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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2016-0034

2. Registrant Information.

Registrant Reference Number: 150114344

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-AUG-15

5. Location of incident.

Country: CANADA

Prov / State: ONTARIO

6. Date incident was first observed.

13-AUG-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)

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

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

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

PMRA Registration No. 31366      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

PMRA Registration No. 31368      PMRA Submission No.       EPA Registration No.

Product Name: Zodiac Spot On II With Smart Shield Flea Control For Cats And Kittens

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

7. b) Type of formulation.

Application Information

8. Product was applied?

Yes

9. Application Rate.

Unknown

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).

Starting on July 13, 2015 and continuing monthly until August 13, 2015 the owner applied the products onto the two dogs and the cat.

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

Great Pyrenees

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

6.0

7. Weight (provide a range if necessary )

150.0

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

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

11. List all symptoms

System

  • Gastrointestinal System
    • Symptom - Diarrhea
  • General
    • Symptom - Lethargy
  • Skin
    • Symptom - Erythema

12. How long did the symptoms last?

>1 wk <=1 mo / > 1 sem < = 1 mois

13. Was medical treatment provided? Provide details in question 17.

Unknown

14. a) Was the animal hospitalized?

Unknown

14. b) How long was the animal hospitalized?

15. Outcome of the incident

Fully Recovered / Complètement rétabli

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 14, 2015 the dog developed diarrhea, lethargy, and erythema. On August 16, 2015 the owner bathed the dog (with flea and tick shampoo) and fed the dog a bland diet (fed boiled beef and rice), the erythema became mild. On August 18, 2015 the dog's diarrhea and lethargy ended. On August 20, 2015 the owner contacted the Animal Product Safety Service (APSS) and during the call stated the dog's erythema had resolved and he was back to normal, aside from the fleas. The APSS veterinarian stated if this product was ingested, mild self limiting gastrointestinal (GI) upset or a taste reaction/drooling would be expected. The APSS veterinarian also stated dermal paraesthesia (hiding, pruritus, behavior changes) is also possible and dermal decontamination (done prior to call) is advised. The APSS veterinarian further stated permethrin, a type 1 pyrethroid insecticide, alters the voltage-dependent gating kinetics of the sodium channels of nervous tissue and this reversible prolongation of sodium conductance in nerve axons results in repetitive nerve discharges. The APSS veterinarian recommended flea treatment (under the advice of regular veterinarian, use different flea product, be sure to treat the house as well) and taking the dog to the veterinarian (for exam and flea treatment).


To be determined by Registrant

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

Minor

19. Provide supplemental information here

No significant signs were expected.

Subform III: Domestic Animal Incident Report

1. Source of Report

Animal's Owner

2. Type of animal affected

Cat / Chat

3. Breed

Domestic Longhair

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

5.0

7. Weight (provide a range if necessary )

6.0

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

<=30 min / <=30 min

11. List all symptoms

System

  • Gastrointestinal System
    • Symptom - Vomiting
  • General
    • Symptom - Subdued

12. How long did the symptoms last?

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

13. Was medical treatment provided? Provide details in question 17.

Unknown

14. a) Was the animal hospitalized?

Unknown

14. b) How long was the animal hospitalized?

15. Outcome of the incident

Fully Recovered / Complètement rétabli

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 13, 2015 the cat started vomiting and became subdued. The vomiting ended the evening of August 13, 2015 while the cat was no longer subdued on August 14, 2015. On August 20, 2015 the owner contacted the Animal Product Safety Service (APSS). The APSS veterinarian stated mild and self limiting gastrointestinal (GI) upset and mild lethargy are possible especially after cats groom the topical product off and ingest it. The APSS veterinarian also stated further symptoms are not expected to develop. The APSS veterinarian stated furthermore s-methoprene is an insect growth regulator. The APSS veterinarian additionally stated dermal exposure could result in taste reactions. The APSS veterinarian stated as well, taste reactions typically occur within minutes and dermal hypersensitivity occurs within minutes to hours. The APSS veterinarian also stated oral exposures can lead to lethargy and rarely ataxia or tremors and adverse effects after oral administration appear within 2-8 hours post administration and appear to last 6-12 hours. The APSS veterinarian recommended taking the cat to the veterinarian (for exam and flea treatment) and a flea treatment (get recommendation on flea product from vet and do not forget to treat the house).


To be determined by Registrant

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

Minor

19. Provide supplemental information here

No significant signs were expected.

Subform III: Domestic Animal Incident Report

1. Source of Report

Animal's Owner

2. Type of animal affected

Dog / Chien

3. Breed

Lhasa Apso Mix

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

4.0

7. Weight (provide a range if necessary )

12.0

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

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

11. List all symptoms

System

  • Gastrointestinal System
    • Symptom - Vomiting
  • General
    • Symptom - Hiding
  • Skin
    • Symptom - Erythema
    • Symptom - Pruritus

12. How long did the symptoms last?

>3 days <=1 wk / >3 jours <=1 sem

13. Was medical treatment provided? Provide details in question 17.

Unknown

14. a) Was the animal hospitalized?

Unknown

14. b) How long was the animal hospitalized?

15. Outcome of the incident

Fully Recovered / Complètement rétabli

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 14, 2015 the dog developed vomiting, hiding, erythema, and pruritus. On August 16, 2015 the owner bathed the dog (with flea and tick shampoo) and fed the dog a bland diet (boiled beef and rice). On August 16, 2015 the dog's erythema and pruritus became mild. On August 18, 2015 the dog's vomiting and hiding ended. On August 20, 2015 the owner contacted the Animal Product Safety Service (APSS) and during the call stated the dog's erythema and pruritus had resolved and she was back to normal, aside from the fleas. The APSS veterinarian stated if this product was ingested, mild self limiting gastrointestinal (GI) upset or a taste reaction/drooling would be expected. The APSS veterinarian also stated dermal paraesthesia (hiding, pruritus, behavior changes) is also possible and dermal decontamination (done prior to call) is advised. The APSS veterinarian further stated permethrin, a type 1 pyrethroid insecticide, alters the voltage-dependent gating kinetics of the sodium channels of nervous tissue and this reversible prolongation of sodium conductance in nerve axons results in repetitive nerve discharges. The APSS veterinarian recommended flea treatment (under the advise of regular veterinarian, use different flea product, be sure to treat the house as well) and taking the dog to the veterinarian (for exam and flea treatment).


To be determined by Registrant

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

Minor

19. Provide supplemental information here

No significant signs were expected.