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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2019-2344

2. Registrant Information.

Registrant Reference Number: USA-BAYERBAH-2019-US0017226 (Report 559034)

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.

26-APR-19

5. Location of incident.

Country: UNITED STATES

Prov / State: FLORIDA

6. Date incident was first observed.

06-MAR-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. 27586      PMRA Submission No.       EPA Registration No. 11556-152

Product Name: Advantage Plus Spot-on 0.8 ml (80 mg Imi / 4 mg Pyri) Cat > 4 kg

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

7. b) Type of formulation.

Liquid

Application Information

8. Product was applied?

Yes

9. Application Rate.

.8

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 an unknown date in 2017, an 11 year old, 12 pound, neutered, female, feline, of an unknown breed and condition, with concomitant medical conditions of diabetes and excessive grooming, that is on an unknown dose of an unknown insulin every 12 hours since 2016, was administered 1 tube of Advantage Multi for Cats (10% imidacloprid + 1% moxidectin) Topical Solution 0.8 mL topically by the owner. On 06Mar2019, the then 13 year old feline had visible fleas and scabies. On 10Mar2019, the feline was also administered 1 tube of Advantage II Large Cat(Imidacloprid-Pyriproxyfen) topically by the owner. On 19Mar2019, the feline was administered 1 tube of Advantage Multi for Cats (10% imidacloprid + 1% moxidectin) Topical Solution 0.8 mL topically by the owner. The fleas continued unchanged.

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

Cat / Chat

3. Breed

Unknown

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

11

7. Weight (provide a range if necessary )

5.44

kg

8. Route(s) of exposure

Skin

9. What was the length of exposure?

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

10. Time between exposure and onset of symptoms

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

11. List all symptoms

System

  • General
    • Symptom - Parasitism
  • Skin
    • Symptom - Hair loss
  • General
    • Symptom - Death

12. How long did the symptoms last?

Persisted until death

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

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 01Apr2019, the feline developed alopecia on her abdomen. On 05Apr2019, the feline was administered her insulin injection and then was administered 1 dose of Advantage Multi for Cats (10% imidacloprid + 1% moxidectin) Topical Solution 0.8 mL topically by the owner. This is an off label use of the product do to the frequency of application. Approximately 10 hours post application, the feline died. No known necropsy was performed. No more information is expected. The 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 Scabies and initially observed fleas are reported before product application hence not product related. Alopecia on other than the application site is not anticipated with topical product administration. If any, skin reactions would be localized at the application site. Further, continuation of the fleas after product application is not a sign of inefficacy. Regular treatments for at least a 6-week period are necessary in order to break the flea development circle. Otherwise preexisting pupae may still emerge from the environment and re-infest the pet. Efficacy against fleas can be expected only after this period. Further, death is not expected after topical product application as inconsistent with pharmaco-toxicological product profile and experience. Product has wide margin of safety. Oral LD50 in rat is 642 mg/kg BW. 24-fold overdosage tolerated by cats without showing any side effect. Other causes (e.g. concomitant medical condition of diabetes) must be considered in this geriatric animal. Time to onset is long. Considering overall aspects, a product relation is unlikely.