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: 2019-4466

2. Registrant Information.

Registrant Reference Number: USA-BAYERBAH-2019-US0043577 (Report 586098)

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.

29-JUL-19

5. Location of incident.

Country: UNITED STATES

Prov / State: WASHINGTON

6. Date incident was first observed.

25-JUL-19

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.

Other (specify)

spot on

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 approximately 25-Jul-2019, a 6 year old, 11 pound, male, Domestic cat, of unknown reproductive status, in unknown condition, with the concomitant medical conditions of ongoing weight loss and fleas, was administered 1 tube of Advantage II Large Cat (Imidacloprid-Pyriproxyfen) via the topical route by the animal 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

Domestic

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

6

7. Weight (provide a range if necessary )

4.99

kg

8. Route(s) of exposure

Skin

9. What was the length of exposure?

>3 days <=1 wk / >3 jours <=1 sem

10. Time between exposure and onset of symptoms

>8 hrs <=24 hrs / > 8 h < = 24 h

11. List all symptoms

System

  • General
    • Symptom - Lethargy
  • Gastrointestinal System
    • Symptom - Anorexia
  • General
    • Symptom - Adipsia
  • Renal System
    • Symptom - Anuria
  • Gastrointestinal System
    • Symptom - Constipation
  • General
    • Symptom - Death
  • Eye
    • Symptom - Other
    • Specify - Palpebral disorder NOS
  • Nervous and Muscular Systems
    • Symptom - Other
    • Specify - Muscle wasting
  • Gastrointestinal System
    • Symptom - Other
    • Specify - Pancreas disorder
  • Renal System
    • Symptom - Other
    • Specify - Renal disorder NOS
  • Cardiovascular System
    • Symptom - Other
    • Specify - Cardiac disorder NOS
    • Symptom - Other
    • Specify - Cardiomyopathy
    • Symptom - Other
    • Specify - Cardiac enlargement
  • Skin
    • Symptom - Other
    • Specify - Erythemato-squamous condition
  • Liver
    • Symptom - Other
    • Specify - NT - hepatic lipidosis (steatosis)
  • Gastrointestinal System
    • Symptom - Other
    • Specify - Intestinal disorder NOS

12. How long did the symptoms last?

Unknown / Inconnu

13. Was medical treatment provided? Provide details in question 17.

Unknown

14. a) Was the animal hospitalized?

Unknown

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 12 hours post application, the cat developed lethargy. On approximately 26-Jul-2019, the cat developed anorexia, adipsia, anuria, and constipation. The cat also had a slow blink reflex (palpebral disorder nos). No medical intervention was sought. On 29-Jul-2019, the cat died and no known necropsy was performed. No more information is expected and this case is closed. Follow up received on 5th Aug 2019: On 29-Jul-2019, the cat died. On 02 Aug 2019, necropsy was performed at a diagnostic lab. The preliminary results showed body condition score was poor based on scant adipose tissue stores and reduced skeletal muscle mass. Both pancreas lobes had multiple circular firm raised smooth nodules. There were approximately 10 pinpoint pale tan foci within the left renal papilla. The heart weighed 22 grams. The left ventricular free wall thickness was 0.7 cm, and the right ventricular free wall thickness was 0.2 cm. Gross diagnosis was presumptive moderate hypertrophic cardiomyopathy, moderate multifocal pancreatic nodular hyperplasia, and presumptive mild multifocal mineralization of the left renal papilla. The pathologist commented that the cardiomegaly and subjectively thickened left ventricle are highly suggestive of hypertrophic cardiomegaly and may have contributed to the cat's abrupt and unexpected death. The changes in the pancreas and kidney are likely incidental age-related changes unrelated to the overall disease process. Follow up received on 5th Aug 2019: Interim histopathology results were acute moderate centrilobular to midzonal hepatic lipidosis, chonic moderate multifocal proteinosis and chonic moderate multifocal nephrocalcinosis of the renal medulla, chronic mild hypertrophic cardiomyopathy, chronic mild miltifocal lymphocytic perivasculitis of the pancreas, and chronic moderate multifocal crypt abscess in the small intestine. The pathologist commented thet the most likely cause of death was hepatic lipidosis. The changes in the kidney were consistent with chronic renal diease. The structural changes in the heart were highly suggestive of hypertrophic cardiomyopathy. Although cardiomyopathy can cause sudden death in cats, the changes were mild and may represent an incidental finding.


To be determined by Registrant

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

Death

19. Provide supplemental information here

O - Unclassifiable/unassessable Reported systemic signs are unspecific and may have numerous other causes. Anuria and slow blink reflex are not expected after appropriate product application. Ocular product exposure is not reported. Additionally, reported constipation is not expected with appropriate topical product use. No oral product exposure witnessed and no signs indicating product uptake such as salivation or vomiting seen. Time to onset is consistent. Death is 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. Fetal outcome in this case is likely due to cardiomyopathy and hepatic lipidosis. Time to onset is long. Further necropsy findings including gross and histopathological findings are not expected after appropriate topical product application as inconsistent with product's pharmaco-toxicological profile. The changes in the pancreas and kidney are likely incidental age-related changes. Overall, a product involvement is unassessable.