Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2016-0029

2. Registrant Information.

Registrant Reference Number: 150129886

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.

20-SEP-15

5. Location of incident.

Country: CANADA

Prov / State: NOVA SCOTIA

6. Date incident was first observed.

19-SEP-15

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)

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PMRA Registration No. 31367      PMRA Submission No.       EPA Registration No.

Product Name: Zodiac Powerspot With Smart Shield Flea And Tick Control for Dogs

• Active Ingredient(s)
  • (S)-METHOPRENE
  • PERMETHRIN

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7. b) Type of formulation.

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 September 19, 2015 the owner applied the product onto the two dogs as prevention.

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

Dog / Chien

3. Breed

Chihuahua

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

8.0

7. Weight (provide a range if necessary )

15.0

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

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

11. List all symptoms

System

• Nervous and Muscular Systems
  • Symptom - Restlessness
  • Symptom - Shaking
  • Specify - Paw Shaking
  • Symptom - Agitation

• General
  • Symptom - Abnormal behaviour
  • Specify - Behavior Change
  • Symptom - Sleepiness

12. How long did the symptoms last?

Unknown / Inconnu

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

Unknown/Inconnu

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 19, 2015 the dog developed symptoms. On September 20, 2015 the owner contacted the Animal Product Safety Service (APSS). The APSS technician stated permethrins and pyrethroids can cause a tingling sensation to the skin. The APSS technician also stated some animals are more sensitive to the ingredients than others, and may experience rolling, hiding, vocalization, clingy behavior, lethargy, panting, reluctance to move, or have an abnormal gait (take a few steps, stop, sit down and turn quickly toward their tail). The APSS technician further stated signs often resolve after bathing and with topical applications of vitamin E and cool compresses, but may take up to 24-72 hours. The APSS technician recommended bathing (with mild dish soap and lukewarm water; towel dry and keep warm), vitamin E (puncture vitamin E capsule and apply the oil to the site of the application), monitor at home (for current signs, if they do not start improving after implemented cares, call back), call back with questions, and discontinue product usage (do not use products that contain permethrin in the future).

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To be determined by Registrant

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

Minor

19. Provide supplemental information here

Signs were expected to be mild and self limiting. On September 21, 2015 the owner contacted APSS and said the dogs are not improving (they did sleep last night, but they are still scratching at the application sites (skin looks within normal limits (wnl)) and kicking/jerking back legs when walking. The APSS veterinarian recommended another bath with liquid dish washing detergent (LDWD) and another application of vitamin E. The APSS veterinarian also discussed that Benadryl can be tried but the owner elected to try bathing and vitamin E first so the doses for Benadryl were not discussed, but it was specified they need to make sure there is no decongestant.

Subform III: Domestic Animal Incident Report

1. Source of Report

Animal's Owner

2. Type of animal affected

Dog / Chien

3. Breed

Miniature Pinscher

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

3.0

7. Weight (provide a range if necessary )

10.0

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

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

11. List all symptoms

System

• Nervous and Muscular Systems
  • Symptom - Restlessness
  • Symptom - Shaking
  • Specify - Paw Shaking
  • Symptom - Agitation

• General
  • Symptom - Abnormal behaviour
  • Specify - Behavior Change

12. How long did the symptoms last?

Unknown / Inconnu

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

Unknown/Inconnu

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 19, 2015 the dog developed symptoms. On September 20, 2015 the owner contacted the Animal Product Safety Service (APSS). The APSS technician stated permethrins and pyrethroids can cause a tingling sensation to the skin. The APSS technician also stated some animals are more sensitive to the ingredients than others, and may experience rolling, hiding, vocalization, clingy behavior, lethargy, panting, reluctance to move, or have an abnormal gait (take a few steps, stop, sit down and turn quickly toward their tail). The APSS technician further stated signs often resolve after bathing and with topical applications of vitamin E and cool compresses, but may take up to 24-72 hours. The APSS technician recommended bathing (with mild dish soap and lukewarm water; towel dry and keep warm), vitamin E (puncture vitamin E capsule and apply the oil to the site of the application), monitor at home (for current signs, if they do not start improving after implemented cares, call back), call back with questions, and discontinue product usage (do not use products that contain permethrin in the future).

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To be determined by Registrant

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

Minor

19. Provide supplemental information here

Signs were expected to be mild and self limiting. On September 21, 2015 the owner contacted APSS and said the dogs are not improving (they did sleep last night, but they are still scratching at the application sites (skin looks within normal limits (wnl)) and kicking/jerking back legs when walking. The APSS veterinarian recommended another bath with liquid dish washing detergent (LDWD) and another application of vitamin E. The APSS veterinarian also discussed that Benadryl can be tried but the owner elected to try bathing and vitamin E first so the doses for Benadryl were not discussed, but it was specified they need to make sure there is no decongestant.