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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2017-7483

2. Registrant Information.

Registrant Reference Number: USA-BAYERBAH-2017-US0067345 (Report 453563)

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

Address: 2920 Matheson BLVD

City: Mississaugua

Prov / State: ON

Country: Canada

Postal Code: L5W5R6

3. Select the appropriate subform(s) for the incident.

Domestic Animal

4. Date registrant was first informed of the incident.

13-OCT-17

5. Location of incident.

Country: UNITED STATES

Prov / State: DELAWARE

6. Date incident was first observed.

12-OCT-17

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 %

PMRA Registration No.       PMRA Submission No.       EPA Registration No. 11556-143

Product Name: K9 Advantix II Large Dog

  • Active Ingredient(s)
    • IMIDACLOPRID
      • Guarantee/concentration 8.8 %
    • PERMETHRIN
      • Guarantee/concentration 44 %
    • PYRIPROXYFEN
      • Guarantee/concentration .44 %

7. b) Type of formulation.

Other (specify)

Spot-on

Application Information

8. Product was applied?

Yes

9. Application Rate.

2.5

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).

A 3 year old, 7 pound, neutered, female, Domestic Shorthair feline, in unknown condition, with no known concomitant medical conditions, was administered 1 tube of Advantage II Small Cat (Imidacloprid-Pyriproxyfen) topically by the owner. On 12-Oct-2017, the feline was accidentally administered a partial tube of K9 Advantix II Large Dog (Imidacloprid-Permethrin-Pyriproxyfen) topically by the owner. This was extra label use of product as it is not labeled for use in cats.

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

Animal's Owner

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 )

3

7. Weight (provide a range if necessary )

3.18

kg

8. Route(s) of exposure

Skin

9. What was the length of exposure?

>8 hrs <= 24 hrs / >8 h <= 24 h

10. Time between exposure and onset of symptoms

<=30 min / <=30 min

11. List all symptoms

System

  • Nervous and Muscular Systems
    • Symptom - Agitation
    • Symptom - Recumbent
    • Symptom - Seizure
    • Symptom - Difficulty getting up
    • Symptom - Muscle twitching
  • Blood
    • Symptom - Hypoglycemia
  • General
    • Symptom - Hypothermia
    • Symptom - Abnormal behaviour
    • Specify - Behavioural disorder NOS (animal ran off outside)
    • Symptom - Death

12. How long did the symptoms last?

>8 hrs <=24 hrs / > 8 h < = 24 h

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

Yes

14. a) Was the animal hospitalized?

Unknown

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 an unspecified date in approximately 2017, a 3 year old, 7 pound, neutered, female, Domestic Shorthair feline, in unknown condition, with no known concomitant medical conditions, was administered 1 tube of Advantage II Small Cat (Imidacloprid-Pyriproxyfen) topically by the owner. On 12-Oct-2017, the feline was accidentally administered a partial tube of K9 Advantix II Large Dog (Imidacloprid-Permethrin-Pyriproxyfen) topically by the owner. This was extra label use of product as it is not labeled for use in cats. The Advantage II Small Cat box contained 1 tube of K9 Advantix II Large Dog within the box. Immediately post application, the cat exhibited agitation and ran off outside (behavioral disorder NOS). On 13-Oct-2017, approximately 12 hours post application, the cat returned home, behavioral disorder NOS resolved, and then exhibited recumbency, seizures and was unable to rise. The cat was examined by a veterinarian, on presentation, the cat continued to exhibit seizures, and hypothermia. The cat was administered 2 unspecified doses of midazolam followed by 1 unspecified dose of Propofol then was administered intravenous fluids; the seizure resolved and the cat began to exhibit twitching. The cat was then bathed with an unspecified hand soap and bloodwork was performed; the blood glucose was 22 (hypoglycemia), the patient was then warmed and the clinical signs continued. Follow up received on 24th Oct 2017: On an unspecified date in approximately 2017, a 3 year old, 7 pound, neutered, female, Domestic Shorthair feline, in unknown condition, with no known concomitant medical conditions, was administered 1 tube of Advantage II Small Cat (Imidacloprid-Pyriproxyfen) topically by the owner. On 12-Oct-2017, the feline was accidentally administered a full tube of K9 Advantix II Large Dog (Imidacloprid-Permethrin-Pyriproxyfen) topically by the owner. This was extra label use of product as it is not labeled for use in cats. The Advantage II Small Cat box contained 1 tube of K9 Advantix II Large Dog within the box. Immediately post application, the cat exhibited agitation and ran off outside (behavioral disorder NOS). On 13-Oct-2017, approximately 12 hours post application, the cat returned home then exhibited recumbency, seizures and was unable to rise. The cat was examined by a veterinarian and exhibited seizures, and hypothermia. The cat was administered 2 unspecified doses of midazolam followed by 1 unspecified dose of propofol then intravenous fluids; the seizure resolved and the cat began to exhibit twitching. The cat was then bathed with an unspecified hand soap and bloodwork was performed; the blood glucose was 22 (hypoglycemia), the patient was then warmed. Approximately 4 hours post onset, the feline died. No necropsy conducted.


To be determined by Registrant

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

Death

19. Provide supplemental information here

Advantage II Small Cat N - Unlikely Agitation and running off are unspecific signs and may have multiple potential other causes in an animal. Serious nervous system disorder such as seizure is not anticipated with topical administration of product. No direct relation in time reported for this product. The use of Advantix containing the active ingredient permethrin which is toxic for cats has to be considered first in that case. Twitching, recumbency, hypothermia and unable to rise are not anticipated after product application, signs are likely a consequence of seizures. Hypoglycemia is likely inter related to seizure. Death is not expected either, as it is inconsistent with pharmaco-toxicological product profile. Cat may have died due to underlying medical condition or application of permethrin containing product. Though time to onset is unknown, overall, a product connection is deemed to be unlikely. K9 Advantix II Large Dog B - Possible Off-label Use (unauthorized species). Reported agitation, seizures and twitching are consistent with permethrin toxicity following direct product use on a cat. Running off might be associated with agitation. Recumbency and unable to rise are likely linked to reported seizures. Hypothermia might be a consequence of therapy. Hypoglycemia is not expected after product exposure, however, might be associated with other reported signs. However, even though permethrin is toxic for cats and may have a fatal outcome, generally cats have a good chance to recover if adequate treatment is applied in time. Considering consistent time to onset and typical signs of permethrin toxicity in cats, a product connection is deemed to be possible.