Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2016-4262

2. Registrant Information.

Registrant Reference Number: 2016KP143

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.

18-JUL-16

5. Location of incident.

Country: UNITED STATES

Prov / State: UNKNOWN

6. Date incident was first observed.

13-OCT-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)

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PMRA Registration No.       PMRA Submission No.       EPA Registration No. 11556-155

Product Name: Seresto Collar - Cat

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

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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 23-Sep-2015, a 1 year old, intact, male, Persian feline, of unknown weight, in poor condition, was examined by the attending veterinarian. The cat was diagnosed with colitis,fleas, roundworms and coccidia. It had a Seresto Cat collar(Flumethrin-Imidacloprid) placed around its neck by the attending veterinarian. 1 tube of Profender(emodepside/praziquantel) was also applied topically by the attending veterinarian. It was also started on an unknown regimen of metronidazole orally via an unknown route 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

Cat / Chat

3. Breed

Persian

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

1

7. Weight (provide a range if necessary )

Unknown

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 - Bloody vomit

• Cardiovascular System
  • Symptom - Cardiac arrest

• Respiratory System
  • Symptom - Respiratory distress

• General
  • Symptom - Lethargy

• Gastrointestinal System
  • Symptom - Diarrhea
  • Symptom - Vomiting
  • Symptom - Salivating excessively
  • Symptom - Drooling
  • Symptom - Anorexia

• General
  • Symptom - Adipsia

• Gastrointestinal System
  • Symptom - Bloody diarrhea

12. How long did the symptoms last?

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

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

Yes

14. a) Was the animal hospitalized?

Yes

14. b) How long was the animal hospitalized?

2

Day(s) / Jour(s)

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 13 Oct 2015, the feline had liquid diarrhea. On 14 Oct 2015, the feline vomited several times. It was fed water through a syringe orally by the owner and would drool and foam at the mouth after administration of the water. The diarrhea continued. The feline was examined by the attending veterinarian. Unknown tests were performed and they were within normal limits. The feline was hospitalized. It was administered an unknown dose of maropitant citrate . The Seresto collar was tightened by the attending veterinarian but the cat continued to have fleas. On 15 Oct 2015, the feline continued to vomit and have diarrhea. It behaved quieter than normal (lethargy). The collar was removed by the attending veterinarian. The cat remained hospitalized but treatments were not specified. On 16 Oct 2015, a fecal exam was positive for coccidia, and the feline was started on an unknown dose of sulfadimethoxine orally by the attending veterinarian. The feline was not eating or drinking and developed bloody diarrhea and blood was also present in the cat's vomitus. The feline developed cardiac and respiratory arrest and died. Follow up information received on 31st may 2016 : No known necropsy was performed. No further information expected. Case closed.

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To be determined by Registrant

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

Death

19. Provide supplemental information here

Digestive signs are unspecific and may have numerous other causes (e.g. gastrointestinal infection, dietary incompatibility and concomitant conditions). No oral product exposure. Reported systemic signs are unspecific, however in this case these are likely consequence of digestive disorders. Adipsia is not expected however, it is likely associate with anorexia. Serious signs like cardiac and respiratory arrest are not expected after topical application of the product. Death is not expected following appropriate topical product application as inconsistent with products pharmacological profile. Oral exposure to the collar is not expected to cause death either. No signs of anaphylaxis reported which would have occurred in close proximity to the collar application. Death was the consequence of serious signs (cardiac and respiratory arrest), moreover serious signs were observed after removal of collar. Considering the safety profile of the product, very long time to onset and though no necropsy was done sufficient information exists to rule out product involvement and relation remains unlikely.