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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2009-0637

2. Registrant Information.

Registrant Reference Number: 388956

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

Address: Suite 100, 3131 114 Avenue SE

City: Calgary

Prov / State: AB

Country: Canada

Postal Code: T2Z 3X2

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

Domestic Animal

4. Date registrant was first informed of the incident.

08-OCT-08

5. Location of incident.

Country: UNITED STATES

Prov / State: NORTH CAROLINA

6. Date incident was first observed.

04-OCT-08

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: Admire (non-specific)

  • Active Ingredient(s)
    • IMIDACLOPRID
      • Unknown

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).

Please refer to field 13 on Subform II or field 17 of subform III for a detailed description regarding application.

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

Dog / Chien

3. Breed

Black and Tan Coonhound

4. Number of animals affected

1

5. Sex

Unknown

6. Age (provide a range if necessary )

0.25

7. Weight (provide a range if necessary )

7

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

<=15 min / <=15 min

10. Time between exposure and onset of symptoms

>24 hrs <=3 days / >24 h <=3 jours

11. List all symptoms

System

  • Respiratory System
    • Symptom - Coughing
    • Symptom - Pneumonia
    • Specify - Pneumonia

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

10/8/2008 Caller is a veterinarian treating dogs that had product misapplied to them by the owner for flea control 2 to 3 days prior to the onset of symptoms. Caller does not know the concentration or amount of product that was applied to the dogs. All he was told is that it was Admire insecticide. Yesterday the first dog presented to caller with a rattling cough. Caller diagnosed the dog with pneumonia and prescribed antibiotics. The owner reported to the caller that a second dog at home was sluggish. Caller advised observing the second dog and to bring the dog in for an evaluation if symptoms persist. The second dog died during the night. Today the owner brought in a third dog that was also acting sluggish. Caller found the third dog to be hypothermic and moderately ataxic. Caller is treating the third dog supportively and has placed the dog on antibiotics in case of an undetectable pneumonia. 11/5/2008 Attempted callback for follow up. The facility is closed, unable to leave a message. 11/11/2008 Callback to original caller for follow up. The clinic sent the third dog home with antibiotics. The clinic has not heard from the owners since leaving the clinic.


To be determined by Registrant

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

Moderate

19. Provide supplemental information here

Subform III: Domestic Animal Incident Report

1. Source of Report

Medical Professional

2. Type of animal affected

Dog / Chien

3. Breed

Black and Tan Coonhound

4. Number of animals affected

1

5. Sex

Unknown

6. Age (provide a range if necessary )

0.25

7. Weight (provide a range if necessary )

7

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

<=15 min / <=15 min

10. Time between exposure and onset of symptoms

>24 hrs <=3 days / >24 h <=3 jours

11. List all symptoms

System

  • General
    • Symptom - Death
    • Symptom - Lethargy

12. How long did the symptoms last?

Persisted until death

13. Was medical treatment provided? Provide details in question 17.

No

14. a) Was the animal hospitalized?

No

14. b) How long was the animal hospitalized?

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

10/8/2008 Caller is a veterinarian treating dogs that had product applied to them by the owner for flea control 2 to 3 days prior to the onset of symptoms. Caller does not know the concentration or amount of product that was applied to the dogs. All he was told is that it was Admire insecticide. Yesterday the first dog presented to caller with a rattling cough. Caller diagnosed the dog with pneumonia and prescribed antibiotics. The owner reported to the caller that a second dog at home was sluggish. Caller advised observing the second dog and to bring the dog in for an evaluation if symptoms persist. The second dog died during the night. Today the owner brought in a third dog that was also acting sluggish. Caller found the third dog to be hypothermic and moderately ataxic. Caller is treating the third dog supportively and has placed the dog on antibiotics in case of an undetectable pneumonia. 11/5/2008 Attempted callback for follow up. The facility is closed, unable to leave a message. 11/11/2008 Callback to original caller for follow up. The clinic sent the third dog home with antibiotics. The clinic has not heard from the owners since leaving the clinic.


To be determined by Registrant

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

Death

19. Provide supplemental information here

Subform III: Domestic Animal Incident Report

1. Source of Report

Medical Professional

2. Type of animal affected

Dog / Chien

3. Breed

Black and Tan Coonhound

4. Number of animals affected

1

5. Sex

Unknown

6. Age (provide a range if necessary )

0.25

7. Weight (provide a range if necessary )

7

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

<=15 min / <=15 min

10. Time between exposure and onset of symptoms

>24 hrs <=3 days / >24 h <=3 jours

11. List all symptoms

System

  • General
    • Symptom - Hypothermia
    • Symptom - Lethargy
  • Nervous and Muscular Systems
    • Symptom - Ataxia

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?

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

10/8/2008 Caller is a veterinarian treating dogs that had product applied to them by the owner for flea control 2 to 3 days prior to the onset of symptoms. Caller does not know the concentration or amount of product that was applied to the dogs. All he was told is that it was Admire insecticide. Yesterday the first dog presented to caller with a rattling cough. Caller diagnosed the dog with pneumonia and prescribed antibiotics. The owner reported to the caller that a second dog at home was sluggish. Caller advised observing the second dog and to bring the dog in for an evaluation if symptoms persist. The second dog died during the night. Today the owner brought in a third dog that was also acting sluggish. Caller found the third dog to be hypothermic and moderately ataxic. Caller is treating the third dog supportively and has placed the dog on antibiotics in case of an undetectable pneumonia. 11/5/2008 Attempted callback for follow up. The facility is closed, unable to leave a message. 11/11/2008 Callback to original caller for follow up. The clinic sent the third dog home with antibiotics. The clinic has not heard from the owners since leaving the clinic.


To be determined by Registrant

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

Moderate

19. Provide supplemental information here