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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2016-1213

2. Registrant Information.

Registrant Reference Number: ProPharma case: 1-42958678

Registrant Name (Full Legal Name no abbreviations): HACCO, Inc.

Address: 110 Hopkins Drive

City: Randolph

Prov / State: Wisconsin

Country: USA

Postal Code: 53956

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

Domestic Animal

4. Date registrant was first informed of the incident.

16-JAN-16

5. Location of incident.

Country: UNITED STATES

Prov / State: TEXAS

6. Date incident was first observed.

16-JAN-16

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. 61282-12

Product Name: Ramik Bars All Weather Rat/Mouse Killer

  • Active Ingredient(s)
    • DIPHACINONE (PRESENT IN FREE FORM OR AS SODIUM SALT)
      • Guarantee/concentration .005 %

7. b) Type of formulation.

Bait

Application Information

8. Product was applied?

Unknown

9. Application Rate.

10. Site pesticide was applied to (select all that apply).

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 III: Domestic Animal Incident Report

1. Source of Report

Animal's Owner

2. Type of animal affected

Dog / Chien

3. Breed

Great Dane

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

1

7. Weight (provide a range if necessary )

65

lbs

8. Route(s) of exposure

Oral

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

Unknown / Inconnu

11. List all symptoms

System

  • General
    • Symptom - Death
  • Nervous and Muscular Systems
    • Symptom - Disorientation
    • Symptom - Other
    • Specify - running into things
  • General
    • Symptom - Other
    • Specify - blood came from mouth prior to death

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?

Accidental ingestion/Ingestion accident.

17. Provide any additional details about the incident

(eg. description of the frequency and severity of the symptoms

1-42958678 - The reporter, a pet owner, indicated his dog may have been exposed to a rodenticide containing the active ingredient diphacinone. The reporter did not witness the exposure but stated that he was concerned that his dog ingested two of the bars about 2 hours prior to his initial call. The reporter was advised to seek medical attention where his dog could be treated with the antidote, vitamin K1. On follow-up call, two days later, the reporter indicated that he did not bring his dog to the veterinarian because he could not find one that was open. He indicated that the dog died at home one day after he had initially called. Prior to death the dog was disorientated and running into things and just before the dog died there was some blood coming out of his mouth. No additional information is available.


To be determined by Registrant

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

Death

19. Provide supplemental information here