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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2014-0392

2. Registrant Information.

Registrant Reference Number: 2014CK016

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.

03-SEP-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. 11556-130

Product Name: Advantage II Extra 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.

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).

On 03-Sep-2013, a 6 week old, 2.8 pound, intact, male, Domestic Shorthair feline, in good condition and with no concomitnant conditions, was administered an unknown amount of Advantage II Extra 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?

No

Subform III: Domestic Animal Incident Report

1. Source of Report

Animal's Owner

2. Type of animal affected

Cat / Chat

3. Breed

domestic short hair

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

0.11

7. Weight (provide a range if necessary )

2.8

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

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

11. List all symptoms

System

  • General
    • Symptom - Death
  • Nervous and Muscular Systems
    • Symptom - Muscle tremors

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

Approximately 4 hours following application, the feline began having severe tremors.. On 04 Sep 2013, the attending veterinarian examined the feline and found severe tremors. The feline was given an unknown amount of diazepam, but the tremors did not stop. Update 2013-10-10. This product is labeled for canines. Its use on a feline is off-label. Approximately 4 hours following application, the feline began having severe tremors. On 04 Sep 2013, the attending veterinarian examined the feline and found severe tremors. The feline was given an unknown amount of diazepam, but the tremors did not stop. The feline received no further treatment and died. No necropsy was performed. No further information is expected. This case is closed.


To be determined by Registrant

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

Death

19. Provide supplemental information here

Muscle tremor is not typically observed with appropriate topical product administration. Oral product exposure was not reported but might be assumed as other cats in household also had tremors (US-2013-185187//185235//185237). Assumable administration of an overdose in this young animal took place. However, death is not expected as inconsistent with pharmaco-toxicological product profile, even after overdose. Product has wide margin of safety. Oral LD50 in rat 642 mg / kg BW. 24-fold overdosage tolerated by cats without showing any side effect. Product/active ingredients were shown to have no negative effect in kitten nursing treated cats. Short time to onset. Other etiologies in such a young cat are more likely e.g. infection. As time to onset short and no necropsy or further diagnostics available , a relation of fatal outcome with the product is unassessable