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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2018-3580

2. Registrant Information.

Registrant Reference Number: USA-BAYERBAH-2018-US0041186 (Report 507890)

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.

24-JUL-18

5. Location of incident.

Country: UNITED STATES

Prov / State: NORTH CAROLINA

6. Date incident was first observed.

10-MAY-18

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. 11556-150

Product Name: Advantage II Kitten

  • Active Ingredient(s)
    • IMIDACLOPRID
      • Guarantee/concentration 9.1 %
    • PYRIPROXYFEN
      • Guarantee/concentration .46 %

7. b) Type of formulation.

Other (specify)

Spot-on

Application Information

8. Product was applied?

Yes

9. Application Rate.

.23

Units: mL

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 approximately 28-Apr-2018, an 8 year old, 10 pound, neutered, female, Rex rabbit, in unknown condition, with no known concomitant medical conditions, was administered 1 tube of Advantage II Kitten (Imidacloprid-Pyriproxyfen) topically by the owner. This is an off-label use of the product by species. The rabbit continued to be administered 1 tube of Advantage II Kitten (Imidacloprid-Pyriproxyfen) topically by the owner every month, with the most recent dose being approxinately 28-Jun-2018.

To be determined by Registrant

12. In your opinion, was the product used according to the label instructions?

No

Subform III: Domestic Animal Incident Report

1. Source of Report

Animal's Owner

2. Type of animal affected

Other / Autre

specify Rabbit

3. Breed

Rex

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

8

7. Weight (provide a range if necessary )

4.563

kg

8. Route(s) of exposure

Skin

9. What was the length of exposure?

>1 mo <= 6 mos / > 1 mois < = 6 mois

10. Time between exposure and onset of symptoms

>1 wk <=1 mo / > 1 sem < = 1 mois

11. List all symptoms

System

  • Gastrointestinal System
    • Symptom - Weight loss
    • Symptom - Anorexia
  • General
    • Symptom - Death

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

On approximatley 10-May-2018, the rabbit demonstrated decreased appetite. The rabbit continued to be administered 1 tube of Advantage II Kitten (Imidacloprid-Pyriproxyfen) topically by the owner every month, with the most recent dose being approxinately 28-Jun-2018. On approxinately 22-Jul-2018, the rabbit was found dead. Fleas were present on the rabbit and his weight was approximately 4.5 pounds. No necropsy was performed. No furhter 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

N - Unlikely Off label use of the product as product is not indicated for rabbit. Reported anorexia is unspecific and may have numerous other causes. Weight loss is not anticipated after topical product application. It is not consistent with pharmaco-toxicological product profile. Other causes are more likely in this 8-years old rabbit. Further, death is inconsistent with pharmaco-toxicological product profile and experience. No signs of allergic/anaphylactic reaction reported. Product has wide margin of safety. Oral LD50 in rat is 642 mg/kg BW. 24-fold overdosage tolerated by cats and 20-fold overdosage tolerated by dogs without showing any side effect. Fatal outcome more likely related to underlying disease in this 8-year old rabbit. Fleas were only reported after the rabbit died, which is unusual. Product is not a repellent. In this case, the previous exposure was well tolerated by the animal. Time to onset is long. Although, no necropsy was performed, considering all aspects, a product involvement is unlikely.