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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

Update the report

Incident Report Number: 2013-6971

2. Registrant Information.

Registrant Reference Number: 2013CK102

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.

03-DEC-13

5. Location of incident.

Country: CANADA

Prov / State: ONTARIO

6. Date incident was first observed.

04-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. 25129      PMRA Submission No.       EPA Registration No.

Product Name: Advantage 18

  • Active Ingredient(s)
    • IMIDACLOPRID

7. b) Type of formulation.

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).

6yr MN domestic long hair Indoor/Outdoor Cat seen by mobile veterinary clinic with severe flea infestation on September 26th 2013. Advantage 18 was applied by DVMs assistant to owners 2 cats according to label directions at that time. Advantage 18 was re-applied every 2-3 weeks by DVM's assistant till date of report.

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

Cat / Chat

3. Breed

Domestic long hair

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

6

7. Weight (provide a range if necessary )

4.5

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

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

11. List all symptoms

System

  • Nervous and Muscular Systems
    • Symptom - Paresis
  • Renal System
    • Symptom - Anuria
    • Specify - decreased frequency of urination
  • General
    • Symptom - Lethargy
  • Blood
    • Symptom - Anemia
    • Symptom - Leukopenia
    • Specify - mild lymphopenia
    • Symptom - Leukopenia
    • Specify - mild neutropenia
  • Nervous and Muscular Systems
    • Symptom - Disorientation
    • Specify - propioceptive deficits

12. How long did the symptoms last?

>2 mos and <=6mos />2 mois et <=6mois

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

Not recovered / Non rétabli

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

October 4th, owner reported that 1 cat hadnt urinated for 3 days (but had been outside during that time). Examined by DVM October 4th: cat was quiet, alert, responsive but appeared weak. Large flaccid bladder palpated. Urinated during examination. Urinalysis: unremarkable SG 1.053, pH 6.5, no blood or ketones present. +1 protein. No crystals. CBC showed mild anemia, mild lymphopenia, mild neutropenia. Blood chemistry/electrolytes within normal limits. Mycoplasma PCR negative. Examined by veterinarian again mid November: cat was quiet, alert, responsive, weak on all 4 legs, proprioceptive deficits in all 4 legs, staring into space. Owner reported that he defecated every 2nd day and urinated every 2-3 days. Veterinarian able to express bladder normally. Cat has been maintained indoors since October 4th. owner reported that affected cat was quieter for 24 hours subsequent to each Advantage treatment. Pet was treated Sept 26 and every 2-3 weeks after that.


To be determined by Registrant

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

Major

19. Provide supplemental information here

The owners other cat has remained normal throughout treatment period. Status update: On march 3rd- the veterinarian contacted Bayer to say that the cat was euthanized on February 28th, 2014 due to deterioration in nuerological signs including recumbency, rigidity, vertical nystagmus.