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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2017-2168

2. Registrant Information.

Registrant Reference Number: 2017KP112

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.

19-APR-17

5. Location of incident.

Country: UNITED STATES

Prov / State: UNKNOWN

6. Date incident was first observed.

30-DEC-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 28-Dec-2015, an approximately 12.5 year old, 7.2 pound,neutered, female, Domestic Shorthair feline, in unknown condition, with no known concomitant medical conditions,exhibited bleeding from her right ear. On 30-Dec-2015, the feline was examined by a veterinarian. A tumor was diagnosed in the right ear and the feline was started on a otic nystatin, neomycin, thiostrepton,triamcinolone ointment. On 13-Jan-2016, the feline was re-examined and the bleeding had resolved. On an unknown date in 2016, the owner accidentally instilled1 tube of Advantage II Small Cat (Imidacloprid-Pyriproxyfen)into the right ear by the owner. The product was wiped out ofthe ear and followed by administration of a ivermectin inglycol ear ointment.

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

Domestic Shorthair

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

12.5

7. Weight (provide a range if necessary )

7.2

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

Unknown / Inconnu

11. List all symptoms

System

  • General
    • Symptom - Death
  • Nervous and Muscular Systems
    • Symptom - Other
    • Specify - Neurological disorder
  • Ear
    • Symptom - Other
    • Specify - Aural neoplasia
  • Nervous and Muscular Systems
    • Symptom - Ataxia
  • Gastrointestinal System
    • Symptom - Anorexia
  • General
    • Symptom - Discomfort
  • Skin
    • Symptom - Other
    • Specify - Application site haemorrhage
    • Symptom - Other
    • Specify - Application site serous discharge

12. How long did the symptoms last?

Persisted until death

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 11-Jun-2016, the feline was examined for unspecified neurological signs. No known treatments were performed. On 14-Jun-2016, the feline was examined by the veterinarian. The tumor in the right ear had increased in size, was glistening and had vast vascular network. A tumor was diagnosed in the left ear. No known treatments were performed. On 22-Jun-2016, the feline was re-examined by the veterinarian. No known treatments were performed. On 05-Jul-2016, the feline was examined, but no treatments were performed. On approximately 06-Jul-2016, the feline exhibited ataxia, circling, anorexia, and discomfort. On 13-Jul-2016, the feline was examined. The right ear tumor was bleeding, quiescent, with slight discharge. A nystatin, neomycin, thiostrepton, triamcinolone ointment was instilled in the ears by the attending vet. On an unknown date in Jul2016, the feline was examined by a veterinary neurologist. No known treatments were performed. On 21-Jul-2016, the feline died. No necropsy was performed. No further information is expected. This case is closed. Follow-up received on 15th March 2017: On 13-Jul-2016, the feline was examined. The right ear tumor had not changed in size but was bleeding and had a slight discharge.


To be determined by Registrant

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

Death

19. Provide supplemental information here

Off label use of the product as product was administered in ear. Initially reported unspecified neurological signs are not anticipated with appropriate topical product administration. Even with oral product exposure which was not reported only transient gastrointestinal signs but no neurological signs would be expected. Worsening of pre-existing tumor and diagnosed tumor in another ear is not expected after product administration as not in line with pharmaco toxicological product profile. Later observed neurological signs, anorexia and discomfort likely associated with reported tumor in ears. Reported application site disorders are not expected after appropriate product administration, moreover in this case reported application site disorders associated with worsening of ear tumor. Death is inconsistent with pharmaco-toxicological product profile and experience. No signs of allergic/anaphylactic reaction reported. 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. Animal involved in this case was geriatric and had concomitant condition of tumor which may have further contributed to the death of the animal. Time to onset is unknown for initial reported signs but it is too long for later observed signs. In case of suspected product involvement adverse event would have been reported in close proximity not long time after (almost 7 months later). Even though some information is not available (animal health status and necropsy report), sufficient information exists to rule out product relation completely. Overall, a product relation is consider as unlikely.