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Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2012-0015
2. Registrant Information.
Registrant Reference Number: 110134990
Registrant Name (Full Legal Name no abbreviations): Wellmark International
Address: 100 Stone Road West, Suite 111
City: Guelph
Prov / State: Ontario
Country: Canada
Postal Code: N1G5L3
3. Select the appropriate subform(s) for the incident.
Domestic Animal
4. Date registrant was first informed of the incident.
21-OCT-115. Location of incident.
Country: CANADA
Prov / State: ONTARIO
6. Date incident was first observed.
21-OCT-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. 21744 PMRA Submission No. EPA Registration No.
Product Name: Zodiac Flea and Tick Spray For Dogs and Cats
- Active Ingredient(s)
- (S)-METHOPRENE
- N-OCTYL BICYCLOHEPTENE DICARBOXIMIDE
- PIPERONYL BUTOXIDE
- PYRETHRINS
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).
On October 21, 2011 the owner sprayed 2 cats with the product to treat for fleas.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
Domestic Longhair
4. Number of animals affected
1
5. Sex
Female
6. Age (provide a range if necessary )
13.0
7. Weight (provide a range if necessary )
Unknown
8. Route(s) of exposure
Skin
9. What was the length of exposure?
Unknown / Inconnu
10. Time between exposure and onset of symptoms
>2 hrs <=8 hrs / > 2 h < = 8 h
11. List all symptoms
System
- Nervous and Muscular Systems
- Symptom - Recumbent
- Symptom - Muscle tremors
- Blood
- Symptom - Anemia
12. How long did the symptoms last?
Unknown / Inconnu
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?
4
Day(s) / Jour(s)
15. Outcome of the incident
Not recovered / Non 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
On October 21, 2011 the owner noticed the cat was symptomatic. The owner took the cat to the veterinarian and then called the Animal Product Safety Service (APSS) to obtain help. The APSS veterinarian stated that the product was unlikely to result in severe tremors, that central nervous system (CNS) depression could occur if this was an alcohol base, and that if ingested, mild gastrointestinal (GI) upset and/or a taste reaction could occur. The APSS assistant recommended that the owner have the veterinarian call for information and call back with questions.
To be determined by Registrant
18. Severity classification (if there is more than 1 possible classification
Major
19. Provide supplemental information here
The APSS veterinarian stated that the substance was considered to have a medium likelihood of causing the clinical situation. A short time after the owner called the APSS on October 21, 2011, the owner's regular veterinarian called the APSS to update the case. The regular veterinarian stated that the cat had a pre-existing flea condition that began on an unknown date and that at an unknown time that day the cat had developed tremors, but they had ended by the time the regular veterinarian called the APSS. The regular veterinarian stated that the cat was bathed and was given Methocarbamol, supportive care, fluid therapy, a chemistry profile, and a complete blood count (CBC). The regular veterinarian stated that the cat's temperature was recorded as 100.0 degrees Fahrenheit, which was within the normal range. The regular veterinarian stated that the cat's hematocrit value was recorded as 27.0 percent volume to volume (% v/v) and that the cat was anemic. The regular veterinarian said that the cat's serum glucose was normal. On October 26, 2011 an APSS assistant called the owner to update the case. The owner stated that the cat came home from the clinic on October 25, 2011, but had not yet fully recovered. The owner stated that on October 25, 2011 the cat no longer had a flea infestation or anemia, but was still mildly recumbent.
Subform 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
1
5. Sex
Male
6. Age (provide a range if necessary )
10.0
7. Weight (provide a range if necessary )
Unknown
8. Route(s) of exposure
Skin
9. What was the length of exposure?
Unknown / Inconnu
10. Time between exposure and onset of symptoms
>2 hrs <=8 hrs / > 2 h < = 8 h
11. List all symptoms
System
- General
- Symptom - Lethargy
- Gastrointestinal System
- Symptom - Drooling
12. How long did the symptoms last?
>8 hrs <=24 hrs / > 8 h < = 24 h
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?
17
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
On October 21, 2011 the owner noticed that the cat was symptomatic. The owner took the cat to the veterinarian and then called the Animal Product Safety Service (APSS) to obtain help. The APSS veterinarian stated that dermal irritation was possible and that topical pyrethrins could lead to paresthesia. The APSS assistant recommended that the owner have the veterinarian call for information and call back with questions.
To be determined by Registrant
18. Severity classification (if there is more than 1 possible classification
Moderate
19. Provide supplemental information here
A short time after the owner called the APSS on October 21, 2011, the owner's regular veterinarian called the APSS to update the case. The regular veterinarian stated that the cat was bathed and was being monitored at the veterinary facility. On October 26, 2011 an APSS assistant called the owner to update the case. The owner stated that the cat was released from the clinic on October 22, 2011 and had made a full recovery.
