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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2013-6299

2. Registrant Information.

Registrant Reference Number: 2013CK070

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.

21-OCT-13

5. Location of incident.

Country: UNITED STATES

Prov / State: UNKNOWN

6. Date incident was first observed.

07-JUL-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. 11556-143

Product Name: K9 Advantix II Medium Dog

  • Active Ingredient(s)
    • IMIDACLOPRID
      • Guarantee/concentration 8.8 %
    • PERMETHRIN
      • Guarantee/concentration 44 %
    • PYRIPROXYFEN
      • Guarantee/concentration .44 %

7. b) Type of formulation.

Liquid

Application Information

8. Product was applied?

Yes

9. Application Rate.

1

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 07-Jul-2013,the dog was administered 1 tube of K9 Advantix II Medium Dog (Imidacloprid-Permethrin-Pyriproxyfen) once topically by the owner.

To be determined by Registrant

12. In your opinion, was the product used according to the label instructions?

Unknown

Subform III: Domestic Animal Incident Report

1. Source of Report

Animal's Owner

2. Type of animal affected

Dog / Chien

3. Breed

Cross breed

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

7

7. Weight (provide a range if necessary )

18.6

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 - Death
  • Skin
    • Symptom - Pruritus
  • Nervous and Muscular Systems
    • Symptom - Agitation
  • Skin
    • Symptom - Pale mucous membrane colour
  • Respiratory System
    • Symptom - Respiratory congestion
    • Specify - pulmonary congestion
    • Symptom - Pulmonary edema
  • Cardiovascular System
    • Symptom - Other
    • Specify - cardiomegaly
    • Symptom - Other
    • Specify - epicardial and myocardial pallor
  • Gastrointestinal System
    • Symptom -
    • Specify - abdominal cavity: mild serosanguineous effusion
  • Liver
    • Symptom - Hepatomegaly
  • Cardiovascular System
    • Symptom - Other
    • Specify - left atrioventricular endocardiosis
    • Symptom - Other
    • Specify - cardiomyopathy
  • Nervous and Muscular Systems
    • Symptom - Collapse

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?

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

On 18 Jun 2013 a 7 year old, 18.6 pound female, mixed breed canine in good condition was seen by the veterinarian for a mass removal on the mammary gland. During the mass removal a routine spay was performed. The mass was a benign mammary adenoma. On 07-Jul-2013,the dog was administered 1 tube of K9 Advantix II Medium Dog (Imidacloprid Permethrin Pyriproxyfen) once topically by the owner. Thirty minutes after product application the dog developed application site pruritus and agitation. On 09 Jul 2013 the dog was being bathed. During the bath she developed pale mucous membranes and collapsed. The dog was taken to the emergency clinic and was pronounced dead on arrival. Attempts to resuscitate were not successful. The dog has been sent to Purdue University for necropsy. A preliminary necropsy report was recieved on 12 Jul 2013. Gross examination revealed the following findings Lungs Pulmonary congestion and edema Heart Cariomegaly, left atrioventricular valve endocardiosis, focal epicardial and myocardial pallor Abdominal cavity Mild serosanguineous effesion Liver hepatomegtaly Abdominal wall Multifocal subcuataneous and intramuscular hemorrhage. A definitive cause of the reported clinical signs and death in this dog could not be determined on gross examination. Histopathology, bacteriology and virology are currently pending. On 15 Jul 2013 the first results from the bacteriology were positive for E. coli, Clostridium perfringens and Clostridium bifermentans in the intestines. Virus isolation is currently pending from the intestines, lungs and tongue. Follow-up on 26 Jul 2013: 26 Jul 2013 The results of the necropsy revealed chronic cardiomyopathy and left atrioventricular endocardititis. Comments on Diagnosis Gross and histologic findings are consistent with chronic cardiomyopathy with cardiac enlargement, mycordial fibrosis and necrosis. Cardiac disease is a potential cause of sudden death in canines. The definitive cause of the myocardial changes is unknown; however, the chronic nature of the histiological changes indicates long standing myocardial disease that was not caused by the reported recent antiparasitic treatment. The histologic lesions in the kidney also represent chronic changes that may be related to chronic cardiovascular disease. No more information is expected. Case is closed. NOTE the dog had presented application site pruritus and agitation after a previous application of Advantix.


To be determined by Registrant

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

Death

19. Provide supplemental information here

Reported application site pruritus and agitation may reflect paraesthesia caused by permethrin, shortly after application of product. These early signs and their time to onset are consistent. However, death not expected in dog after product application, as inconsistent with pharmaco-toxicological product profile. No signs of allergy/anaphylactic reaction reported. As time to onset to death was 2 days, allergic/anaphylactic reaction can be excluded. Other etiologies more probable, in particular as dog had recent history of neoplasm and surgery. Necropsy revealed chronic myocardial disorder and renal disorder, deemed to be responsible for dogs death. Considering all aspects, product connection is unlikely.