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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2012-1325

2. Registrant Information.

Registrant Reference Number: x

Registrant Name (Full Legal Name no abbreviations): x

Address: x

City: x

Prov / State: x

Country: x

Postal Code: X

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

Domestic Animal

4. Date registrant was first informed of the incident.

5. Location of incident.

Country: CANADA

Prov / State: ONTARIO

6. Date incident was first observed.

11-MAR-12

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. 26490      PMRA Submission No.       EPA Registration No.

Product Name: Hartz Ultraguard Plus Flea & Tick Drops for Dogs and Puppies over14kg

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

7. b) Type of formulation.

Application Information

8. Product was applied?

Yes

9. Application Rate.

2

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).

1 tube X 2ml each was used on dog. Spot on treatment (drops). Please note product was washed off after appr. 10 minutes of initial application.

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

Jack Russell\Poodle

4. Number of animals affected

1

5. Sex

Unknown

6. Age (provide a range if necessary )

Unknown

7. Weight (provide a range if necessary )

Unknown

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

Unknown / Inconnu

11. List all symptoms

System

  • Skin
    • Symptom - Irritated skin
    • Symptom - Red skin
    • Symptom - Rash

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.

Yes

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

Severe skin irritation (rash). Raw red skin all over body including inside ears, genitals. The neck area where product was applied is exceptionally irritated. So far there has been little improvement in condition and this is over a six day period. Veterinary was visited who prescripted Apo Cephalexin as well as Vanectyl-P.It was reported to the seller, a pet store franchise. Since taking the medication prescribed by the vet, the dogs skin has cleared. The pet store franchise when approached admitted knowing the harmful effects of this and similar products. They admitted they keep it on the shelf because consumers request it even though there are very harmful and substantial risks imposed to pets.


To be determined by Registrant

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

Not Applicable

19. Provide supplemental information here