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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2016-0731

2. Registrant Information.

Registrant Reference Number: 2015KP358

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.

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. 11556-155

Product Name: Seresto Collar

  • Active Ingredient(s)
    • Flumethrin
    • IMIDACLOPRID
      • Guarantee/concentration 10 %

7. b) Type of formulation.

Other (specify)

collar

Application Information

8. Product was applied?

Yes

9. Application Rate.

1

Other Units: collar

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 unspecified date in Sep-2015, a 7 year old, 20 pound,neutered, male, Pomeranian canine, in good condition with a concomitant medical condition of an ear infection treated with an unspecified ear medication, had 1 Seresto Large Dog(Flumethrin-Imidacloprid) collar placed around the neck 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

Other

2. Type of animal affected

Dog / Chien

3. Breed

Pomeranian

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

7

7. Weight (provide a range if necessary )

20

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

>24 hrs <=3 days / >24 h <=3 jours

11. List all symptoms

System

  • General
    • Symptom - Death
  • Gastrointestinal System
    • Symptom - Weight loss
  • General
    • Symptom - Abnormal behaviour
    • Specify - Behavioural disorder
  • Skin
    • Symptom - Pruritus
  • Gastrointestinal System
    • Symptom - Anorexia
  • General
    • Symptom - Adipsia
    • Symptom - Malaise
  • Gastrointestinal System
    • Symptom - Other
    • Specify - Anal sac disorder
  • Nervous and Muscular Systems
    • Symptom - Ataxia
  • General
    • Symptom - Other
    • Specify - Abnormal test results
  • Renal System
    • Symptom - Other
    • Specify - Renal Insufficiency

12. How long did the symptoms last?

<=30 min / <=30 min

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

Immediately post application, the dog exhibited a behavior change and generalized pruritus. On approximately 15-Oct-2015, the dog exhibited anorexia, adipsia, and malaise. On approximately 20-Oct-2015, the dog was examined by a veterinarian and had full anal sacs; which were expressed. On 22-Oct-2015, the dog couldn't walk. The collar was removed. The dog was examined by a veterinarian and had a blood profile performed. The kidney and pancreatic function tests were abnormally elevated. The dog was diagnosed with renal disease. The dog was administered subcutaneous fluids and furosemide injectable. The dog weighed 16 pounds. On 23-Oct-2015 the dog was able to walk again. The dog was administered subcutaneous fluids and furosemide injectable at home. Follow-up received on 11 th Nov 2015: The dog died at home that same day. No necropsy was performed.


To be determined by Registrant

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

Death

19. Provide supplemental information here

Reported behavioural change is an unspecific sign and may have various other causes in a dog. Generalized pruritus is not typically seen with topical product administration. If any, skin reaction would be localized at the application site. Time to onset is very short for these reported signs. Further reported anorexia, adipsia, malaise and walking difficulty are unspecific signs and not expected after collar application and time to onset of signs is too long with more than two weeks. Signs might be linked to the further diagnosed renal disease. Anal sac disorder is not expected to be product related and is likely only a concomitant finding. Reported elevation in kidney and pancreatic function tests, weight loss and especially death are not expected after product application as they are inconsistent with the pharmaco-toxicological product profile. An oral exposure to the collar is not expected to cause death either. Moreover, these signs were reported after collar removal. Death likely consequence of renal disease. Finally, even though necropsy was not performed and time to onset for initial signs is short, considering all available information, chronology and long time to onset for further reported signs, the products pharmaco-toxicological profile and the fact that an alternative cause was identified, a product relation is deemed to be unlikely.