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Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2016-1028
2. Registrant Information.
Registrant Reference Number: 2014-CA-00453
Registrant Name (Full Legal Name no abbreviations): Virbac Animal Health
Address: 3200 Meacham Blvd.
City: Fort Worth
Prov / State: TX
Country: United States
Postal Code: 76137
3. Select the appropriate subform(s) for the incident.
Domestic Animal
4. Date registrant was first informed of the incident.
05-NOV-145. Location of incident.
Country: CANADA
Prov / State: ONTARIO
6. Date incident was first observed.
Unknown
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. 2382-54
Product Name: Otomite Plus Canada
- Active Ingredient(s)
- N-OCTYL BICYCLOHEPTENE DICARBOXIMIDE
- PIPERONYL BUTOXIDE
- PYRETHRINS
7. b) Type of formulation.
Application Information
8. Product was applied?
Yes
9. Application Rate.
2.15Units: %
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).
PYRETHRINS 0.15%, PIPERONYL BUTOXIDE 1.50 %, N-OCTYL BICYCLOHEPTENE DICARBOXIMIDE 0.50%. On 11/05/2014, sponsor was contacted to report an apparent efficacy failure of OTOMITE PLUS (0.15% pyrethrins/1.50% piperonyl butoxide/0.50% n-Octyl bicycloheptene dicarboximide) Ear Miticide. According to a technician at Algonquin Animal Hospital, three cats were diagnosed with moderate to severe ear mite infestations on an unspecified date. The cats ears were cleaned and OTOMITE PLUS was dispensed to be applied once every three days for nine days. Dosage course was repeated.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
Medical Professional
2. Type of animal affected
Cat / Chat
3. Breed
Unknown
4. Number of animals affected
3
5. Sex
Unknown
6. Age (provide a range if necessary )
Unknown
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
>2 hrs <=8 hrs / > 2 h < = 8 h
11. List all symptoms
System
- General
- Symptom - Parasitism
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?
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
On 11/05/2014, sponsor was contacted to report an apparent efficacy failure of OTOMITE PLUS (0.15% pyrethrins/1.50% piperonyl butoxide/0.50% n-Octyl bicycloheptene dicarboximide) Ear Miticide. According to a technician at (name) Animal Hospital, three cats were diagnosed with moderate to severe ear mite infestations on an unspecified date. The cats ears were cleaned and OTOMITE PLUS was dispensed to be applied once every three days for nine days. At a recheck examination on an unspecified date, live ear mites were observed. The animal owner was instructed to repeat the dosage course of OTOMITE PLUS. Only two cats were brought to the clinic for a second recheck examination and ear mites were persisting. The two cats were treated with Advantage and the ear mites resolved. The outcome of the third cat was not provided. No further information is expected.
To be determined by Registrant
18. Severity classification (if there is more than 1 possible classification
Moderate
