Health Canada
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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2011-3641

2. Registrant Information.

Registrant Reference Number: 2011-CA-00871

Registrant Name (Full Legal Name no abbreviations): Merck Animal Health (Intervet Canada Corp)

Address: 16750 Transcanada Highway

City: Kirkland

Prov / State: Quebec

Country: Canada

Postal Code: H9H 4M7

3. Select the appropriate subform(s) for the incident.

Domestic Animal

4. Date registrant was first informed of the incident.

29-JUL-11

5. Location of incident.

Country: CANADA

Prov / State: NOVA SCOTIA

6. Date incident was first observed.

12-JUL-11

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. 773-73

Product Name: Defend

  • Active Ingredient(s)
    • PERMETHRIN

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).

Suspect lack of efficacy was reported by the pet owner. The owner applied 1 ml of the Defend to her dog's back on 21 July 2011 and still see many fleas on it's body. The pet was scratching prior to treatment and continues to scratch. The dog has not been washed or in the rain since application. The owner has used this product on other pets in the past successfully. The case is closed.

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

Medical Professional

2. Type of animal affected

Dog / Chien

3. Breed

Border Collie

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

11.0

7. Weight (provide a range if necessary )

50.0

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

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

11. List all symptoms

System

  • Skin
    • Symptom - Pruritus
  • General
    • Symptom - Parasitism

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.

No

14. a) Was the animal hospitalized?

No

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

Possible lack of efficacy reported by the pet owner. A pet owner has applied Defend to her 4 dogs on 12 July 2011, 3 of the dogs weighing between 9 and 18 pounds received 1 ml applied topically to the back and the dog weighing 50 pounds received 2 ml. The owner uses the product as a prevention. The dogs have been scratching all over since the use of the product, she not sure if the dogs had fleas prior to the treatment. A few days prior to application, the dogs were also in contact with a relative's dog that does have fleas and used Defend, and reported a possible lack of efficacy also. Upon further questioning of the client, it is undetermined if her pets had fleas prior to treatment and whether or not they were scratching prior to the treatment. She was advised to visit her regular veterinarian and have her pets examined. The product was not purchased from her small animal clinic, rather a local large animal clinic. The case is closed.


To be determined by Registrant

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

Minor

19. Provide supplemental information here

Subform III: Domestic Animal Incident Report

1. Source of Report

Medical Professional

2. Type of animal affected

Dog / Chien

3. Breed

Miniature Dachshund

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

5

7. Weight (provide a range if necessary )

18.0

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

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

11. List all symptoms

System

  • General
    • Symptom - Parasitism
  • Skin
    • 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.

No

14. a) Was the animal hospitalized?

No

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

Possible lack of efficacy reported by the pet owner. A pet owner has applied Defend to her 4 dogs on 12 July 2011, 3 of the dogs weighing between 9 and 18 pounds received 1 ml applied topically to the back and the dog weighing 50 pounds received 2 ml. The owner uses the product as a prevention. The dogs have been scratching all over since the use of the product, she not sure if the dogs had fleas prior to the treatment. A few days prior to application, the dogs were also in contact with a relative's dog that does have fleas and used Defend, and reported a possible lack of efficacy also. Upon further questioning of the client, it is undetermined if her pets had fleas prior to treatment and whether or not they were scratching prior to the treatment. She was advised to visit her regular veterinarian and have her pets examined. The product was not purchased from her small animal clinic, rather a local large animal clinic. The case is closed.


To be determined by Registrant

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

Minor

19. Provide supplemental information here

Subform III: Domestic Animal Incident Report

1. Source of Report

Medical Professional

2. Type of animal affected

Dog / Chien

3. Breed

Miniature Dachshund

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

2

7. Weight (provide a range if necessary )

15.0

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

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

11. List all symptoms

System

  • General
    • Symptom - Parasitism
  • Skin
    • 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.

No

14. a) Was the animal hospitalized?

No

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

Possible lack of efficacy reported by the pet owner. A pet owner has applied Defend to her 4 dogs on 12 July 2011, 3 of the dogs weighing between 9 and 18 pounds received 1 ml applied topically to the back and the dog weighing 50 pounds received 2 ml. The owner uses the product as a prevention. The dogs have been scratching all over since the use of the product, she not sure if the dogs had fleas prior to the treatment. A few days prior to application, the dogs were also in contact with a relative's dog that does have fleas and used Defend, and reported a possible lack of efficacy also. Upon further questioning of the client, it is undetermined if her pets had fleas prior to treatment and whether or not they were scratching prior to the treatment. She was advised to visit her regular veterinarian and have her pets examined. The product was not purchased from her small animal clinic, rather a local large animal clinic. The case is closed.


To be determined by Registrant

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

Minor

19. Provide supplemental information here

Subform III: Domestic Animal Incident Report

1. Source of Report

Medical Professional

2. Type of animal affected

Dog / Chien

3. Breed

Miniature Dachshund

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

9

7. Weight (provide a range if necessary )

9.0

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

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

11. List all symptoms

System

  • General
    • Symptom - Parasitism
  • Skin
    • Symptom - Pruritus

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.

No

14. a) Was the animal hospitalized?

No

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

Possible lack of efficacy reported by the pet owner. A pet owner has applied Defend to her 4 dogs on 12 July 2011, 3 of the dogs weighing between 9 and 18 pounds received 1 ml applied topically to the back and the dog weighing 50 pounds received 2 ml. The owner uses the product as a prevention. The dogs have been scratching all over since the use of the product, she not sure if the dogs had fleas prior to the treatment. A few days prior to application, the dogs were also in contact with a relative's dog that does have fleas and used Defend, and reported a possible lack of efficacy also. Upon further questioning of the client, it is undetermined if her pets had fleas prior to treatment and whether or not they were scratching prior to the treatment. She was advised to visit her regular veterinarian and have her pets examined. The product was not purchased from her small animal clinic, rather a local large animal clinic. The case is closed.


To be determined by Registrant

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

Minor

19. Provide supplemental information here