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Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2016-0043
2. Registrant Information.
Registrant Reference Number: 150120453
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.
01-SEP-155. Location of incident.
Country: CANADA
Prov / State: ONTARIO
6. Date incident was first observed.
01-JUN-15Product 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. 28743 PMRA Submission No. EPA Registration No.
Product Name: Zodiac Spot On II Flea Control For Cats And Kittens
- Active Ingredient(s)
- (S)-METHOPRENE
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 June 1, 2015 the owner applied the full vial of the product onto the 2 cats. The following month, the owner began inappropriately applying 1/2 of the tube of the product onto the 2 cats every 2 weeks, with the last application on August 31, 2015.To be determined by Registrant
12. In your opinion, was the product used according to the label instructions?
No
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 )
3.0
7. Weight (provide a range if necessary )
15.0
lbs
8. Route(s) of exposure
Skin
Oral
9. What was the length of exposure?
Unknown / Inconnu
10. Time between exposure and onset of symptoms
<=30 min / <=30 min
11. List all symptoms
System
- Gastrointestinal System
- Symptom - Drooling
12. How long did the symptoms last?
Unknown / Inconnu
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
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
On June 1, 2015 the cat developed hypersalivation. On September 1, 2015 the owner contacted the Animal Product Safety Service (APSS), to report to the company that the volume of the product is too much for cats. The APSS veterinarian stated we very commonly see taste reactions to newly applied spot on products that are licked because of the bitter taste of the active ingredients or of the carriers. The APSS veterinarian also stated by using it off label and applying half of the product every 2 weeks, owner found that the taste reactions no longer occurred; however, the efficacy would likely be decreased. The APSS veterinarian further stated s-methoprene is an insect growth regulator (IGR). The APSS veterinarian stated if ingested there could be hypersalivation and nausea. The APSS veterinarian recommended taking the cat to the veterinarian (to discuss an appropriate flea treatment alternative with smaller application volume) and flea treatment (from the veterinarian, also treat the home environment).
To be determined by Registrant
18. Severity classification (if there is more than 1 possible classification
Minor
19. Provide supplemental information here
The APSS veterinarian stated that the substance was considered to have a low likelihood of causing the clinical situation. A follow up was not performed, because additional information was not expected. Therefore, the outcome of this case is unknown. Signs expected to be mild and self-limiting. Off label 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 Shorthair
4. Number of animals affected
1
5. Sex
Female
6. Age (provide a range if necessary )
Unknown
7. Weight (provide a range if necessary )
Unknown
8. Route(s) of exposure
Skin
Oral
9. What was the length of exposure?
Unknown / Inconnu
10. Time between exposure and onset of symptoms
<=30 min / <=30 min
11. List all symptoms
System
- Gastrointestinal System
- Symptom - Drooling
12. How long did the symptoms last?
Unknown / Inconnu
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
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
On June 1, 2015 the cat developed hypersalivation. On September 1, 2015 the owner contacted the Animal Product Safety Service (APSS), to report to the company that the volume of the product is too much for cats. The APSS veterinarian stated we very commonly see taste reactions to newly applied spot on products that are licked because of the bitter taste of the active ingredients or of the carriers. The APSS veterinarian also stated by using it off label and applying half of the product every 2 weeks, owner found that the taste reactions no longer occurred; however, the efficacy would likely be decreased. The APSS veterinarian further stated s-methoprene is an insect growth regulator (IGR) and primary concerns from topical administration are for mild dermal irritation and redness, usually from the carriers. The APSS veterinarian finally stated if ingested there could be hypersalivation and nausea. The APSS veterinarian recommended taking the cat to the veterinarian (to discuss an appropriate flea treatment alternative with smaller application volume) and flea treatment (from the veterinarian, also treat the home environment).
To be determined by Registrant
18. Severity classification (if there is more than 1 possible classification
Minor
19. Provide supplemental information here
The APSS veterinarian stated that the substance was considered to have a low likelihood of causing the clinical situation. A follow up was not performed, because additional information was not expected. Therefore, the outcome of this case is unknown.
