>2 hrs <=8 hrs / > 2 h < = 8 h

11. List all symptoms

System

  • Nervous and Muscular Systems
    • Symptom - Muscle weakness
    • Symptom - Ataxia
  • General
    • Symptom - Pain
  • Nervous and Muscular Systems
    • Symptom - Abnormal gait
  • Gastrointestinal System
    • Symptom - Diarrhea

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?

Yes

14. b) How long was the animal hospitalized?

4

Day(s) / Jour(s)

15. Outcome of the incident

Recvrd resid.effects/Rétabli séquelles

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 feb 11, owner applied advantage to treat the lice. The dog received cephalexin as an antibiotic post dentistry as it had severe gingivitis. On feb 11 in the evening, the dog became weak the hind legs which progressed to the front legs; on feb 22 the dog was examined and prednisone was prescribed; discussed case with DR (name). on March 01 ; the dog's condition was stable and suggested referral to see a neurologist; dog is at the referral center now, ongoing tests; no diagnosis has been made yet When it arrived at the referral center on March 04, it was ataxic and seemed painful in the neck area. Xrays of the thoracic spine were done, also MRI of the head and neck, CSF tap, CBC and biochemistry. None of the tests were conclusive, the main suspicion now is encephalitis. The dog was treated with torbugesic, gabapentin and dexamethasone while at the referral centre; it developed diarrhea and was given famotidine and metronidazole to treat it; it improved clinically over the weekend and was sent home on Monday morning, March 8.


To be determined by Registrant

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

Major

19. Provide supplemental information here

The dog received many medications one day before the onset of clinical signs which possibly have contributed to the signs