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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2015-0823

2. Registrant Information.

Registrant Reference Number: 140143407

Registrant Name (Full Legal Name no abbreviations): Wellmark International

Address: 100 Stone Road West, Suite 111

City: Guelph

Prov / State: Ontario

Country: Canada

Postal Code: N1G5L3

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

Domestic Animal

4. Date registrant was first informed of the incident.

11-NOV-14

5. Location of incident.

Country: UNITED STATES

Prov / State: OHIO

6. Date incident was first observed.

09-NOV-14

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. 2724-803-270

Product Name: Adams Flea and Tick Spray for Cats

  • Active Ingredient(s)
    • (S)-METHOPRENE
      • Guarantee/concentration .1 %
    • ETOFENPROX
      • Guarantee/concentration .25 %
    • PIPERONYL BUTOXIDE
      • Guarantee/concentration .75 %

7. b) Type of formulation.

Liquid

Application Information

8. Product was applied?

Yes

9. Application Rate.

Unknown

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 November 8, 2014 the owner bathed the cat with cat flea shampoo and found a few fleas on her. Later that night, the owner sprayed the cat with the Adams spray.

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

Cat / Chat

3. Breed

Domestic Longhair

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

12.0

7. Weight (provide a range if necessary )

8.0

lbs

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

  • Nervous and Muscular Systems
    • Symptom - Coma
  • Gastrointestinal System
    • Symptom - Drooling
  • General
    • Symptom - Death

12. How long did the symptoms last?

Persisted until death

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 November 9, 2014 the owners found the cat in a coma (they attempted to wake her, her eyes were open, she was breathing, but unresponsive and limp) and was hypersalivating (foaming). The cat was in this condition until she died that night. On November 10, the owner took the cat's body to the veterinary clinic where they planned to cremate her. On November 11, 2014 the owner contacted the Animal Product Safety Service (APSS). The APSS veterinarian stated if ingested, gastrointestinal (GI) upset and/or a taste reaction may occur. The APSS veterinarian further stated central nervous system (CNS) depression is possible if this is alcohol based and the pet was saturated. The APSS veterinarian finally stated that the cat's signs are more severe than would be expected with label use of the product. The APSS veterinarian stated with the cat flea shampoo that systemic effects are unlikely from insecticidal shampoos and in some cats, the stress of bathing can cause decomposition of occult diseases such as heart disease. The APSS veterinarian recommended obtaining additional information (call back with flea shampoo info and lot numbers), a necropsy (owner is going to call regular veterinarian to find out if the body is still available), and calling back with questions.


To be determined by Registrant

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

Death

19. Provide supplemental information here

On November 11, 2014 the owner called the APSS to state that the veterinary clinic still had the cat's body. The APSS veterinarian stated she would get permission for the necropsy (as the body was at room temperature for 9 hours prior to taking her to the clinic), the diagnostic team stated the necropsy was fine. Shortly after, the APSS veterinarian called the veterinary clinic to discuss submission of the body for necropsy. On November 14, 2014 the veterinary staff contacted the APSS veterinarian to discuss issues she was running into while submitting the body. On November 17, 2014 an APSS technician called the veterinary staff to discuss submission for the necropsy. On November 19, 2014 the interim necropsy results were received. The interim results revealed a morphologic diagnosis of enteric nematodiasis and stated the cause of the animal's demise cannot be concluded at this time. The interim results also stated the histopathology examination is in progress, results will follow shortly, and specimens are reserved for ancillary testing if warranted by histopathology findings. On December 1, 2014 the final necropsy results were received. The final results revealed a microscopic diagnosis of chronic interstitial nephritis, hepatopathy with hepatocellular vacuoles and pigments, and pulmonary edema. The histopathology suggests that the cause of the animal's demise is possibly, in part, contributed by underlying kidney and liver diseases. Finding in the lungs is likely a terminal change. An additional histochemical stains specific for iron/hemosiderin (Prussian blue) is conducted on slide 6. The pigments found in hepatocytes are negative for Prussian blue, suggestive of lipofuscin. The final microscopic diagnosis was hepatopathy with hepatocellular vacuoles and lipofuscinosis. On December 2, 2014 the APSS veterinarian called the attending veterinary clinic to make sure they had received a copy of the necropsy result. The attending veterinary staff requested the APSS veterinarian call the owner to discuss. On December 2, 2014 the owner returned the APSS's call to discuss the results. The APSS veterinarian discussed the results with the owner that there was no specific indication as to why the pet developed signs following the application of the product. The APSS veterinarian also stated pathology finds are likely consistent with age and unlikely to have contributed to adverse reaction to application of the agent. The APSS veterinarian recommended contacting the manufacturer for additional questions or concerns.