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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2013-6500

2. Registrant Information.

Registrant Reference Number: 130117462

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.

22-AUG-13

5. Location of incident.

Country: UNITED STATES

Prov / State: VIRGINIA

6. Date incident was first observed.

21-AUG-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 And Kittens Under 5 Lbs

  • 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

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 August 20, 2013 the owner inappropriately applied the product to the under labelled aged, debilitated kitten to treat for fleas.

To be determined by Registrant

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

No

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 )

0.10

7. Weight (provide a range if necessary )

1.0

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

>24 hrs <=3 days / >24 h <=3 jours

10. Time between exposure and onset of symptoms

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

11. List all symptoms

System

  • Gastrointestinal System
    • Symptom - Anorexia
  • Nervous and Muscular Systems
    • Symptom - Ataxia
    • Symptom - Difficulty getting up
    • Specify - Inability to Stand
    • Symptom - Unresponsive
    • Specify - Stupor
  • 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 August 21, 2013 the owner noticed that the kitten was symptomatic. That night, the owner's friend bathed the kitten with either liquid dish washing detergent (LDWD) or a kitten shampoo. On the morning of August 22, 2013 the owner noticed that the kitten was unable to stand; she was not curling her legs up when she was scruffed, either. At that time the owner also noticed that the kitten appeared to be in a stupor, letting her head fall in a water bowl and seeming unable to do any "tracking" with her eyes. A short time later that morning the owner contacted the Animal Product Safety Service (APSS) to obtain help. The APSS veterinarian stated that Etofenprox is a non-ester pyrethroid with a mechanism of action (MOA) similar to other pyrethroids. The APSS technician recommended that the owner take the kitten to the veterinarian and have the veterinarian call for information.


To be determined by Registrant

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

Death

19. Provide supplemental information here

On August 23, 2013 the owner called the APSS to update the case. The owner stated that the kitten died on the way to the veterinarian on August 22, 2013, about an hour or so after the initial consultation with the APSS. The APSS veterinarian suspected that there were probably a number of factors that could have contributed to the kitten's death, such as inappropriate use, ticks, age, and size. A necropsy was not available to determine the precise cause of death. Extra Label Use: Use on under aged kitten that was covered in ticks.