Incident Report
Subform I: General Information
1. Report Type.
Update the report
Incident Report Number: 2020-0198
2. Registrant Information.
Registrant Reference Number: 2018-US-21644
Registrant Name (Full Legal Name no abbreviations): Merck Animal Health (Intervet Canada Corp)
Address: 16750 Transcanada Highway
City: Kirkland
Prov / State: Quebec
Country: Canada
Postal Code: H9H 4M7
3. Select the appropriate subform(s) for the incident.
Domestic Animal
4. Date registrant was first informed of the incident.
08-NOV-19
5. Location of incident.
Country: UNITED STATES
Prov / State: UNKNOWN
6. Date incident was first observed.
02-NOV-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. 773-92
Product Name: Ultra Saber Pour On
- Active Ingredient(s)
- LAMBDA-CYHALOTHRIN
- Guarantee/concentration 1 %
- PIPERONYL BUTOXIDE
- Guarantee/concentration 5 %
7. b) Type of formulation.
Liquid
Application Information
8. Product was applied?
Yes
9. Application Rate.
15
Other Units: ml/600lbs
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).
Suspected Adverse Reaction: On 8 Nov 2019 a veterinarian reported that one of his clients vaccinated 350 bred heifers on 01 Nov 2019 with Guardian and Preg Guard 10. The heifers were pregnancy checked, poured with Ultra Saber and Drenched with Safeguard Suspension. Within 48 hours the producer had seen 7 heifers abort and 1 heifer that died while aborting. The producer was going to try and collect any fresh abortions that may happen and send them in for testing. Further follow-up is expected.
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
Animal's Owner
2. Type of animal affected
Cow / Vache
3. Breed
Angus
4. Number of animals affected
1
5. Sex
Female
6. Age (provide a range if necessary )
1.6
7. Weight (provide a range if necessary )
1100
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
- Reproductive System
- Symptom - Miscarriage
- Specify - abortion
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
Suspected Adverse Reaction: On 8 Nov 2019 a veterinarian reported that one of his clients vaccinated 350 bred heifers on 01 Nov 2019 with Guardian and Preg Guard 10. The heifers were pregnancy checked, poured with Ultra Saber and Drenched with Safeguard Suspension. Within 48 hours the producer had seen 7 heifers abort and 1 heifer that died while aborting. The producer was going to try and collect any fresh abortions that may happen and send them in for testing. Further follow-up is expected.
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
Animal's Owner
2. Type of animal affected
Cow / Vache
3. Breed
Angus
4. Number of animals affected
5. Sex
Female
6. Age (provide a range if necessary )
1.6
7. Weight (provide a range if necessary )
1100
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
- Reproductive System
- Symptom - Miscarriage
- Specify - abortion
12. How long did the symptoms last?
>3 days <=1 wk / >3 jours <=1 sem
13. Was medical treatment provided? Provide details in question 17.
Unknown
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
Suspected Adverse Reaction: On 8 Nov 2019 a veterinarian reported that one of his clients vaccinated 350 bred heifers on 01 Nov 2019 with Guardian and Preg Guard 10. The heifers were pregnancy checked, poured with Ultra Saber and Drenched with Safeguard Suspension. Within 48 hours the producer had seen 7 heifers abort and 1 heifer that died while aborting. The producer was going to try and collect any fresh abortions that may happen and send them in for testing. Further follow-up is expected.
To be determined by Registrant
18. Severity classification (if there is more than 1 possible classification
Not Applicable
19. Provide supplemental information here