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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2019-7171

2. Registrant Information.

Registrant Reference Number: USA-BAYERBAH-2019-US0069604 (Report 612305)

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.

27-NOV-19

5. Location of incident.

Country: UNITED STATES

Prov / State: VIRGINIA

6. Date incident was first observed.

08-NOV-19

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. 29777      PMRA Submission No.       EPA Registration No. 11556-141

Product Name: K9advantixII small dog

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

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

Product Name: Seresto small dog

  • Active Ingredient(s)
    • FLUMETHRIN
      • Guarantee/concentration 4.5 %
    • IMIDACLOPRID
      • Guarantee/concentration 10 %

PMRA Registration No.       PMRA Submission No.       EPA Registration No. Unknown

Product Name: MGK Advantage Treatment Shampoo for Dogs and Puppies

  • Active Ingredient(s)
    • N-OCTYL BICYCLOHEPTENE DICARBOXIMIDE
      • Guarantee/concentration .479 %
    • PIPERONYL BUTOXIDE
      • Guarantee/concentration .3 %
    • PYRETHRINS
      • Guarantee/concentration .15 %

7. b) Type of formulation.

Other (specify)

spot-on

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 approximately 01-Jul-2019, an 8 year old, approximately 9 pound, intact, female, Terrier - Silky dog, in unknown condition, with the concomitant medical condition of fleas, that was bathed every 2 weeks with MGK Advantage Treatment Shampoo for Dogs and Puppies (unspecified) (Pyrethrin / Piperonyl Butoxide / N-Octyl Bicycloheptene Dicarboximide) every 2 weeks since Mar 2019 and was administered an unspecified medication orally since an unknown date in 2019, had 1 Seresto Small Dog (Flumethrin-Imidacloprid) collar placed around the neck by the animal owner.

To be determined by Registrant

12. In your opinion, was the product used according to the label instructions?

Unknown

Subform III: Domestic Animal Incident Report

1. Source of Report

Animal's Owner

2. Type of animal affected

Dog / Chien

3. Breed

Terrier - Silky dog

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

8

7. Weight (provide a range if necessary )

4.08

kg

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 - Anorexia
  • Nervous and Muscular Systems
    • Symptom - Difficulty walking
  • General
    • Symptom - Lethargy
  • Renal System
    • Symptom - Urinary incontinence
  • Nervous and Muscular Systems
    • Symptom - Abnormal posture

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

On approximately 01-Sep-2019, the collar was removed for an unknown reason. On 18-Oct-2019, the dog was administered 1 tube of K9 Advantix II Small Dog (Imidacloprid-Permethrin-Pyriproxyfen) topically by the owner. On 08-Nov-2019, the dog exhibited partial anorexia, walking difficulty, lethargy, urinary incontinence, hunched over hanging the head (abnormal posture) and then died. The dog was not evaluated by a veterinarian and no necropsy was performed. No further information is expected.


To be determined by Registrant

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

Death

19. Provide supplemental information here

K9advantix II small dog: Reported partial anorexia and lethargy are unspecific and may have multiple potential other causes in a dog. Though permethrin has the potential to cause mild, transient neurological disorders (e.g. walking difficulty) in particularly susceptible animals, it is not expected after long time to onset. Urinary incontinence, hunched over hanging the head and death are not expected, as it is inconsistent with the pharmaco-toxicological profile of the product. Other causes should be considered. Time to onset is more than 12 hours, therefore an allergic/anaphylactic-type reaction can be ruled out. Moreover, previous applications were well tolerated. Considering long time to onset (20 days) and no necropsy was performed, a product relation is considered unassesssable. Seresto Small dog collar: All observed signs started more than 2 month after collar removal. Reported systemic disorders, walking difficulty and urinary incontinence are reported long time after collar removal, thus not related to product. Later, death is not expected following appropriate topical product application as inconsistent with product's pharmacological profile. Oral exposure to the collar is not expected to cause serious signs either. An overdose of 5 collars around the neck was investigated in adult cats and dogs for an 8 months period and in 10 week old kittens and 7 week old puppies for a 6 months period without causing serious signs. This is supported by the extremely low systemic exposure with imidacloprid and flumethrin, particularly during the first week after application and also thereafter. Moreover, fatal sign was reported long time after collar removal. Considering all aspects, product involvement is unlikely. MGK Advantage Treatment Shampoo for Dogs and Puppies: None of the signs expected following appropriate use of the product. Even in case of oral ingestion would not expect severe sign like death. Product has a wide margin of safety. Moreover, in case of oral ingestion only small amounts are ingested and rather cause mild digestive tract disorders. In this case no oral ingestion witnessed or suspected. Product was well tolerated on a regular basis every two weeks over a period of approximately 7 months. Other products were administered concomitantly. Signs non-specific and rather related to impending death. Time to onset in this case unknown, since previous treatment date unknown. No necropsy performed. Overall, product relation rather unlikely, but due to insufficient information, product relation is considered unclassifiable.