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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2020-4865

2. Registrant Information.

Registrant Reference Number: 2020-US-18556

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.

01-OCT-20

5. Location of incident.

Country: UNITED STATES

Prov / State: UNKNOWN

6. Date incident was first observed.

01-SEP-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).

Case originates from a post authorization study: MS-Nasalgen 3-03-19. On 25 Sept 2020, the study investigator reported that on 25 Sept 2020, a control calf, not vaccinated with Bovilis Nasalgen 3, presented with a lump on its hind leg and was non-weight bearing. The lump was firm and fibrotic. The attending veterinarian aspirated the lump and was only able to remove some blood. The calf was possibly treated with flunixin meglumine. It is unknown if the product used was Banamine. The calf was euthanized and necropsy showed the infection was in the tendon with evidence of joint communication. Lungs were clear and fecal samples revealed giardia and rota. No further follow up expected. Follow up Case updated to Suspected Adverse Reaction (SAR): On 1 Oct 2020, the study investigator reported that the calf was not treated with Banamine but was treated with Ultra Boss on 14 Sept 2020 and had been previously treated on 30 Jun 2020, 13 Jul 2020 and 11 Aug 2020. Around 25 Sept 2020, the calf was euthanized due to a lump on its hind leg and the leg not being non-weight bearing which did not respond to treatment by the veterinarian. 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

>2 mos <=6 mos / > 2 mois < = 6 mois

11. List all symptoms

System

  • General
    • Symptom - Other
    • Specify - lump on its hind leg, firm and fibrotic
    • Symptom - Other
    • Specify - non weight bearing
    • Symptom - Other
    • Specify - infection was in the tendon with evidence of joint communication on necropsy

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

Euthanised / Euthanasie

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

Case originates from a post authorization study: MS-Nasalgen 3-03-19. On 25 Sept 2020, the study investigator reported that on 25 Sept 2020, a control calf, not vaccinated with Bovilis Nasalgen 3, presented with a lump on its hind leg and was non-weight bearing. The lump was firm and fibrotic. The attending veterinarian aspirated the lump and was only able to remove some blood. The calf was possibly treated with flunixin meglumine. It is unknown if the product used was Banamine. The calf was euthanized and necropsy showed the infection was in the tendon with evidence of joint communication. Lungs were clear and fecal samples revealed giardia and rota. No further follow up expected. Follow up Case updated to Suspected Adverse Reaction (SAR): On 1 Oct 2020, the study investigator reported that the calf was not treated with Banamine but was treated with Ultra Boss on 14 Sept 2020 and had been previously treated on 30 Jun 2020, 13 Jul 2020 and 11 Aug 2020. Around 25 Sept 2020, the calf was euthanized due to a lump on its hind leg and the leg not being non-weight bearing which did not respond to treatment by the veterinarian. 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