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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2016-3537

2. Registrant Information.

Registrant Reference Number: 2016KP020

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.

15-JAN-16

5. Location of incident.

Country: UNITED STATES

Prov / State: UNKNOWN

6. Date incident was first observed.

10-NOV-15

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. 11556-151

Product Name: advantage II small cat

  • 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.

.4

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 31-Oct-2015, a 22 year old, 9 pound, neutered, male,Domestic Shorthair feline, in good condition, with no known concomitant medical conditions, was administered 1 tube of Advantage II Small Cat (Imidacloprid-Pyriproxyfen) topically by the owner.

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

Other

2. Type of animal affected

Cat / Chat

3. Breed

Domestic Shorthair

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

22

7. Weight (provide a range if necessary )

9

lbs

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

12. How long did the symptoms last?

>1 mo and <= 2mos / >1 mois et < = 2mois

13. Was medical treatment provided? Provide details in question 17.

Yes

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 10 Nov 2015, the cat exhibited weight loss. On 15 Nov 2015, the cat continued to lose weight, was examined by a veterinarian, and diagnosed with a abdominal tumor. The cat was placed on an unknown amount of oral buprenorphine as needed for pain. On 22 Dec 2015, the cat had anorexia. On 17 Jan 2016, the owner administered 2 doses of buprenorphine, sublingual. The cat died at home approximately 4 hours post administration of buprenorphine. No necropsy was performed. No more information is expected. This case is closed. Note: Previous application is well tolerated by the cat.


To be determined by Registrant

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

Death

19. Provide supplemental information here

Weight loss is not expected after product application as inconsistent with pharmaco toxicological product profile. In this case it may be related to later diagnose abdominal tumor. Anorexia is unspecific and may be related to the abdominal tumor. Abdominal tumor and death are also not expected after product application, as inconsistent with pharmaco-toxicological product profile. No signs of allergic/anaphylactic reaction reported. Product has wide margin of safety. Oral LD50 in rat 642 mg/kg BW. 24-fold overdosage tolerated by cats without showing any side effect. Cat likely died due to underlying medical condition of abdominal tumor and of an old age. Additionally, previous exposure is well tolerated by the cat. Time to onset is long. Finally, even though some information (e.g. necropsy results) missing, considering known product profile and fetal outcome, a product involvement is deemed to be unlikely.