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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2020-2822

2. Registrant Information.

Registrant Reference Number: USA-BAYERBAH-2020-US0025572 (Report 641256)

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.

03-JUN-20

5. Location of incident.

Country: UNITED STATES

Prov / State: UNKNOWN

6. Date incident was first observed.

30-MAY-20

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. 11556-115

Product Name: CO-RAL Fly and Tick Spray

  • Active Ingredient(s)
    • Coumaphos
      • Guarantee/concentration 6.15 %

7. b) Type of formulation.

Other (specify)

Spray

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).

On 29-May-2020, 88, intact, mixed sex, Crossbred bovine, of unknown age and weight, in unknown condition, with no known concomitant medical conditions, were each administered an unknown amount of Co-Ral Fly Tick Spray (Coumaphos) topically by the owner. The dilution rate was 2.5 ounces per 2 gallons of water.

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

Cow / Vache

3. Breed

Crossbred (Cattle)

4. Number of animals affected

5

5. Sex

Male

Female

6. Age (provide a range if necessary )

Unknown

7. Weight (provide a range if necessary )

Unknown

8. Route(s) of exposure

Skin

9. What was the length of exposure?

>3 days <=1 wk / >3 jours <=1 sem

10. Time between exposure and onset of symptoms

>8 hrs <=24 hrs / > 8 h < = 24 h

11. List all symptoms

System

  • Nervous and Muscular Systems
    • Symptom - Ataxia
  • General
    • Symptom - Death
    • Symptom - Other
    • Specify - Autolysis

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

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 30May2020, 6 heifers exhibited ataxia. One of the affected heifers died. On 01Jun2020, The 5 affected heifers were examined and treated with an unspecified dose of atropine. On 02Jun2020, the 5 heifers exhibiting ataxia and died and 1 additional heifer died without signs of ataxia. No necropsy examination had been performed. On 03Jun2020, an unknown number of the deceased heifers were necropsied. Tissue samples were collected for histological and bacterial testing. The results were unknown. On 19Jun2020, gross pathology and histopathology of lung and tissue samples submitted from one of the deceased animals revealed marked autolysis (other abnormal test result NOS). No further information is expected. This case is closed. SLEE


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 Ataxia and death are not expected after topical administration of appropriate spraying solution as absorption rate through the intact skin is low. Reported diltution rate was according to label however unknown how much spray actually was applied. Signs may occur after an organophosphat toxicosis, however the course of an organophosphate poisoning is peracute to acute. Time to onset rather long in this case and no other typical signs of an organophosphate poisining (hypersalivation, miosis, diarrhoea, dyspnoea) reported. Antidote treatment did not improve situation. One heifer actually died without showing ataxia. Necropsy was performed but results unspecific and did not reveal further information. Due to limited or inconclusive information a relation to product is considered unassessable.

Subform III: Domestic Animal Incident Report

1. Source of Report

Animal's Owner

2. Type of animal affected

Cow / Vache

3. Breed

Crossbred (cattle)

4. Number of animals affected

1

5. Sex

Unknown

6. Age (provide a range if necessary )

Unknown

7. Weight (provide a range if necessary )

Unknown

8. Route(s) of exposure

Skin

9. What was the length of exposure?

>8 hrs <= 24 hrs / >8 h <= 24 h

10. Time between exposure and onset of symptoms

>8 hrs <=24 hrs / > 8 h < = 24 h

11. List all symptoms

System

  • General
    • Symptom - Death
  • 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.

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


To be determined by Registrant

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

Not Applicable

19. Provide supplemental information here

Subform III: Domestic Animal Incident Report

1. Source of Report

Animal's Owner

2. Type of animal affected

Cow / Vache

3. Breed

Crossbred cattle

4. Number of animals affected

1

5. Sex

Unknown

6. Age (provide a range if necessary )

Unknown

7. Weight (provide a range if necessary )

Unknown

8. Route(s) of exposure

Skin

9. What was the length of exposure?

>3 days <=1 wk / >3 jours <=1 sem

10. Time between exposure and onset of symptoms

>3 days <=1 wk / >3 jours <=1 sem

11. List all symptoms

System

  • General
    • Symptom - Death

12. How long did the symptoms last?

Unknown / Inconnu

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


To be determined by Registrant

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

Not Applicable

19. Provide supplemental information here