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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2013-2846

2. Registrant Information.

Registrant Reference Number: 130004552

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.

11-JAN-13

5. Location of incident.

Country: UNITED STATES

Prov / State: FLORIDA

6. Date incident was first observed.

11-JAN-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. 2724-504-270

Product Name: Adams Spot On Flea And Tick Control For Cats 5 Lbs And Over

  • Active Ingredient(s)
    • (S)-METHOPRENE
      • Guarantee/concentration 3.6 %
    • ETOFENPROX
      • Guarantee/concentration 40 %

7. b) Type of formulation.

Liquid

Application Information

8. Product was applied?

Yes

9. Application Rate.

1.8

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 January 10, 2013 the owner applied the product to the cat to treat for ticks.

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 Shorthair

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

2.5

7. Weight (provide a range if necessary )

8.0

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

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

10. Time between exposure and onset of symptoms

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

11. List all symptoms

System

  • General
    • Symptom - Death
  • Gastrointestinal System
    • Symptom - Other
    • Specify - mild catarrhal gastroenteritis
  • General
    • Symptom - Parasitism
    • Specify - intralesional ascarids in the stomach and small intestine.

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 January 11, 2013 the owner found the pet deceased in her yard. A short time later, the owner contacted the Animal Product Safety Service (APSS) to obtain help. The APSS veterinarian stated that the ingredients in the product have a good margin of safety in cats and significant systemic signs would not be expected. The APSS veterinarian said that death would not be expected from a dermal application of the product. The APSS veterinarian recommended that the owner take the cat's body to the veterinarian for a necropsy, have the veterinarian call for information, and call back with questions.


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. Later on January 11, 2013 vet staff from the owner's regular veterinarian contacted the APSS to discuss a necropsy. The APSS veterinarian faxed over necropsy instructions. Later that afternoon an APSS technician called the owner's regular veterinary staff to discuss the necropsy. On January 15, 2013 the APSS technician contacted the vet staff to verify the cat's body had been submitted for necropsy. On January 17, 2013 interim necropsy results were received. The results revealed mild catarrhal gastroenteritis with intralesional ascarids in the stomach and small intestine. The gross examination failed to reveal the cause of the cat's death, and a histopathology was in progress. Final necropsy results are pending.