Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2015-3922

2. Registrant Information.

Registrant Reference Number: 2015TH262

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

Address: 2920 Matheson Blvd

City: Mississauga

Prov / State: ON

Country: Canada

Postal Code: L9W 5R6

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

Domestic Animal

4. Date registrant was first informed of the incident.

05-AUG-15

5. Location of incident.

Country: UNITED STATES

Prov / State: UNKNOWN

6. Date incident was first observed.

02-JUL-13

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. 11556-155

Product Name: Seresto Collar - large dog

• Active Ingredient(s)
  • Flumethrin
  • IMIDACLOPRID
    • Guarantee/concentration 10 %

---

7. b) Type of formulation.

Other (specify)

Collar

Application Information

8. Product was applied?

Yes

9. Application Rate.

1

Other Units: collar

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).

Pet owner applied 1 seresto large dog collar on July 2 2013

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

Other

2. Type of animal affected

Dog / Chien

3. Breed

German Shepherd

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

5

7. Weight (provide a range if necessary )

120

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 hrs <=8 hrs / > 2 h < = 8 h

11. List all symptoms

System

• General
  • Symptom - Death

• Skin
  • Symptom - Other
  • Specify - dull hair coat
  • Symptom - Dry skin
  • Specify - dandruff

• General
  • Symptom - Lethargy

• Skin
  • Symptom - Hair loss
  • Specify - shedding

• General
  • Symptom - Hesitancy to move

• Gastrointestinal System
  • Symptom - Vomiting
  • Symptom - Loss of appetite

• Blood
  • Symptom - Other
  • Specify - hemoconcentration
  • Symptom - Leukocytosis
  • Symptom - Hyperglycemia

• Liver
  • Symptom - Elevated liver enzymes

• Blood
  • Symptom - Hypokalemia

• General
  • Symptom - Other
  • Specify - incrase abdominal detail on radiographs

• Cardiovascular System
  • Symptom - Other
  • Specify - cardiomegaly

• General
  • Symptom - Fever

• Cardiovascular System
  • Symptom - Arrhythmia
  • Specify - poor pulses

• Respiratory System
  • Symptom - Tachypnea

• General
  • Symptom - Pale mucous membrane colour

• Nervous and Muscular Systems
  • Symptom - Recumbent

• Gastrointestinal System
  • Symptom - Abdominal distension
  • Specify - distended abdomen

• Cardiovascular System
  • Symptom - Cardiac arrest

• Nervous and Muscular Systems
  • Symptom - Collapse

• Cardiovascular System
  • Symptom - Other
  • Specify - pericardial effusion

• General
  • Symptom - Cancer
  • Specify - right atrial hemangiosarcoma

12. How long did the symptoms last?

Persisted until death

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?

1

Day(s) / Jour(s)

15. Outcome of the incident

Died

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 02-Jul-2013, a 5 year old, 120 pound, spayed, female, German Shepherd Dog, in good condition with no known concomitant medical conditions, had 1 Seresto Large Dog (Flumethrin-Imidacloprid) collar placed around the neck by the owner.On 02-Jul-2013, approximately 2 hours post application the dog had a dull coat at the application site. On 09-Jul-2013, the dog the dullness had spread over the rest of the hair coat and the dog had dandruff. On 16-Jul-2013, the dog had shedding. The owner removed the collar. The dog continued to have clinical signs. On 22-Jul-2013, the owner placed the collar back on the dog. On approximately 31-Aug-2013, the dog became lethargic and did not want to walk (reluctant to move). On 08-Sep-2013, the dog began vomiting and would not eat. The owner took the dog to the veterinary clinic where they examined her and performed blood work that revealed hemoconcentration (abnormal test result), leukocytosis with granulocytosis (leukocytosis), an elevated blood urea nitrogen, elevated glucose (hyperglycemia), elevated alanine aminotransferase, and mild hypokalemia. The veterinarian also performed radiographs that showed decreased abdominal detail (abnormal radiograph finding) and cardiomegaly (cardiac enlargement). The patient was then taken to the emergencyveterinary clinic. The veterinarian examined the dog, noting a temperature of 104.2 (pyrexia), a heart rate of 180 (tachycardia), poor pulses (vascular disorder NOS), a respiratory rate of 48 (tachypnea), and pale pink mucous membranes. The dog was in lateral recumbency at that point, was minimally responsive, and had a distended abdomen. The veterinarian performed radiographs that showed an enlarged cardiac silhouette (cardiac enlargement) and a foreign body in the stomach (digestive tract stasis). The dog then collapsed and went into cardiac arrest. The veterinarian performed cardiopulmonary resuscitation, administered two doses of atropine sulfate, and two doses of epinephrine, but the dog died. After the cardiopulmonary resuscitation was performed, the veterinarian noted upon ultrasound that the dog had pericardial effusion, likely due to a right atrial hemangiosarcoma. No necropsy was performed

---

To be determined by Registrant

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

Death

19. Provide supplemental information here

N- Unlikely. Onset time of skin reactions consistent. However, generalized skin reactions are not anticipated with topical product administration. If any, skin reactions would be localized at the application site. Hair change at application site might be coincidental, since reaction is generalized. Other causes must be considered. Onset time of other signs is inconsistent. Reported systemic signs and fatal outcome are neither expected nor in line with pharmacotoxicological product profile and rather due to dogs underlying medical condition. No necropsy performed. However, reported symptoms, corresponding blood results, ultrasound and radiological findings lead to suspected diagnosis of an haemangiosarcoma. In the end, a product relation was deemed to be unlikely