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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2013-3237

2. Registrant Information.

Registrant Reference Number: 2013AM142

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.

13-JUN-13

5. Location of incident.

Country: UNITED STATES

Prov / State: UNKNOWN

6. Date incident was first observed.

14-JUL-11

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 152

Product Name: Advantage II large cat

  • 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).

One vial of Advantage II large cat was applied topically by the owner to one spot on the dorsal midline.

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 shorthair

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

9

7. Weight (provide a range if necessary )

14

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

>24 hrs <=3 days / >24 h <=3 jours

11. List all symptoms

System

  • General
    • Symptom - Death
  • Nervous and Muscular Systems
    • Symptom - Difficulty walking
    • Specify - not willing to walk
  • General
    • Symptom - Lethargy
  • Skin
    • Symptom - Pale mucous membrane colour
  • Blood
    • Symptom - Anemia
    • Specify - low RBC and hemoglobin
    • Symptom - Other
    • Specify - low hematocrit
    • Symptom - Thrombocytopenia
    • Symptom - Other
    • Specify - low neutrophils

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?

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

11July2011 owner applied Advantage II Large Cat to Gabrielle a 9 year old male Domestic Shorthair that weighs 14 pounds for flea infestation. Less then 8 hours after application this feline lethargic. On 14July2011 this feline was not willing to walk. Veterinary examination this cat presented at the clinic with white / pale mucous membranes, body temperature of 94.8 degrees, obese according to the doctor. This feline weighed 14.8 pounds and should have weighed about 11 pounds. That was the first time this doctor had seen this feline. This feline died during the examination process. The DVM drew blood (which was very thin) and sent it out - a CBC and path report are pending. The doctor wants to rule out a flea-borne disease. No necropsy was preformed. Update 20.07.2011: On 16July2011 the veterinarian got CBC results from Antech: Low RBC 3.96 (5.92-9.93), Low Hemaglobin 6.8 (9.3-15.9), Low Hematocrit 21.9 (29-48), Low Platelet count 15 (200-500), Low Neutrophils 2064 (2500-8500), Antech recommended PCR test and that is pending. Blood smear=Poylchromasia is almost moderate but still not enough to raise the pcb. Cytauxzoon organisms were not identified. PCR was negative. Update 09.09.2011: The veterinarian received results for Past Panel PCR Feline Haemotropic Mycoplasma Panal: Mycoplasma hemofelis negative, Mycoplasma Haemominutum Negative, and Mycoplasma Turicensis Negative. No more information expected.


To be determined by Registrant

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

Death

19. Provide supplemental information here

Lethargy may exceptionally occur in particular sensitive animals. Other signs not expected after topical product application as inconsistent with pharmaco-toxicological product profile. Onset time of 3 days for other signs, argues against anaphylactic reaction. Lab results indicate also other cause, see low values for almost all parameters. Samples negative for mycoplasma. However, product relation furtheron considered unlikely.