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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2019-4442

2. Registrant Information.

Registrant Reference Number: USA-BAYERBAH-2019-US0036868 (Report 579101)

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.

12-JUL-19

5. Location of incident.

Country: UNITED STATES

Prov / State: UNKNOWN

6. Date incident was first observed.

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

Product Name: Seresto Large Dog

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

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

Product Name: K9 Advantix II pipette size unknown

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

7. b) Type of formulation.

Other (specify)

COLLAR ; Spot-on

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 an unknown date in 2018, a 4 year old, 20 pound, Chihuahua/Terrier (Jack Russell) crossbred canine, of unknown sex and condition, with a history of patellar luxation and frequent urinary tract infections, was administered 1 tube of K9 Advantix II (unspecified) (Imidacloprid-Permethrin-Pyriproxyfen) topically by the owner.On a unknown date post application, the dog had a tick and was switched to an unspecified flea medication. On an unknown date in Jun 2019, the canine was examined by a veterinarian and administered routine vaccinations.On 19 Jun 2019, the canine had one Seresto Large Dog (Flumethrin-Imidacloprid) collar placed around the 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

Animal's Owner

2. Type of animal affected

Dog / Chien

3. Breed

Crossbred [Chihuahua x Terrier (Jack Russell)]

4. Number of animals affected

1

5. Sex

Unknown

6. Age (provide a range if necessary )

4

7. Weight (provide a range if necessary )

9.07

kg

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

  • Renal System
    • Symptom - Other
    • Specify - frequent squatting with lack of urine production
  • Gastrointestinal System
    • Symptom - Anorexia
  • General
    • Symptom - Adipsia
  • Nervous and Muscular Systems
    • Symptom - Ataxia
  • Gastrointestinal System
    • Symptom - Weight loss
  • Renal System
    • Symptom - Anuria
  • Gastrointestinal System
    • Symptom - Drooling
  • Eye
    • Symptom - Nystagmus
  • Nervous and Muscular Systems
    • Symptom - Fasciculations
    • Symptom - Other
    • Specify - Head pressing
    • Symptom - Hallucination
  • General
    • Symptom - Abnormal behaviour
  • Ear
    • Symptom - Hearing loss
  • Eye
    • Symptom - Blindness (permanent)
  • Nervous and Muscular Systems
    • Symptom - Rigidity
  • General
    • Symptom - Death
  • Nervous and Muscular Systems
    • Symptom - Seizure
  • General
    • Symptom - Other
    • Specify - Meningitis
  • Nervous and Muscular Systems
    • Symptom - Muscle cramps
    • Symptom - Abnormal posture
    • Specify - ventral neck flexion
    • Symptom - Paralysis
    • Specify - left facial nerve paralysis

12. How long did the symptoms last?

Unknown / Inconnu

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 02 Jul 2019, the canine exhibited unspecified urinary signs, including frequent squatting with lack of urine production. In addition, the dog was not eating or drinking, was ataxic in the back end and exhibited weight loss. The canine was examined by a veterinarian and weighed 18.2 pounds. A urinalysis was performed and was within normal limits. The dog was started on amoxicillin/ clavulanic acid. On 03 Jul 2019, the collar was removed and the dog was bathed with dish soap. On 05-Jul-2019, the canine weighed 15 pounds. On 08 Jul 2019, the dog was examined by a veterinarian. The clinical signs continued. A complete blood count was performed and was within normal limits. Radiographs were performed and the results are unknown. On 10 Jul 2019, the dog was examined by a veterinarian and exhibited ventral neck flexion, but no other clinical signs. No diagnostics were performed. Approximately 8 hours later, the dog exhibited meningitis, drooping, left facial nerve paralysis, seizure, drooling, nystagmus, muscle contractions of the face, head pressing, hallucinating, abnormal behavior, loss of hearing, loss of sight, rigid jaw. The dog died and no necropsy was performed.


To be determined by Registrant

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

Death

19. Provide supplemental information here

Seresto: N - Unlikely A tick was reported prior to collar application, hence not related to the product. Renal disorders are not expected following appropriate topical product application. However animal had concomitant history of urinary tract infection, which may have contributed to the signs. Further, ataxia is not typically seen with appropriate topical product administration. Not eating and drinking is likely associated with other signs. Weight loss is not expected either. The collar was removed, and despite this, dog's condition deteriorated. Further reported serious neurological, sensory and behavioural signs are not expected following appropriate topical product application as inconsistent with product's pharmacological profile. Overdose of 5 collars around the neck of adult dogs for an 8 months period and in 7 week old puppies for a 6 months period did not cause 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. Even with oral product exposure, seizures are not seen. Signs are likely associated with reported meningitis, which typically has an infectious cause. Moreover, signs reported after collar removal. Death is likely the result of the meningitis. Time to onset is long. Overall, a product relation is unlikely. Advantix: N - Unlikely Dog was treated with the product in 2018. A single tick was reported in 2018, unknown how long after product application. The product's repellent effect against ticks is not 100%. Attachment of individual ticks is possible when infestation pressure is high. This is mentioned in the product information. Moreover, without further information, it is possible that the tick was found after the product's efficacy period of 4 weeks. Later reported signs were reported long time after product use (at least 7 months). Signs are not expected following product use, as it is inconsistent with the pharmaco-toxicological profile of the product. In fact, meningitis was diagnosed, which commonly has an infectious cause. Considering overall aspects, a product connection is considered unlikely.