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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2011-3847

2. Registrant Information.

Registrant Reference Number: 1-25099897

Registrant Name (Full Legal Name no abbreviations): WELLMARK INTERNATIONAL

Address: 100 STONE ROAD WEST, SUITE 111

City: GUELPH

Prov / State: ON

Country: CANADA

Postal Code: N1G 5L3

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

Domestic Animal

4. Date registrant was first informed of the incident.

03-JAN-11

5. Location of incident.

Country: UNITED STATES

Prov / State: FLORIDA

6. Date incident was first observed.

Unknown

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. 2724-504-2596

Product Name: Ultraguard Plus drops for cats

  • 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.

.061

Units: oz (fl) / oz (liquide)

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).

Owner applied product to cat on January 1st, 2011.

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

Medical Professional

2. Type of animal affected

Cat / Chat

3. Breed

unknown

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

14

7. Weight (provide a range if necessary )

7.10

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

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

10. Time between exposure and onset of symptoms

>30 min <=2 hrs / >30 min <=2 h

11. List all symptoms

System

  • General
    • Symptom - Lethargy
  • Gastrointestinal System
    • Symptom - Anorexia
  • Cardiovascular System
    • Symptom - Tachycardia
  • General
    • Symptom - Dehydration
  • Renal System
    • Symptom - Creatinine increased
    • Specify - Creatinine increase
  • General
    • Symptom -
    • Specify - hypothyroid
  • Liver
    • Symptom - Elevated liver enzymes
    • Specify - ALT and ALP elevated
  • Blood
    • Symptom - Anemia
  • Liver
    • Symptom - Other
    • Specify - Heme/Hepatic Magnesium slightly elevated

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?

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

DVM received call from owner on January 3rd 2011. Owner stated product was applied to cat on January 1st 2011. Owner stated within hours cat became symptomatic. DVM instructed owner to bath the cat and bring him in. The owners had wiped the cat down with a sponge before bringing cat to DVM on January 3rd. DVM stated cat had been anorexic for 24-48 hours and had lost 1 pound since she last saw the cat 3 years ago. They bathed the cat in Dawn and gave it SQ fluids. They pulled blood but not urine (no urine in bladder). The cat was not kept in hospital but was sent home with Frontline. DVM called the owners on Tuesday January 4th, 2011 when the blood work came back. Tests concluded cat had severe anemia. Hgb was 4.8, HCT was 16.2%, and RCB's were low at 3.33. She suspects anemia of this severity without trauma was likely due to heavy flea infestation at home even though there were not alot of fleas on the cat on presentation. ALT was elevated (121) as was ALP (179): BUN (113) and creatinine (75) were also elevated. She thinks there was some chronic RF with dehydration exaggerating the level of azotemia. Calcium was low but when adjusted for albumin was normal. Mg was elevated slightly and thyroid T4 was low (0.2; 0.8-4). She told the owners the cat needed a transfusion and they should go to a 24 hr critical care/internal medicine facility. The owners indicated the cat seemed stronger - was eating drinking and urinating. They did not want to spend more money. Cat later died on Tuesday January 4th or Wednesday January 5th, 2011.


To be determined by Registrant

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

Death

19. Provide supplemental information here

DVM thinks the application of the Hartz product was inappropriate and was likely too much for the cat in his debilitated condition. The owners had last brought in the cat 3 years ago for flea issues.