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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2014-0798

2. Registrant Information.

Registrant Reference Number: 130153480

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.

04-NOV-13

5. Location of incident.

Country: UNITED STATES

Prov / State: PENNSYLVANIA

6. Date incident was first observed.

02-NOV-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. 2724-811-270

Product Name: Bio Spot Defense Flea And Tick Spot On For Small Dogs 13 to 31 lbs

  • Active Ingredient(s)
    • (S)-METHOPRENE
      • Guarantee/concentration 3.6 %
    • ETOFENPROX
      • Guarantee/concentration 30 %
    • PIPERONYL BUTOXIDE
      • Guarantee/concentration 5 %

7. b) Type of formulation.

Liquid

Application Information

8. Product was applied?

Yes

9. Application Rate.

3

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 November 2, 2013 the owner applied the product to the dog to prevent fleas. Unknown if vet consulted before use on geriatric dog.

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

Pomeranian

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

13.0

7. Weight (provide a range if necessary )

12.5

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

>15 min <=2 hrs / >15 min <=2 h

10. Time between exposure and onset of symptoms

>30 min <=2 hrs / >30 min <=2 h

11. List all symptoms

System

  • Gastrointestinal System
    • Symptom - Drooling
  • Nervous and Muscular Systems
    • Symptom - Trembling
    • Symptom - Recumbent
    • Symptom - Rigidity
    • Specify - Jaw Clamping
    • Symptom - Seizure
  • 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 the evening of November 2, 2013 the owner noticed that the dog was symptomatic. 5 minutes later the owner observed that the dog died. On November 4, 2013 the owner contacted the Animal Product Safety Service (APSS) to obtain help. The APSS veterinarian stated that Etofenprox is classified as both a pyrethroid-like insecticide and a non-ester pyrethroid that is safe to use on cats and dogs, and does not result in tremors or seizure activity that can be seen from other pyrethroids since it is structurally different. he APSS veterinarian said that oral exposures often result in hypersalivation, nausea, and possibly hiding because of the taste; some animals will hypersalivate due to just the odor of the product. The APSS veterinarian recommended that the owner have a necropsy done, as the body had been frozen and the owner expressed an interest, call her regular veterinarian to have the dog shipped for a necropsy, and have her regular veterinarian call for diagnostic forms for the necropsy.


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 not considered related to the clinical situation. A necropsy was eventually performed. On November 8, 2013 necropsy results were received. The necropsy results revealed that a foreign body (dog treat) was within the oropharynx and was completely obstructing the laryngeal opening; based on this finding, the cause of death was asphyxia (category: smothering) due to the oropharyngeal foreign body and the manner of death was accidental. The APSS veterinarian stated that asphyxia was considered to have a high likelihood of causing the clinical situation. On November 9, 2013 an APSS veterinarian called the owner to discuss the necropsy findings.