Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2013-4395
2. Registrant Information.
Registrant Reference Number: Hartz 1-32682514
Registrant Name (Full Legal Name no abbreviations): WELLMARK INTERNATIONAL
Address: 100 STONE ROAD WEST, SUITE 111
City: GUELPH
Prov / State: ON
Country: CANADA
Postal Code: N1G 5L3
3. Select the appropriate subform(s) for the incident.
Domestic Animal
4. Date registrant was first informed of the incident.
07-FEB-13
5. Location of incident.
Country: UNITED STATES
Prov / State: MISSISSIPPI
6. Date incident was first observed.
06-FEB-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.
PMRA Submission No.
EPA Registration No. 2724-504-2596
Product Name: Hartz UltraGuard Pro Flea and Tick Drops for Cats 5lbs and over
- Active Ingredient(s)
- (S)-METHOPRENE
- Guarantee/concentration 3.6 %
- ETOFENPROX
- Guarantee/concentration 40 %
7. b) Type of formulation.
Liquid
Application Information
8. Product was applied?
Yes
9. Application Rate.
1.8
Units: mL
10. Site pesticide was applied to (select all that apply).
Site: Res. - In Home / Rés. - à l'int. maison
11. Provide any additional information regarding application (how it was applied, amount applied, the size of the area treated etc).
Product was applied to geriatric cat. Unknown if caller consulted with veterinarian prior to treating elderly cat.
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
Cat / Chat
3. Breed
mixed breed, domestic short hair
4. Number of animals affected
1
5. Sex
Male
6. Age (provide a range if necessary )
12
7. Weight (provide a range if necessary )
12
lbs
8. Route(s) of exposure
Skin
9. What was the length of exposure?
>8 hrs <= 24 hrs / >8 h <= 24 h
10. Time between exposure and onset of symptoms
>2 hrs <=8 hrs / > 2 h < = 8 h
11. List all symptoms
System
- Gastrointestinal System
- Symptom - Rectal hemorrhage
- Symptom - Vomiting
12. How long did the symptoms last?
Persisted until death
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
Died
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
2/6/13 caller applied product at 8:30 am caller retuned home 1:00 pm cat was symptomatic. Pet was taken to Vet where it was stabilized, no description of medical care or diagnostics. Pet returned home, died later that evening.
To be determined by Registrant
18. Severity classification (if there is more than 1 possible classification
Death
19. Provide supplemental information here
Label directions not followed. Symptoms were inconsistent with tox profile with active ingredient. Unknown if veterinarian was consulted prior to treatment. Staff veterinarian determined doubtfully related to product use.