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Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2013-1034
2. Registrant Information.
Registrant Reference Number: 1-30008732
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.
04-MAY-125. Location of incident.
Country: UNITED STATES
Prov / State: OKLAHOMA
6. Date incident was first observed.
01-MAY-12Product 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 Ultra Guard Plus Drops for Cats 5lbs and Over
- Active Ingredient(s)
- (S)-METHOPRENE
- Guarantee/concentration 3.6 %
- ETOFENPROX
- Guarantee/concentration 40 %
- (S)-METHOPRENE
7. b) Type of formulation.
Liquid
Application Information
8. Product was applied?
Yes
9. Application Rate.
1.8Units: 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).
Caller applied product to cats on April 30, 2012.To be determined by Registrant
12. In your opinion, was the product used according to the label instructions?
YesSubform III: Domestic Animal Incident Report
1. Source of Report
Animal's Owner
2. Type of animal affected
Cat / Chat
3. Breed
Domestic Shorthair
4. Number of animals affected
6
5. Sex
Unknown
6. Age (provide a range if necessary )
0.25
7. Weight (provide a range if necessary )
5
lbs
8. Route(s) of exposure
Skin
9. What was the length of exposure?
>24 hrs <=3 days / >24 h <=3 jours
10. Time between exposure and onset of symptoms
>8 hrs <=24 hrs / > 8 h < = 24 h
11. List all symptoms
System
- Gastrointestinal System
- Symptom - Anorexia
- Nervous and Muscular Systems
- Symptom - Muscle weakness
- General
- Symptom - Death
12. How long did the symptoms last?
Persisted until death
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
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
Caller applied product to kittens on April 30, 2012. The next day they became symptomatic. Caller said she bathed cats with dish soap but symptoms continued. She said she did not take them to the DVM because she could not afford to. She used the product on some of her adult cats and they are not having any problems.
To be determined by Registrant
18. Severity classification (if there is more than 1 possible classification
Death
19. Provide supplemental information here
Necropsy was offered to determine true cause of death. These symptoms are not expected from normal use of product.
Subform III: Domestic Animal Incident Report
1. Source of Report
Animal's Owner
2. Type of animal affected
Cat / Chat
3. Breed
Cat Domestic Shorthair
4. Number of animals affected
1
5. Sex
Male
6. Age (provide a range if necessary )
1
7. Weight (provide a range if necessary )
8
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
>8 hrs <=24 hrs / > 8 h < = 24 h
11. List all symptoms
System
- Gastrointestinal System
- Symptom - Anorexia
- Nervous and Muscular Systems
- Symptom - Muscle weakness
- General
- Symptom - Death
12. How long did the symptoms last?
Persisted until death
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
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
Caller applied product to cat on April 30, 2012. The next day cat became symptomatic. Caller said she bathed cat with dish soap but symptoms continued. She said she did not take cat to the DVM because she could not afford to. She used the product on some of her adult cats and they are not having any problems.
To be determined by Registrant
18. Severity classification (if there is more than 1 possible classification
Death
19. Provide supplemental information here
Necropsy was offered to determine true cause of death. These symptoms are not expected from normal use of product.
Subform III: Domestic Animal Incident Report
1. Source of Report
Animal's Owner
2. Type of animal affected
Cat / Chat
3. Breed
Domestic Short Hair
4. Number of animals affected
2
5. Sex
Unknown
6. Age (provide a range if necessary )
0.33
7. Weight (provide a range if necessary )
Unknown
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
>8 hrs <=24 hrs / > 8 h < = 24 h
11. List all symptoms
System
- Gastrointestinal System
- Symptom - Anorexia
- Nervous and Muscular Systems
- Symptom - Muscle weakness
- Respiratory System
- Symptom - Other
- Specify - hardly breathing
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
Unknown/Inconnu
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
Caller applied product to kittens on April 30, 2012. The next day kittens became symptomatic. Caller said she bathed kittens with dish soap but symptoms continued. She said she did not take the kittens to the DVM because she could not afford to. She used the product on some of her adult cats and they are not having any problems.
To be determined by Registrant
18. Severity classification (if there is more than 1 possible classification
Major
19. Provide supplemental information here
Suggestion was made to caller to take these kittens to be seen by her DVM. Symptoms experienced by kittens are not expected from normal use of the product.
