Health Canada
Symbol of the Government of Canada
Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2017-2159

2. Registrant Information.

Registrant Reference Number: 2017KP104

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.

19-APR-17

5. Location of incident.

Country: UNITED STATES

Prov / State: UNKNOWN

6. Date incident was first observed.

Unknown

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 an unspecified date in approximately Jan 2017, a 20 year old, approximately 15 pound, neutered, male, Russian Blue feline, in unknown condition, with concomitant skin allergies,was administered 1 tube of Advantage II Large Cat(Imidacloprid-Pyriproxyfen) topically by the owner.

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

Russian Blue

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

20

7. Weight (provide a range if necessary )

15

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 - Lethargy
    • Symptom - Death
  • Skin
    • Symptom - Pruritus
  • Gastrointestinal System
    • Symptom - Diarrhea
    • Symptom - Vomiting
  • Eye
    • Symptom - Pupil dilation
  • Gastrointestinal System
    • Symptom - Weight loss
  • General
    • Symptom - Abnormal behaviour

12. How long did the symptoms last?

>1 mo and <= 2mos / >1 mois et < = 2mois

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 an unspecified date post application, in approximately Feb-2017, the cat exhibited pruritus. On 09-Feb-2017, the owner administered 1 tube of Advantage II Large Cat (Imidacloprid-Pyriproxyfen) topically. Approximately 40 minutes post application, the cat exhibited loose stools, 4 episodes of vomiting, and lethargy. The owner wiped the application site with dish soap and water, but the cat was not examined by a veterinarian and the clinical signs continued. Follow-up received on 24th Mar 2017: On an unknown date in approximately Jan2017, a 20 year old, approximately 15 pound, neutered, male, Russian Blue feline, in unknown condition, with concomitant skin allergies, was administered 1 tube of Advantage II Large Cat (Imidacloprid-Pyriproxyfen) topically by the owner. On an unspecified date post application, in approximately Feb-2017, the cat exhibited pruritus. On 23-Feb-2017, the owner administered 1 tube of Advantage II Large Cat (Imidacloprid-Pyriproxyfen) topically. Approximately 6 hours post application, the cat exhibited loose stools, 4 episodes of vomiting, lethargy, and dilated pupils; the owner washed the application site with dish soap and water. On 24 Feb 2017, the cat exhibited abnormal behavior. The cat was seen by the veterinarian, weighed 7 pounds, was diagnosed with hypertension, and administered intravenous fluids. On 26 Feb 2017, the cat was re-examined by the veterinarian and administered unspecified antibiotic and unspecified blood pressure medication. On approximately 28Feb2017, the feline died; 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

Reported pruritus on other than the application site is not anticipated with topical product administration. If any, skin reaction would be localized at the application site. Time to onset unknown. Other causes (concomitant history of skin allergies) should be considered. Later reported loose stools, vomiting, and lethargy are unspecific and may have many potential causes. Time to onset short, though. Oral product uptake was not witnessed. Even with oral product exposure sign would not be expected, but rather salivation. Dilated pupils are not expected with appropriate topical product use. Weight loss, diagnosed hypertension and later reported death are not expected after topical product application as inconsistent with pharmaco-toxicological product profile and experience. Product has wide margin of safety. Oral LD50 in rat is 642 mg/kg BW. 24-fold overdosage tolerated by cats without showing any side effect. The cat was very old (20 years old), thus underlying age-related medical problems are quite likely. Some information (e.g. health status and necropsy results) is not available. Neverthless, considering the products pharmacological profile, a relation is considered unlikely, but due to limited information, the case was considered as unassessable.