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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2016-7526

2. Registrant Information.

Registrant Reference Number: 160145560

Registrant Name (Full Legal Name no abbreviations): Wellmark International

Address: 100 Stone Road West, Suite 111

City: Guelph

Prov / State: Ontario

Country: Canada

Postal Code: N1G5L3

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

Domestic Animal

4. Date registrant was first informed of the incident.

29-SEP-16

5. Location of incident.

Country: UNITED STATES

Prov / State: MISSOURI

6. Date incident was first observed.

28-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. 2724-803-270

Product Name: Adams Flea and Tick Spray for Dogs and Cats

  • Active Ingredient(s)
    • (S)-METHOPRENE
      • Guarantee/concentration .1 %
    • ETOFENPROX
      • Guarantee/concentration .25 %
    • PIPERONYL BUTOXIDE
      • Guarantee/concentration .75 %

7. b) Type of formulation.

Liquid

Application Information

8. Product was applied?

Yes

9. Application Rate.

Unknown

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 September 28, 2016 the owner applied the product onto the cat to treat condition.

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

Cat / Chat

3. Breed

Siamese

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

5.0

7. Weight (provide a range if necessary )

12.0

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

>2 hrs <=8 hrs / >2 h <=8 h

10. Time between exposure and onset of symptoms

Unknown / Inconnu

11. List all symptoms

System

  • Nervous and Muscular Systems
    • Symptom - Head shaking
  • General
    • Symptom - Death

12. How long did the symptoms last?

Persisted until death

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

No

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 September 28, 2016 the cat developed head shaking. That evening, the owner bathed the cat (liquid dish washing detergent (LDWD)). On September 29, 2016 the owner found the cat dead in the morning. The owner then contacted the Animal Product Safety Service (APSS). The APSS veterinarian stated we would not expect death as a direct result of the product use. The APSS veterinarian recommended a necropsy. The APSS veterinarian discussed with the owner taking the cat's body to the veterinary clinic for necropsy submission and having the veterinary clinic call for information regarding instructions. Later that morning, the attending veterinarian called the APSS to discuss necropsy submission instructions.


To be determined by Registrant

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

Death

19. Provide supplemental information here

The APSS veterinarian stated that the substance was considered to have a doubtful likelihood of causing the clinical situation. On October 4, 2016 the attending veterinarian called the APSS to state she had received a copy of the necropsy results. The gross necropsy report revealed the following morphologic diagnosis: heart (left ventricle) showed mild concentric hypertropy; lung showed diffuse, moderate edema; liver showed diffuse, moderate congestion; urinary bladder showed multifocal to coalescing, moderate, acute cystitis (presumptive); small intestine (jejunum) showed mild tapeworm parasitism; pancreas showed multifocal to coalescing, mild, acute pancreatitis; and right eye showed mild hyphema. Gross lesions observed in this animal were unspecific and a cause of death could not be determined. The histopath necropsy report revealed a morphologic diagnosis: the heart (left ventricle and interventricular septum) showed multifocal, moderate, myocardial disarray and fibrosis; the lung showed multifocal to coalescing, moderate, histiocytic interstitial pneumonia with type II pneumocyte hyperplasia and smooth muscle hypertrophy and hyperplasia. The histopathologic findings are highly suggestive of a chronic cardiac disease consistent with feline hypertrophic cardiomyopathy. Furthermore, pulmonary lesions were also characterized by a chronic process of unknown cause. It is uncertain, however, if the observed alterations elicited clinical abnormalities that contributed to the cause of death of this animal. Gross lesions observed in the urinary bladder and pancreas represented alterations of minimal significance on microscopic examination. Shortly after reviewing the report, the APSS veterinarian called the attending veterinarian back to discuss the necropsy and stated it was okay to give the owner a copy of the report. The APSS veterinarian also stated she would call the owner to discuss the necropsy results. The APSS veterinarian called the owner to go over the results and stated that it was highly suggestive of a chronic cardiac disease consistent with feline hypertrophic cardiomyopathy. The APSS veterinarian also stated the report revealed pulmonary lesions characterized by a chronic process of unknown cause. The APSS veterinarian discussed that underlying disease contributed to the death of the cat, spraying of the product may have been a trigger. The owner requested a copy of the necropsy report. The APSS veterinarian stated she was unable to mail a copy, but a copy could be obtained from the attending veterinary clinic. The APSS veterinarian called the attending veterinary clinic to let them know that the owner was interested in obtaining a copy of the necropsy results. The APSS veterinarian stated that hypertropic cardiomyopathy was considered to have a high likelihood of causing the clinical situation.