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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2018-5498

2. Registrant Information.

Registrant Reference Number: USA-BAYERBAH-2018-US0047160 (Report 512859)

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.

14-AUG-18

5. Location of incident.

Country: UNITED STATES

Prov / State: UNKNOWN

6. Date incident was first observed.

Unknown

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. 11556-152

Product Name: Advantage II Large Cat

  • 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.

.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 approximately 2017, a 12 year old, 12 pound, male, feline, of an unknown reproductive status, breed, and condition, with no known concomitant medical conditions, was administered 1 tube of Advantage II Large Cat (Imidacloprid-Pyriproxyfen) topically by the owner. On an unspecified date in 2018, the feline was administered 1 tube of Advantage II (cat-unspecified) (Imidacloprid-Pyriproxyfen) topically by the owner.

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

Male

6. Age (provide a range if necessary )

12

7. Weight (provide a range if necessary )

5.443

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

>8 hrs <=24 hrs / > 8 h < = 24 h

11. List all symptoms

System

  • Skin
    • Symptom - Hair loss
    • Symptom - Lesion
    • Symptom - Pruritus
  • 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

Approximately 1 day post application in 2018, the cat exhibited application site alopecia and application site lesion. Two months post application in 2018, the cat exhibited generalized alopecia and died. No necropsy was performed. No further information is expected. This case is closed. Follow up received on 21st Aug 2018: Approximately 1 day post application in 2018, the cat exhibited application site alopecia and application site lesion. Two months post application in 2018, the cat exhibited generalized alopecia and died. No necropsy was performed. Due to the nature of the communication and in order to avoid further strain on the relationship with the reporting party, no further information will be sought. No further information is expected. Case is closed. Note: No quality issues were noted upon product investigation.


To be determined by Registrant

18. Severity classification (if there is more than 1 possible classification

Death

19. Provide supplemental information here

O - Unclassifiable/unassessable Pruritus is not expected with appropriate topical product use. If any, skin reactions would be located at the application site. Skin disorders in this case rather associated with current flea infestation. However, presence of fleas 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. Moreover, in this case time to onset is unknown however likely more than 4 weeks, the claimed efficacy period. A dermal reaction at the application site in a particularly sensitive animal may occur. Alopecia on other than the application site is not anticipated with topical product administration. Death is 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. Furthermore the cat involved in this case was geriatric. Time to onset post re-application for application site disorders was short however long for other reported signs. Considering some information (e.g. state of heath, product details and necropsy results) missing, an overall product relation is unassessable.