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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2017-0688

2. Registrant Information.

Registrant Reference Number: 2017KP010a

Registrant Name (Full Legal Name no abbreviations): Bayer Inc

Address: 2920 matheson BLVD

City: Mississaugua

Prov / State: ON

Country: Canada

Postal Code: L4W 5R6

3. Select the appropriate subform(s) for the incident.

Domestic Animal

4. Date registrant was first informed of the incident.

27-JAN-17

5. Location of incident.

Country: UNITED STATES

Prov / State: UNKNOWN

6. Date incident was first observed.

13-OCT-16

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).

On 01-Oct-2016, a 5.5 year old, 11 pound, neutered, male,Domestic Longhair feline, in poor condition, with concomitant medical conditions of fleas, pruritus and skin lesions, was administered 1 tube of Advantage II Small Cat (Imidacloprid-Pyriproxyfen) topically by the owner. This was an off label use of the product as it was a low dose for this cat.

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 Longhair

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

5.5

7. Weight (provide a range if necessary )

11

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
  • Skin
    • Symptom - Pruritus
    • Symptom - Lesion
  • General
    • Symptom - Vocalizing

12. How long did the symptoms last?

Persisted until death

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

On 13 Oct 2016, the pruritus and skin lesions worsened. The cat was not examined by a veterinarian and the clinical signs continued. Follow up received on 7th Nov 2016: On 13 Oct 2016, the pruritus and skin lesions worsened. The cat was not examined by a veterinarian and the clinical signs continued. The owner administered another tube of Advantage II Small Cat (Imidacloprid-Pyriproxyfen) topically by the owner. This was again, an off label use of the product as it was a low dose for this cat. The clinical signs continued. On 05 Nov 2016, the cat was administered 1 tube of Advantage II Large Cat (Imidacloprid-Pyriproxyfen) topically by the owner. Approximately 30 minutes post application, the cat vocalized and died. The cat was examined by a veterinarian and pronounced dead on arrival. No necropsy was performed.


To be determined by Registrant

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

Death

19. Provide supplemental information here

Pruritus and skin lesions are reported prior to product application, hence not related to the product. Vocalization is an unspecific sign and may have numerous other causes. Death is not expected after product application as inconsistent with pharmaco-toxicological product profile. Other causes should be considered. No signs of allergic/anaphylactic reaction reported. Product has wide margin of safety. Oral LD50 in rat is 642 mg/kg BW. 24-fold over dosage tolerated by cats without showing any side effect. Animal involved in this case was in poor health condition, which may have further contributed to death of the animal. Product was well tolerated to previous application of the product. However, considering short time to onset and no necropsy was performed, a product connection is unassessable.