Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2009-2915

2. Registrant Information.

Registrant Reference Number: 2009TH001

Registrant Name (Full Legal Name no abbreviations): Bayer Inc.

Address: 77 Belfied Road

City: Toronto

Prov / State: ON

Country: Canada

Postal Code: M9W 1G6

3. Select the appropriate subform(s) for the incident.

Domestic Animal

4. Date registrant was first informed of the incident.

10-MAR-09

5. Location of incident.

Country: CANADA

Prov / State: BRITISH COLUMBIA

6. Date incident was first observed.

25-AUG-05

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.

Product Name: advantage

• Active Ingredient(s)
  • IMIDACLOPRID

---

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).

Owner reports having applied advantage, no note was made of source or size of advantage used. The animals record does note that the owner applied it topically between the shoulder blades.

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

Medical Professional

2. Type of animal affected

Cat / Chat

3. Breed

Domestic Short Hair

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

0.75

7. Weight (provide a range if necessary )

4.95

kg

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

Unknown / Inconnu

11. List all symptoms

System

• Skin
  • Symptom - Inflammation of the skin
  • Specify - pyoderma

12. How long did the symptoms last?

>3 days <=1 wk / >3 jours <=1 sem

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

Recvrd resid.effects/Rétabli séquelles

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 presented to clinic Aug 25 2005 after the owner applied advantage. There is no comment on where the advantage was purchased, dose etc. The cat had a pyoderma between the shoulder blades. Pyoderma was treated with baytril and a program 40 injection. Aug 31 2005 the medication was switched to a liquid antibiotic (clavamox) and revolution was applied. Sofi was noted as recovering well.

---

To be determined by Registrant

18. Severity classification (if there is more than 1 possible classification

Moderate

19. Provide supplemental information here

Similar lesions to the initial incident reoccurred. Cat presented to clinic Aug 25 2005 after the owner applied advantage. There is no comment on where the advantage was purchased, dose etc. The cat had a pyoderma between the shoulder blades. Pyoderma was treated with baytril and a program 40 injection. Aug 31 2005 the medication was switched to a liquid antibiotic (clavamox) and revolution was applied. Sofi was noted as recovering well. Dec 9 2007 the cat presented for a bald spot between the shoulder blades, the area was not pruritic, surolan was prescribed for topical use. Jan 20 2009 the cat presented for a lacerated ear and focal alopecia (3 mm spot) on the right face and left hock, On examination with a woods lamp, no flourescence was noted. No pruritis. Dr elected not to treat. Vaccines were given. Feb 19 2009 the cat presented with alopecia, scabbing, inflammation and redness on the caudal neck area. A biopsy was performed. A U/A revealed a concurrent UTI. Biopsy site healed well. Test results : FeLV // FIV negative, potassium 3.8 (N 3.9 - 5.3 mmol/L), albumin 39 (N 23- 33 g/L), mean corp HGB 17.8 (N 13.5 - 17.3 pg), lymphocytes 1.495 (N 1.770 - 6.560 x 10e9/L) Urinalysis by cystocentesis dg 1.058, protein 1+, rbc 1-3, wbc 3-6, urine culture enterococcus greater than 10*5 cfu/ml, Histology - "The skin exhibits significant ulceration with superficial neutrophilic infiltration. Given the location on the dorsal thorax, the possibility of feline idiopathic ulcerative dermatitis (FIUD) should be considered. The cause of this condition is unknown. The lesion presents as an area of of ulceration that may continue to become larger generally over the dorsal neck or thorax area. There is some thought that it may be associated with a hypersensitivity or possibly be secondary to an injection reaction. Response to treatment is variable."