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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2017-0705

2. Registrant Information.

Registrant Reference Number: 2017KP007

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

Address: 2920 matheson BLVD

City: Mississauga

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.

18-SEP-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 18-Sep-2016, a 6.5 year old, 15.8 pound, neutered,female, American Shorthair feline, in good condition, with no known concomitant medical conditions, was administered 1tube 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

American Curl Shorthair

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

6.5

7. Weight (provide a range if necessary )

15.8

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

<=30 min / <=30 min

11. List all symptoms

System

  • General
    • Symptom - Lethargy
    • Symptom - Death
  • Gastrointestinal System
    • Symptom - Anorexia
  • General
    • Symptom - Hyperactivity
    • Symptom - Hiding
  • Skin
    • Symptom - Hair loss
    • Symptom - Erythema
    • Symptom - Bleeding
  • Gastrointestinal System
    • Symptom - Vomiting
  • Skin
    • Symptom - Pain
  • Gastrointestinal System
    • Symptom - Other
    • Specify - Digestive Tract Hemorrhage
    • Symptom - Inappropriate defecation
  • Skin
    • Symptom - Bruises
    • Symptom - Lesion
    • Specify - Application Site Lesion
  • Blood
    • Symptom - Anemia
    • Symptom - Thrombocytopenia
  • Respiratory System
    • Symptom - Pleural effusion
  • Gastrointestinal System
    • Symptom - Other
    • Specify - abdominal effusion
    • Symptom - Loss of appetite

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?

Yes

14. b) How long was the animal hospitalized?

Unknown

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

Immediately post application, the cat exhibited a behavior change of running around the house and hiding. Approximately 1 hours post application, the cat vomited once, then the vomiting resolved. She exhibited lethargy. On 21-Sep-2016, the cat developed application site alopecia, application site erythema, application site bleeding, application site mucopurulent discharge, application site pain and anorexia. On 23-Sep-2016, the cat exhibited application site scabbing. The anorexia resolved. She was not examined by a veterinarian and the remaining clinical signs continued. Follow up received on 8th Nov 2016: Immediately post application, the cat exhibited hyperactivity and hiding. Approximately 1 hours post application, the cat vomited once then exhibited lethargy. On 21-Sep-2016, the cat developed application site alopecia, application site erythema, application site bleeding, application site mucopurulent discharge, application site pain and anorexia. On 23-Sep-2016, the cat exhibited application site scabbing. The anorexia resolved; the other signs continued. On approximately 25 Sep 2016, the cat became lethargic and had a decreased appetite. On 27 Sep 2016, the cat had bloody stool outside the litter box. The cat was examined by a veterinarian and exhibited bruising and skin lesions on her lower abdominal/pelvic area. The cat was hospitalized; blood work was performed and reveled low packed cell volume (anemia), and decreased platelet count. A fecal was performed (results unknown). The veterinarian diagnosed plural effusion and ascites. A whole blood transfusion was performed, unspecified steroids and unspecified antibiotics were administered and the clinical signs continued. On 02 Oct 2016, the cat died. No known necropsy was performed. Follow up received on 8th Nov 2016: On approximately 25 Sep 2016, the cat had a decreased appetite.


To be determined by Registrant

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

Death

19. Provide supplemental information here

A behavioural response to product sensation or product smell may occur in particularly sensitive animals. Vomiting is an unspecific and may have many potential causes. Sign is not expected after topical product use and oral product uptake was not witnessed. Lethargy is likely consequence of vomiting. In individual cases, dermal reactions at the application site are possible in animals that are particularly sensitive. Would not expect application site bleeding, application site mucopurulent discharge and application site pain directly related to the product however, likely cat scratched or licked at site and caused skin lesions by self-trauma. Self-trauma may have aggravated the application site reactions. Anorexia, lethargy and decreased appetite are likely associated with application site reactions. Bloody stools are neither expected nor inline with products pharmaco-toxicological profile. Later diagnosed abnormal blood parameters, plural effusion and ascites are neither expected nor inline with products pharmaco-toxicological profile. Death is inconsistent with pharmaco-toxicological product profile and experience. No signs of allergic/anaphylactic reaction reported. 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. Time to onset is short for behavioural signs, vomiting and application site reactions, however it is long for other signs. Finally, even though some information (e.g. necropsy results) missing, considering the most prominent sign death which characterizes this case, no plausible connection can be made to the product and a product relation is deemed to be unlikely.