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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2008-4760

2. Registrant Information.

Registrant Reference Number: 334135

Registrant Name (Full Legal Name no abbreviations): Sergeant's Pet Care Products, Inc. /DBA PetLogic, LLC

Address: 2625 South 158th Plaza

City: Omaha

Prov / State: NE

Country: United States

Postal Code: 68130

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

Domestic Animal

4. Date registrant was first informed of the incident.

18-JUN-08

5. Location of incident.

Country: UNITED STATES

Prov / State: INDIANA

6. Date incident was first observed.

18-JUN-08

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. 69332-3-2517

Product Name: Sergeant's Gold Flea and Tick Squeeze-On for Cats and Kittens

  • Active Ingredient(s)
    • ETOFENPROX
      • Guarantee/concentration 55 %
    • PYRIPROXYFEN
      • Guarantee/concentration 2.2 %

7. b) Type of formulation.

Liquid

Application Information

8. Product was applied?

Yes

9. Application Rate.

.7

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).

Product applied to cat. Details unknown regarding application.

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 Shorthair

4. Number of animals affected

1

5. Sex

Unknown

6. Age (provide a range if necessary )

3

7. Weight (provide a range if necessary )

10

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

>2 hrs <=8 hrs / >2 h <=8 h

10. Time between exposure and onset of symptoms

>8 hrs <=24 hrs / > 8 h < = 24 h

11. List all symptoms

System

  • Nervous and Muscular Systems
    • Symptom - Muscle tremors
    • Symptom - Seizure
    • Symptom - Rigidity
  • General
    • Symptom - Fever
  • Gastrointestinal System
    • Symptom - Bloody vomit
    • Symptom - Other
    • Specify - Mucous per rectum

12. How long did the symptoms last?

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

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?

8

Hour(s) / Heure(s)

15. Outcome of the incident

Euthanised / Euthanasie

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

Caller states that he applied the product to both of his cats and they started to tremor and vomit blood. Caller brought both cats to the DVM and was told there was nothing they could do to help his cats. DMV states both cats are experiencing muscle rigidness, fever, hematemesis/UGI Bleed, mucous per rectum. DMV states that the owner told them the symptoms started about 3 hours after application. Administered 1 cc diazpam iv, stopped seisure but not tremors, administered 2 cc robaxin iv, minimal effect, 1/2 cc phenobarbital iv, this reduced tremors greatly, 6:25 repeated pheno 1/2 cc iv again 7 pm; at 7:25 pm applied warm compress and tremors worse again so gave 1./2 cc pheno iv and 1/2 cc pheno im, gave 1 cc propofol to sedate. Called owners at 9 pm recommend transfer. Owners decided to euthanize.


To be determined by Registrant

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

Death

19. Provide supplemental information here

DVM stated would not expect to see these SXS with labeled use of the product. Recommend exploring other etiologies for the SXS.

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

Unknown

6. Age (provide a range if necessary )

3

7. Weight (provide a range if necessary )

10

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

>2 hrs <=8 hrs / >2 h <=8 h

10. Time between exposure and onset of symptoms

>2 hrs <=8 hrs / > 2 h < = 8 h

11. List all symptoms

System

  • Gastrointestinal System
    • Symptom - Bloody vomit
  • General
    • Symptom - Fever
  • Gastrointestinal System
    • Symptom - Other
    • Specify - Mucous per rectum
  • Nervous and Muscular Systems
    • Symptom - Muscle tremors
    • Symptom - Rigidity
    • Symptom - Seizure

12. How long did the symptoms last?

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

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?

8

Hour(s) / Heure(s)

15. Outcome of the incident

Euthanised / Euthanasie

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

Caller states that he applied the product to both of his cats and they started to tremor and vomit blood. Caller brought both cats to the DVM and was told there was nothing they could do to help his cats. DMV states both cats are experiencing muscle rigidness, fever, hematemesis/UGI Bleed, mucous per rectum. DMV states that the owner told them the symptoms started about 3 hours after application. Administered 1 cc diazpam iv, stopped seisure but not tremors, administered 2 cc robaxin iv, minimal effect, 1/2 cc phenobarbital iv, this reduced tremors greatly, 6:25 repeated pheno 1/2 cc iv again 7 pm; at 7:25 pm applied warm compress and tremors worse again so gave 1./2 cc pheno iv and 1/2 cc pheno im, gave 1 cc propofol to sedate. Called owners at 9 pm recommend transfer. Owners decided to euthanize.


To be determined by Registrant

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

Death

19. Provide supplemental information here

DVM stated would not expect to see these SXS with labeled use of the product. Recommend exploring other etiologies for the SXS.