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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2016-5177

2. Registrant Information.

Registrant Reference Number: 160101089

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-JUL-16

5. Location of incident.

Country: UNITED STATES

Prov / State: KANSAS

6. Date incident was first observed.

17-JUN-16

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. 2724-813-270

Product Name: Adams Flea and Tick Spot On for Cats Over 2.5 Lbs But Under 5 Lbs

  • Active Ingredient(s)
    • (S)-METHOPRENE
      • Guarantee/concentration 3.6 %
    • ETOFENPROX
      • Guarantee/concentration 40 %

7. b) Type of formulation.

Liquid

Application Information

8. Product was applied?

Yes

9. Application Rate.

1

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 June 15, 2016 the owner applied the product onto the cat for prevention.

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

Cat / Chat

3. Breed

Domestic Shorthair

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

6.0

7. Weight (provide a range if necessary )

10.88

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

>24 hrs <=3 days / >24 h <=3 jours

11. List all symptoms

System

  • Skin
    • Symptom - Hair loss
    • Specify - at application site
    • Symptom - Other
    • Specify - Ulceration
  • Gastrointestinal System
    • Symptom - Loss of appetite
  • General
    • Symptom - Other
    • Specify - Behavior Change
    • Symptom - Lethargy
  • Skin
    • Symptom - Jaundice
  • Blood
    • Symptom - Anemia
  • Gastrointestinal System
    • Symptom - Bloody stool
  • Respiratory System
    • Symptom - Laboured breathing
  • Blood
    • Symptom - Hypoglycemia
    • Symptom - Hypoproteinemia
    • Symptom - Hypoalbuminemia
    • Symptom - Other
    • Specify - Elevated ALT
    • Symptom - Hyperbilirubinemia
    • Symptom - Thrombocytopenia
    • Symptom - Other
    • Specify - Neutropenia
    • Symptom - Other
    • Specify - Lymphopenia
  • General
    • Symptom - Death

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?

Yes

14. b) How long was the animal hospitalized?

Unknown

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 June 17, 2016 the cat developed alopecia (at application site). On June 20, 2016 the application site developed skin ulceration. On July 4, 2016 the cat developed inappetence (wouldn't eat her food, but would eat the other cat's food), a behavior change (found her with her head laying on the water bowl), and lethargy. On July 6, 2016 the cat developed icterus and anemia. Later that day, the owner took the cat to the emergency clinic, where a chemistry profile was completed. The cat was diagnosed with hypoglycemia, hypoproteinemia, hypoalbuminemia, elevated alanine aminotransferase (ALT), hyperbilirubinemia, thrombocytopenia, neutropenia, and lymphopenia. The cat's hematocrit on June 6, 2016 was 8.2 percent volume to volume (% v/v), serum glucose was 22.0 milligrams per deciliter (mg/dL), serum albumin was 2.1 grams per deciliter (g/dL), serum bilirubin total was 4.1 mg/dL, serum total protein was 5.2 g/dL, white blood cell count was 2.88 (this is very low normal), segmented neutrophils were 1.36, lymphocytes were 1.09, blood platelets were 78,000.0 count, and partial thromboplastin time was 156.0 seconds (s). The attending emergency veterinarian gave the cat butorphanol tartrate (0.1 mL intravenously (IV)), hospitalized the cat and began oxygen, and gave dextrose (2 mL injection (inj) (50% IV diluted 1:2 with saline)). On July 7, 2016 the emergency attending veterinarian started the cat on fluid therapy, a blood transfusion, and gave enrofloxacin (25 mg inj IV diluted with 1:1 saline). A few hours later the cat was transferred to a regular veterinarian. Later that morning, the cat was transferred back to the emergency clinic. The cat received fluid therapy, symptomatic and supportive care, and was given prednisolone. The cat's prothrombin time was 16.0 s. On July 8, 2016 the emergency veterinarian gave more prednisolone (10 mg by mouth (PO)) and the cat's hematocrit measured at 19.0 % v/v (post transfusion) so the anemia had become less severe. On July 11, 2016 the owner contacted the Animal Product Safety Service (APSS) to discuss the case as the cat died on July 8, 2016. The APSS veterinarian stated etofenprox is in the pyrethroid family, and is safe to use on cats and dogs as a topical agent to treat fleas. The APSS veterinarian also stated it does not result in tremors or seizure activity that can be seen from other pyrethroids, since it is structurally different. The APSS veterinarian further stated dermal exposures may cause mild dermal irritation, redness, pruritus, and paresthesia at the application site within the first 24-48 hours and secondary alopecia may occur from scratching or biting at the treated areas. The APSS veterinarian additionally stated oral exposures often result in hypersalivation, nausea, and vomiting because of the taste and some animals will hypersalivate just from the odor of the product. The APSS veterinarian furthermore stated s-methoprene is an insect growth regulator (IGR). The APSS veterinarian finally stated primary concerns from topical administration are for mild dermal irritation and redness, usually from the carriers; if ingested there could be hypersalivation and nausea. The owner stated the attending veterinarian felt the cat's red blood cells (RBCs) were being destroyed. The APSS veterinarian advised the owner that the product does not directly injury the RBCs nor is it a likely culprit to elicit an allergic response. The APSS veterinarian stated she suspected it is an unfortunate coincidence and since the cat's body had been buried a recommended necropsy is no longer an option. The APSS veterinarian recommended calling back with questions after the medical record was faxed to the APSS to review.


To be determined by Registrant

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

Death

19. Provide supplemental information here

The APSS veterinarian stated the alopecia and local dermatitis is likely from the product, but the anemia, icterus, and death is not. On July 12, 2016 the APSS received the faxed medical record from the emergency clinic. On July 15, 2016 the owner called the APSS to inquire whether the APSS had received the medical records. The APSS veteriarnian confirmed that the records were received and that per the previous APSS veterinarian's assessment that the most likely cause was a sepsis. On July 18, 2016 the owner called the APSS back to state that the cat developed sepsis because of the dermatitis caused by the spot on. The APSS assistant stated she would update the APSS veterinarian. The owner declined further consult with the APSS.