Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2007-6980
2. Registrant Information.
Registrant Reference Number: CA2007-00222
Registrant Name (Full Legal Name no abbreviations): SCHERING-PLOUGH ANIMAL HEALTH
Address: 3535 TRANS-CANADA
City: POINTE-CLAIRE
Prov / State: QUEBEC
Country: CANADA
Postal Code: H9R-1B4
3. Select the appropriate subform(s) for the incident.
Domestic Animal
4. Date registrant was first informed of the incident.
14-JUN-07
5. Location of incident.
Country: CANADA
Prov / State: MANITOBA
6. Date incident was first observed.
30-MAY-07
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. 22968
PMRA Submission No.
EPA Registration No.
Product Name: Defend Exspot
7. b) Type of formulation.
Application Information
8. Product was applied?
Yes
9. Application Rate.
4
Units: 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).
To be determined by Registrant
12. In your opinion, was the product used according to the label instructions?
Yes
Subform III: Domestic Animal Incident Report
1. Source of Report
Medical Professional
2. Type of animal affected
Dog / Chien
3. Breed
Labrador Retriever
4. Number of animals affected
1
5. Sex
Male
6. Age (provide a range if necessary )
3
7. Weight (provide a range if necessary )
81.4
lbs
8. Route(s) of exposure
Skin
9. What was the length of exposure?
>1 mo <= 6 mos / > 1 mois < = 6 mois
10. Time between exposure and onset of symptoms
>2 mos <=6 mos / > 2 mois < = 6 mois
11. List all symptoms
System
- Skin
- Symptom - Irritated skin
- Symptom -
- Specify - Staph Folliculitis in large area
12. How long did the symptoms last?
>1 mo and <= 2mos / >1 mois et < = 2mois
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
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
Adverse Event Dog was treated with Defend at end of April and again on or about 18 May 2007. On 30 May, presented at clinic with skin irritation on upper chest. Large area of Staph folliculitis. Shaved, bathed and treated with antibiotics. On 07 June, had spread to areas on back. Baytril was prescribed. 13 June, chest area improving, but neck/back areas not. Continue with Baytril and given oral Prednisone. Attending vet considers this to be a secondary infection with primary reaction to Defend. Case to be followed. FOLLOW-UP 17 July 07: SPAH vet talked with attending vet on 09 July. The dog had shown great improvement and was considered recovered. Vet was to contact owner to check, and call SPAH vet if dog's skin condition not completely healed. No further contact to date. Recovered. Case closed.
To be determined by Registrant
18. Severity classification (if there is more than 1 possible classification
Moderate
19. Provide supplemental information here