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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2014-0513

2. Registrant Information.

Registrant Reference Number: 365191

Registrant Name (Full Legal Name no abbreviations): Hartz Canada Inc.

Address: 1125 Talbot Street

City: St. Thomas

Prov / State: ON

Country: Canada

Postal Code: N5P 3W7

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

Domestic Animal

4. Date registrant was first informed of the incident.

01-OCT-13

5. Location of incident.

Country: CANADA

Prov / State: ONTARIO

6. Date incident was first observed.

11-SEP-13

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. 29283      PMRA Submission No.       EPA Registration No.

Product Name: HARTZ ULTRAGUARD PRO FLEA AND TICK DROPS FOR DOGS AND PUPPIES WEIG

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

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).

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

Mixed Breed Dog

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

3

7. Weight (provide a range if necessary )

7.5

lbs

8. Route(s) of exposure

Unknown

9. What was the length of exposure?

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

10. Time between exposure and onset of symptoms

>30 min <=2 hrs / >30 min <=2 h

11. List all symptoms

System

  • Nervous and Muscular Systems
    • Symptom - Seizure
    • Symptom - Paralysis
    • Symptom - Loss of coordination
    • Specify - falling over
  • Gastrointestinal System
    • Symptom - Loss of appetite
    • Symptom - Constipation
  • Renal System
    • Symptom - Painful urination
  • Gastrointestinal System
    • Symptom - Other
    • Specify - difficulty urinating
    • Symptom - Constipation
    • Specify - difficulty defecating
  • Skin
    • Symptom - Pruritus
  • Nervous and Muscular Systems
    • Symptom - Agitation
    • Symptom - Ataxia
    • Specify - hypometric gait
  • Eye
    • Symptom - Decreased pupillary light reflex
    • Specify - slow pupillary light reflexes
  • General
    • Symptom - Abnormal behaviour

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?

Yes

14. b) How long was the animal hospitalized?

5

Hour(s) / Heure(s)

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

Customer applied this product as a preventative measure against fleas and ticks. As directed, a treatment was administered topically between the shoulder blades with no noticeable effects, a month later as recommended, the second dosage was administered.


To be determined by Registrant

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

Moderate

19. Provide supplemental information here

Customer applied this product as a preventative measure against fleas and ticks. As directed, a treatment was administered topically between the shoulder blades with no noticeable effects, a month later as recommended, the second dosage was administered but this time the effects were immediate and violent. Within a few minutes the dog's behavior was drastically altered, and a downward spiralled to a trip to the veterinary hospital where he was immediately checked for poisoning. After a very long day of blood work,the administration of IV fluids, a bath and the application of vitamin E drops to attempt to stop the spread of the poison, the veterinarian deduced that his reaction was as a result of being administered a significantly excessive amount of the active ingredient. Dog was sent home after a day of treatment and advised that nothing more could be done and that we would need to wait it out and hope that the dog recovered. Over the course of the next 2 or 3 days where the dog often showed violent seizure like episodes, darting legs and falling over (in a paralyzed state). Other symptoms included, loss of appetite and difficulty defecating and urinating. After 1 week the dog recovered. Vet-examined dog on Thursday Sept 12, 2013. Dog received a dose of Hartz Ultraguard on Sept 11, 2013 apprx 6-7pm, and by 9-10 pm that evening he was showing signs of lethargy, unbalance, pruritis and agitation. The following morning he was not eating or drinking and was still off balance. On physical examination dog was lethargic, his abnormal neurologic signs included slow Pupillary light reflexes, he had a hypometric gait, was off balance and would occasionally fall over. Based on his physical exam and history of recent application of the Hartz product, his most likely diagnosis was an adverse effect/reaction to this product. Dog was admitted to run bloodwork and administer IV fluids and provide supportive care. He did well in hospital, was discharged that evening. On Sept 13, 2013, dog was much better and improving.