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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2015-3856

2. Registrant Information.

Registrant Reference Number: 2015KP167

Registrant Name (Full Legal Name no abbreviations): Bayer Inc

Address: 2920 Matheson Boulevard

City: Missisaugua

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.

05-AUG-15

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 - Large Dog

  • 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 approximately 01Oct2013, a 13 year old, 38.00 pound, neutered, male, Jack Russell Terrier canine, in good condition, with a current flea infestation, had 1 Seresto Large Dog collar (Flumethrin-Imidacloprid) placed around his neck by the owner. Follow-up information of 06.03.2014: On approximately 01-Feb-2013, a 13 year old, 38.00 pound, neutered, male, Jack Russell Terrier canine, in good condition, with a current flea infestation, had 1 Seresto Large Dog collar (Flumethrin-Imidacloprid) placed around his 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

Jack Russell Terrier

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

13

7. Weight (provide a range if necessary )

38

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

Unknown / Inconnu

11. List all symptoms

System

  • General
    • Symptom - Death
  • Skin
    • Symptom - Lesion
    • Symptom - Erythema

12. How long did the symptoms last?

Unknown / Inconnu

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

At an undetermined time post application the patient developed an application site lesion and erythema at the application site. It is not known if the collar was removed. The patient then passed away on an unknown date. Further details about the cause of death were declined. A necropsy was not performed.Follow-up information of 06.03.2014:At an undetermined time post application the patient developed an application site lesion and erythema at the application site. The collar was removed at an unknown time.The dog had an unknown size of Advantage II Canine (Imidacloprid-Pyriproxyfen) applied to it topically at an unknown time. On an unknown date in March 2013 the patient passed away. Further details about the cause of death were declined. A necropsy was not performed. No more information is expected. MAH comment: The caller contacted Bayer Animal Health to inquire about the product use on other pets and not to report this event.


To be determined by Registrant

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

Death

19. Provide supplemental information here

N - Unlikely. Transient mild application site disorders may occur in particularly sensitive animals shortly after product application. Application site signs consistent with pharmaco-toxicological product profile. However, in this case, time to onset unknown. Death however would not be expected following use of the product; even not following oral ingestion or overdose. Signs are not consistent with pharm-tox product profile. Although product may have caused the application site reaction, product involvement of death was considered rather unlikely, even though circumstances of death not reported. No necropsy was performed. According to case description, collar was removed a certain time before death occurred. It must be also considered that the caller contacted Bayer Animal Health to inquire about the product use on other pets and not to report this event. In the end, product involvement on death considered unlikely