Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2020-5288
2. Registrant Information.
Registrant Reference Number: 2020-US-20169
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.
20-OCT-20
5. Location of incident.
Country: UNITED STATES
Prov / State: UNKNOWN
6. Date incident was first observed.
04-OCT-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. 773-84
Product Name: UltraBoss
- Active Ingredient(s)
- PERMETHRIN
- Guarantee/concentration 5 %
- PIPERONYL BUTOXIDE
- Guarantee/concentration 5 %
7. b) Type of formulation.
Liquid
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).
Suspected Adverse Reaction and Extra Label Use (ELU): Case originates from a post authorization study: MS-Nasalgen 3-03-19. On 20 Oct 2020, the study investigator reported that on 05 Oct 2020, a control calf, not vaccinated with Bovilis Nasalgen 3, was found dead. The calf had displayed clinical signs of respiratory disease on 04 Oct 2020. The calf had been treated with Ultra Boss on 14 Sept 2020 and had been previously treated on 30 Jun 2020, 13 Jul 2020 and 11 Aug 2020 (ELU- frequency too high). The calf had been challenged with BRSV per study protocol and upon necropsy showed significant lesions in the lungs typical of BRSV and bronchointerstitial pneumonia. No further follow up expected.
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
Other
2. Type of animal affected
Cow / Vache
3. Breed
Holstein
4. Number of animals affected
1
5. Sex
Male
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?
<=15 min / <=15 min
10. Time between exposure and onset of symptoms
>1 wk <=1 mo / > 1 sem < = 1 mois
11. List all symptoms
System
- Respiratory System
- Symptom - Other
- Specify - Significant lesions in the lungs at necropsy typical of BRSV and bronchointerstitial pneumonia.
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
Suspected Adverse Reaction and Extra Label Use (ELU): Case originates from a post authorization study: MS-Nasalgen 3-03-19. On 20 Oct 2020, the study investigator reported that on 05 Oct 2020, a control calf, not vaccinated with Bovilis Nasalgen 3, was found dead. The calf had displayed clinical signs of respiratory disease on 04 Oct 2020. The calf had been treated with Ultra Boss on 14 Sept 2020 and had been previously treated on 30 Jun 2020, 13 Jul 2020 and 11 Aug 2020 (ELU- frequency too high). The calf had been challenged with BRSV per study protocol and upon necropsy showed significant lesions in the lungs typical of BRSV and bronchointerstitial pneumonia. No further follow up expected.
To be determined by Registrant
18. Severity classification (if there is more than 1 possible classification
Death
19. Provide supplemental information here