Health Canada
www.hc-sc.gc.ca
Common menu bar links
Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2012-1137
2. Registrant Information.
Registrant Reference Number: 1-26694312
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.
01-JUL-115. Location of incident.
Country: UNITED STATES
Prov / State: PENNSYLVANIA
6. Date incident was first observed.
13-JUN-11Product 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 5 Lbs 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).
Product was inappropriately applied to aged cats on June 11, 2011.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
unknown
4. Number of animals affected
1
5. Sex
Male
6. Age (provide a range if necessary )
12
7. Weight (provide a range if necessary )
Unknown
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
>24 hrs <=3 days / >24 h <=3 jours
11. List all symptoms
System
- Nervous and Muscular Systems
- Symptom - Seizure
- General
- Symptom - Death
12. How long did the symptoms last?
Persisted until death
13. Was medical treatment provided? Provide details in question 17.
Unknown
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
Cat developed symptoms on June 13, 2011 a few days after product was applied. Cat was taken to DVM.
To be determined by Registrant
18. Severity classification (if there is more than 1 possible classification
Death
19. Provide supplemental information here
Cat later died while at DVM on June 13th. Caller declined necropsy to determine cause of death. Label states to contact veterinarian before using product on aged cats.
Subform III: Domestic Animal Incident Report
1. Source of Report
Animal's Owner
2. Type of animal affected
Cat / Chat
3. Breed
unknown
4. Number of animals affected
1
5. Sex
Female
6. Age (provide a range if necessary )
15
7. Weight (provide a range if necessary )
Unknown
8. Route(s) of exposure
Skin
9. What was the length of exposure?
>1 wk <=1 mo / > 1 sem < = 1 mois
10. Time between exposure and onset of symptoms
>1 wk <=1 mo / > 1 sem < = 1 mois
11. List all symptoms
System
- 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 claims cat may have had a seizure on June 27, 2011 as they heard a kick against the bedroom door during the night.
To be determined by Registrant
18. Severity classification (if there is more than 1 possible classification
Death
19. Provide supplemental information here
Cat died on June 27, 2011. Cause of death is undetermined as caller refused necropsy. It is also clearly marked on label to consult veterinarian before using on aged (geriatric) cats.
Subform III: Domestic Animal Incident Report
1. Source of Report
Animal's Owner
2. Type of animal affected
Cat / Chat
3. Breed
unknown
4. Number of animals affected
1
5. Sex
Female
6. Age (provide a range if necessary )
12
7. Weight (provide a range if necessary )
Unknown
8. Route(s) of exposure
Skin
9. What was the length of exposure?
>1 wk <=1 mo / > 1 sem < = 1 mois
10. Time between exposure and onset of symptoms
>1 wk <=1 mo / > 1 sem < = 1 mois
11. List all symptoms
System
- Blood
- Symptom - Anemia
- General
- Symptom - Lethargy
- Nervous and Muscular Systems
- Symptom - Seizure
- Respiratory System
- Symptom - Respiratory distress
- General
- Symptom - Death
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?
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
Cat became symptomatic 19 days after product was applied on June 11, 2011. Cat was taken to DVM on June 30,2011 where cat was given fluids, abx (injection plus oral). When owner came home from work she gave the cat a dose of the oral abx after which the cat became very lethargic and limp.
To be determined by Registrant
18. Severity classification (if there is more than 1 possible classification
Death
19. Provide supplemental information here
Cat died on July 1st 2011 shortly after 12 am. Owner declined necropsy therefore unable to determine cause of death. Label clearly indicates not to use on aged cats without consulting a veterinarian.
