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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2013-6626

2. Registrant Information.

Registrant Reference Number: 5080061

Registrant Name (Full Legal Name no abbreviations): Sure-Gro Inc.

Address: 150 Savannah Oaks Dr.

City: Brantford

Prov / State: Ontario

Country: Canada

Postal Code: N3V 1E7

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

Human

4. Date registrant was first informed of the incident.

22-MAY-13

5. Location of incident.

Country: CANADA

Prov / State: ONTARIO

6. Date incident was first observed.

24-APR-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. 27492      PMRA Submission No.       EPA Registration No.

Product Name: Wilson Riddex Bloks Rat and Mouse Bait

  • Active Ingredient(s)
    • DIPHACINONE (PRESENT IN FREE FORM OR AS SODIUM SALT)

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: Res. - In Home / Rés. - à l'int. maison

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?

Unknown

Subform II: Human Incident Report (A separate form for each person affected)

1. Source of Report.

Other

2. Demographic information of data subject

Sex: Female

Age: >19 <=64 yrs / >19 <=64 ans

3. List all symptoms, using the selections below.

System

  • Respiratory System
    • Symptom - Shortness of breath
    • Symptom - Coughing

4. How long did the symptoms last?

Unknown / Inconnu

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

Unknown

6. a) Was the person hospitalized?

Unknown

6. b) For how long?

7. Exposure scenario

Non-occupational

8. How did exposure occur? (Select all that apply)

Contact with treated area

What was the activity? rodenticide applied in the attic of the house

9. If the exposure occured during application or re-entry, what protective clothing was worn? (select all that apply)

None

10. Route(s) of exposure.

Respiratory

11. What was the length of exposure?

>1 mo <= 6 mos / > 1 mois < = 6 mois

12. Time between exposure and onset of symptoms.

>1 mo <=2 mos / > 1 mois < = 2 mois

13. Provide any additional details about the incident (eg. description of the frequency and severity of the symptoms, type of medical treatment, results from medical tests, outcome of the incident, amount of pesticide exposed to, etc.)

S. Caller stated she put down \fs23 Wilson\ ae Riddex\ ae Bloks Rat Mouse Bait 4 months ago in the attic and her and her family have been have mild respitory distress ever since. caller is pregnant, transferred to SPI The family is in good health with no meds or allergies O. shortness of breath, Coughing up phelm A. Acute, adult/pediatric, inhaltion, R. Transferred to SPI Patient #1 Therapies: Unknown if therapy provided Patient #2 Therapies: Unknown if therapy provided Patient #3 Therapies: Unknown if therapy provided S: Spoke with caller no ingestion. She had them placed in the attic and is concerned that rat's may not have finished them. Their symptoms started shortly after placing them in the attic a couple months ago. She has already been to PCP regarding the sx. O: Shortness of breath, coughing up phlegm A: Chronic adult possible inhalation of Wilson Riddex Bloks Rat and Mouse Bait, sx unlikely related R: Would not expect sx from inhalation of product. Sx come from repeated ingestions or large acute ingestions. Sx include bruising and bleeding. Would not expect respiratory sx from ingestion of product. If sx persistent would recommend seeking medical attention CB with further quesitons/concerns cc/ap

To be determined by Registrant

14. Severity classification.

Minor

15. Provide supplemental information here.

The information contained in this report is based on self-reported statements provided to the registrant during telephone Interview(s). These self-reported descriptions of an incident have not been independently verified to be factually correct or complete descriptions of the incident. For that reason, information contained in this report does not and can not form the basis for a determination of whether the reported clinical effects are causally related to exposure to the product identified.

Subform II: Human Incident Report (A separate form for each person affected)

1. Source of Report.

Other

2. Demographic information of data subject

Sex: Male

Age: >19 <=64 yrs / >19 <=64 ans

3. List all symptoms, using the selections below.

System

  • Respiratory System
    • Symptom - Shortness of breath
    • Symptom - Coughing

4. How long did the symptoms last?

Unknown / Inconnu

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

Unknown

6. a) Was the person hospitalized?

Unknown

6. b) For how long?

7. Exposure scenario

Non-occupational

8. How did exposure occur? (Select all that apply)

Contact with treated area

What was the activity? Rodenticide applied in the attic

9. If the exposure occured during application or re-entry, what protective clothing was worn? (select all that apply)

None

10. Route(s) of exposure.

Respiratory

11. What was the length of exposure?

>1 mo <= 6 mos / > 1 mois < = 6 mois

12. Time between exposure and onset of symptoms.

>1 mo <=2 mos / > 1 mois < = 2 mois

13. Provide any additional details about the incident (eg. description of the frequency and severity of the symptoms, type of medical treatment, results from medical tests, outcome of the incident, amount of pesticide exposed to, etc.)

S. Caller stated she put down \fs23 Wilson\ae Riddex\ae Bloks Rat Mouse Bait 4 months ago in the attic and her and her family have been have mild respitory distress ever since. caller is pregnant, transferred to SPI The family is in good health with no meds or allergies O. shortness of breath, Coughing up phelm A. Acute, adult/pediatric, inhaltion, R. Transferred to SPI Patient #1 Therapies: Unknown if therapy provided Patient #2 Therapies: Unknown if therapy provided Patient #3 Therapies: Unknown if therapy provided S: Spoke with caller no ingestion. She had them placed in the attic and is concerned that rat's may not have finished them. Their symptoms started shortly after placing them in the attic a couple months ago. She has already been to PCP regarding the sx. O: Shortness of breath, coughing up phlegm A: Chronic adult possible inhalation of Wilson Riddex Bloks Rat and Mouse Bait, sx unlikely related R: Would not expect sx from inhalation of product. Sx come from repeated ingestions or large acute ingestions. Sx include bruising and bleeding. Would not expect respiratory sx from ingestion of product. If sx persistent would recommend seeking medical attention CB with further quesitons/concerns cc/ap

To be determined by Registrant

14. Severity classification.

Minor

15. Provide supplemental information here.

The information contained in this report is based on self-reported statements provided to the registrant during telephone Interview(s). These self-reported descriptions of an incident have not been independently verified to be factually correct or complete descriptions of the incident. For that reason, information contained in this report does not and can not form the basis for a determination of whether the reported clinical effects are causally related to exposure to the product identified.

Subform II: Human Incident Report (A separate form for each person affected)

1. Source of Report.

Other

2. Demographic information of data subject

Sex: Male

Age: <=1 yr / < = 1 an

3. List all symptoms, using the selections below.

System

  • Respiratory System
    • Symptom - Coughing
    • Symptom - Shortness of breath

4. How long did the symptoms last?

Unknown / Inconnu

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

Unknown

6. a) Was the person hospitalized?

Unknown

6. b) For how long?

7. Exposure scenario

Non-occupational

8. How did exposure occur? (Select all that apply)

Contact with treated area

What was the activity? Roddenticide applied in the attic

9. If the exposure occured during application or re-entry, what protective clothing was worn? (select all that apply)

None

10. Route(s) of exposure.

Respiratory

11. What was the length of exposure?

>1 mo <= 6 mos / > 1 mois < = 6 mois

12. Time between exposure and onset of symptoms.

>1 mo <=2 mos / > 1 mois < = 2 mois

13. Provide any additional details about the incident (eg. description of the frequency and severity of the symptoms, type of medical treatment, results from medical tests, outcome of the incident, amount of pesticide exposed to, etc.)

S. Caller stated she put down \fs23 Wilson\ae Riddex\ae Bloks Rat Mouse Bait 4 months ago in the attic and her and her family have been have mild respitory distress ever since. caller is pregnant, transferred to SPI The family is in good health with no meds or allergies O. shortness of breath, Coughing up phelm A. Acute, adult/pediatric, inhaltion, R. Transferred to SPI Patient #1 Therapies: Unknown if therapy provided Patient #2 Therapies: Unknown if therapy provided Patient #3 Therapies: Unknown if therapy provided S: Spoke with caller no ingestion. She had them placed in the attic and is concerned that rat's may not have finished them. Their symptoms started shortly after placing them in the attic a couple months ago. She has already been to PCP regarding the sx. O: Shortness of breath, coughing up phlegm A: Chronic adult possible inhalation of Wilson Riddex Bloks Rat and Mouse Bait, sx unlikely related R: Would not expect sx from inhalation of product. Sx come from repeated ingestions or large acute ingestions. Sx include bruising and bleeding. Would not expect respiratory sx from ingestion of product. If sx persistent would recommend seeking medical attention CB with further quesitons/concerns cc/ap

To be determined by Registrant

14. Severity classification.

Minor

15. Provide supplemental information here.

The information contained in this report is based on self-reported statements provided to the registrant during telephone Interview(s). These self-reported descriptions of an incident have not been independently verified to be factually correct or complete descriptions of the incident. For that reason, information contained in this report does not and can not form the basis for a determination of whether the reported clinical effects are causally related to exposure to the product identified.