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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2019-3121

2. Registrant Information.

Registrant Reference Number: USA-BAYERBAH-2019-US0021389 (Report 562738)

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

Address: 2920 matheson BLVD

City: Mississaugua

Prov / State: ON

Country: Canada

Postal Code: L4W 5R6

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

Domestic Animal

4. Date registrant was first informed of the incident.

10-MAY-19

5. Location of incident.

Country: UNITED STATES

Prov / State: SOUTH DAKOTA

6. Date incident was first observed.

10-MAY-19

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. 11556-148

Product Name: Corathon

  • Active Ingredient(s)
    • COUMAPHOS
      • Guarantee/concentration 15 %
    • DIAZINON
      • Guarantee/concentration 35 %

7. b) Type of formulation.

Other (specify)

Ear tag

Application Information

8. Product was applied?

Yes

9. Application Rate.

1

Other Units: 1 Ear Tag

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).

On 10-May-2019, two, approximately 2 month old, bovine, of unknown signalment and condition, with no known concomitant medical conditions, had 1 Corathon (Coumaphos Diazinon) ear tag placed in an ear by the owner. The calves was also administered doramectin, Moraxella bovis vaccine, infectious bovine rhinotracheitis virus, bovine diarrhea virus Types 1 and 2, parainfluenza 3 virus and bovine respiratory vaccine, Clostridium Chauvoei, Septicum, Novyi, Sordellii, Perfringens Type CD vaccine, and ivermectin pour on.

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

Cow / Vache

3. Breed

Other Bovine/cattle

4. Number of animals affected

2

5. Sex

Unknown

6. Age (provide a range if necessary )

0.16

7. Weight (provide a range if necessary )

Unknown

8. Route(s) of exposure

Skin

9. What was the length of exposure?

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

10. Time between exposure and onset of symptoms

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

11. List all symptoms

System

  • General
    • Symptom - Lethargy
  • Respiratory System
    • Symptom - Laboured breathing
  • Nervous and Muscular Systems
    • Symptom - Recumbent
  • General
    • Symptom - Death

12. How long did the symptoms last?

Unknown / Inconnu

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

Unknown

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

Approximately 2 hours post application, the cattle exhibited lethargy, labored breathing and lateral recumbency. The cattle were examined by a veterinarian; it was unknown if treatments were provided. On approximately 12May2019, one of the calves died. It was unknown if a necropsy was performed. On 13May2019, the other calf died. It was unknown if a necropsy was performed. No further information is expected; this case is closed.


To be determined by Registrant

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

Death

19. Provide supplemental information here

O - Unclassifiable/unassessable Time to onset and clinical signs may be indicative for an anaphylactic reaction. But clinical course is not consistent. Also, the successful treatment of an allergic reaction appears possible. It is highly unlikely that clinical signs and death was associated with the application of the ear tag, but current knowledge is not sufficient to exclude product involvement with the necessary certainty. (O)