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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2017-4598

2. Registrant Information.

Registrant Reference Number: 170110637

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.

30-JUN-17

5. Location of incident.

Country: UNITED STATES

Prov / State: INDIANA

6. Date incident was first observed.

30-JUN-17

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. 2724-813-89459

Product Name: Bio Spot Active Care Flea And Tick Spot On 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 June 30, 2017 the owner applied the product to the geriatric cat as prevention.

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

Domestic Unspecified

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

28.0

7. Weight (provide a range if necessary )

17.5

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

<=15 min / <=15 min

10. Time between exposure and onset of symptoms

<=30 min / <=30 min

11. List all symptoms

System

  • Gastrointestinal System
    • Symptom - Vomiting
  • Nervous and Muscular Systems
    • Symptom - Ataxia
    • Symptom - Disorientation
  • Skin
    • Symptom - Other
    • Specify - Dermal Hypersensitivity
    • Symptom - Other
    • Specify - Application Site Hemorrhage
  • 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

Shortly after the product was applied on June 30, 2017 the cat developed symptoms. The owner then bathed the cat with liquid dish washing detergent and water. The owner noticed that the cat had developed an application site hemorrhage during the bath. The owner then contacted the Animal Product Safety Service (APSS) and the APSS technician stated that etofenprox is in the pyrethroid family and is safe to use on cats. The APSS technician also stated that it does not result in tremors or seizure activity that can be seen from other pyrethroids, since it is structurally different. The APSS technician also stated that dermal exposures may cause mild dermal irritation and hyperesthesia within the first 24-48 hours, possibly secondary alopecia from pruritus, and that oral exposures often result in hypersalivation, nausea, and possibly hiding because of the taste. The APSS technician continued by stating that some animals will hypersalivate just from the odor of the product. The APSS technician also stated that (s)- methoprene is an insect growth regulator (IGR) that disrupts the reproductive cycles of fleas, has low mammalian toxicity, may cause mild dermal irritation or sensitivity, usually from the carriers in the product, and that if ingested, there could be hypersalivation and nausea. The APSS assistant recommended the owner take the animal to a veterinarian, have the veterinarian call for information, and to 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

On July 17, 2017 the owner called the APSS to update the case. The owner stated that the cat was not taken to a veterinarian, never recovered, and passed away that morning. A necropsy was declined as the cat had already been buried. It is unknown if the owner consulted a veterinarian about using the product on this geriatric cat.