Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2016-0722

2. Registrant Information.

Registrant Reference Number: ProPharma case: 1-42749242

Registrant Name (Full Legal Name no abbreviations): FMC Corporation

Address: 1735 Market Street

City: Philadelphia

Prov / State: Pennsylvania

Country: USA

Postal Code: 19103

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

Human

Domestic Animal

4. Date registrant was first informed of the incident.

17-DEC-15

5. Location of incident.

Country: CANADA

Prov / State: ONTARIO

6. Date incident was first observed.

17-DEC-15

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)

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PMRA Registration No. 24175      PMRA Submission No.       EPA Registration No. Unknown

Product Name: Dragnet

• Active Ingredient(s)
  • PERMETHRIN

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7. b) Type of formulation.

Application Information

8. Product was applied?

Yes

9. Application Rate.

Unknown

10. Site pesticide was applied to (select all that apply).

Site: Res. - In Home / Rés. - à l'int. maison

11. Provide any additional information regarding application (how it was applied, amount applied, the size of the area treated etc).

1-42749242 - The PCO applied the product directly on food and dishes in the apartment and while the reporter's cats were in the application site.

To be determined by Registrant

12. In your opinion, was the product used according to the label instructions?

No

Subform II: Human Incident Report (A separate form for each person affected)

1. Source of Report.

Data Subject

2. Demographic information of data subject

Sex: Female

Age: >19 <=64 yrs / >19 <=64 ans

3. List all symptoms, using the selections below.

System

• Gastrointestinal System
  • Symptom - Irritated throat

• Eye
  • Symptom - Irritated eye

4. How long did the symptoms last?

Unknown / Inconnu

5. Was medical treatment provided? Provide details in question 13.

Unknown

6. a) Was the person hospitalized?

Unknown

6. b) For how long?

7. Exposure scenario

Non-occupational

8. How did exposure occur? (Select all that apply)

Contact with treated area

What was the activity? Daily living

9. If the exposure occured during application or re-entry, what protective clothing was worn? (select all that apply)

Unknown

10. Route(s) of exposure.

Respiratory

11. What was the length of exposure?

Unknown / Inconnu

12. Time between exposure and onset of symptoms.

Unknown / Inconnu

13. Provide any additional details about the incident (eg. description of the frequency and severity of the symptoms, type of medical treatment, results from medical tests, outcome of the incident, amount of pesticide exposed to, etc.)

1-42479146 - The reporter indicated that she, her husband and her two cats were exposed to an insecticide containing the active ingredient permethrin. The reporter stated that a PCO applied the product inside the apartment on the day of initial contact while her husband was sleeping in a bedroom in the apartment and while her cats were wondering around in the treated rooms. The reporters husband woke-up while the PCO was in the apartment and when the husband opened the bedroom door the PCO got frightened and ran away. Per the reporter the PCO had sprayed all over the apartment including in the kitchen on their food and dishes. The reporter states that both of her cats; a Maine coon (Subform III #1) and a Norwegian Forest cat (Subform III #2) became lethargic, developed tremors and had breathing difficulties after the exposure. The cats were brought to the veterinarian where they were bathed and treated with methocarbamol and at the time of the call they were doing a little better. The reporter (Subform II #1) and her husband (Subform II #2) had irritated eyes and throat and initially her husband had difficulty breathing but that was better at the time of the call. Her husband also vomited and he developed hives which were still an issue at the time of the call. On follow-up call, ten days later, the reporter indicated that her throat was still sore and she was worried her cats also had sore throats because they were not drinking water like they used to. The reporter also indicated that the cats had been snoring sometimes since the exposure. The reporters husband still had hives that intermittently flared up. He was taking Benadryl, which helped, but the hives keep coming back. No additional information is available.

To be determined by Registrant

14. Severity classification.

Minor

15. Provide supplemental information here.

Subform II: Human Incident Report (A separate form for each person affected)

1. Source of Report.

Other

2. Demographic information of data subject

Sex: Male

Age: >19 <=64 yrs / >19 <=64 ans

3. List all symptoms, using the selections below.

System

• Gastrointestinal System
  • Symptom - Irritated throat

• Eye
  • Symptom - Irritated eye

• Gastrointestinal System
  • Symptom - Vomiting

• Respiratory System
  • Symptom - Difficulty Breathing

• Skin
  • Symptom - Hives

4. How long did the symptoms last?

Unknown / Inconnu

5. Was medical treatment provided? Provide details in question 13.

Unknown

6. a) Was the person hospitalized?

Unknown

6. b) For how long?

7. Exposure scenario

Non-occupational

8. How did exposure occur? (Select all that apply)

Contact with treated area

What was the activity? Daily living; including sleeping near application site while product was applied

9. If the exposure occured during application or re-entry, what protective clothing was worn? (select all that apply)

Unknown

10. Route(s) of exposure.

Unknown

11. What was the length of exposure?

Unknown / Inconnu

12. Time between exposure and onset of symptoms.

Unknown / Inconnu

13. Provide any additional details about the incident (eg. description of the frequency and severity of the symptoms, type of medical treatment, results from medical tests, outcome of the incident, amount of pesticide exposed to, etc.)

1-42479146 - The reporter indicated that she, her husband and her two cats were exposed to an insecticide containing the active ingredient permethrin. The reporter stated that a PCO applied the product inside the apartment on the day of initial contact while her husband was sleeping in a bedroom in the apartment and while her cats were wondering around in the treated rooms. The reporters husband woke-up while the PCO was in the apartment and when the husband opened the bedroom door the PCO got frightened and ran away. Per the reporter the PCO had sprayed all over the apartment including in the kitchen on their food and dishes. The reporter states that both of her cats; a Maine coon (Subform III #1) and a Norwegian Forest cat (Subform III #2) became lethargic, developed tremors and had breathing difficulties after the exposure. The cats were brought to the veterinarian where they were bathed and treated with methocarbamol and at the time of the call they were doing a little better. The reporter (Subform II #1) and her husband (Subform II #2) had irritated eyes and throat and initially her husband had difficulty breathing but that was better at the time of the call. Her husband also vomited and he developed hives which were still an issue at the time of the call. On follow-up call, ten days later, the reporter indicated that her throat was still sore and she was worried her cats also had sore throats because they were not drinking water like they used to. The reporter also indicated that the cats had been snoring sometimes since the exposure. The reporters husband still had hives that intermittently flared up. He was taking Benadryl, which helped, but the hives keep coming back. No additional information is available.

To be determined by Registrant

14. Severity classification.

Moderate

15. Provide supplemental information here.

Subform III: Domestic Animal Incident Report

1. Source of Report

Animal's Owner

2. Type of animal affected

Cat / Chat

3. Breed

Maine Coon

4. Number of animals affected

1

5. Sex

Unknown

6. Age (provide a range if necessary )

Unknown

7. Weight (provide a range if necessary )

Unknown

8. Route(s) of exposure

Unknown

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

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

11. List all symptoms

System

• General
  • Symptom - Lethargy

• Nervous and Muscular Systems
  • Symptom - Trembling

• Respiratory System
  • Symptom - Respiratory irritation

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?

Unknown

14. b) How long was the animal hospitalized?

15. Outcome of the incident

Unknown/Inconnu

16. How was the animal exposed?

Contact treat.area/Contact surf. traitée

17. Provide any additional details about the incident

(eg. description of the frequency and severity of the symptoms

1-42479146 - The reporter indicated that she, her husband and her two cats were exposed to an insecticide containing the active ingredient permethrin. The reporter stated that a PCO applied the product inside the apartment on the day of initial contact while her husband was sleeping in a bedroom in the apartment and while her cats were wondering around in the treated rooms. The reporters husband woke-up while the PCO was in the apartment and when the husband opened the bedroom door the PCO got frightened and ran away. Per the reporter the PCO had sprayed all over the apartment including in the kitchen on their food and dishes. The reporter states that both of her cats; a Maine coon (Subform III #1) and a Norwegian Forest cat (Subform III #2) became lethargic, developed tremors and had breathing difficulties after the exposure. The cats were brought to the veterinarian where they were bathed and treated with methocarbamol and at the time of the call they were doing a little better. The reporter (Subform II #1) and her husband (Subform II #2) had irritated eyes and throat and initially her husband had difficulty breathing but that was better at the time of the call. Her husband also vomited and he developed hives which were still an issue at the time of the call. On follow-up call, ten days later, the reporter indicated that her throat was still sore and she was worried her cats also had sore throats because they were not drinking water like they used to. The reporter also indicated that the cats had been snoring sometimes since the exposure. The reporters husband still had hives that intermittently flared up. He was taking Benadryl, which helped, but the hives keep coming back. No additional information is available.

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To be determined by Registrant

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

Moderate

19. Provide supplemental information here

Subform III: Domestic Animal Incident Report

1. Source of Report

Animal's Owner

2. Type of animal affected

Cat / Chat

3. Breed

Norwegian Forest Cat

4. Number of animals affected

1

5. Sex

Unknown

6. Age (provide a range if necessary )

Unknown

7. Weight (provide a range if necessary )

Unknown

8. Route(s) of exposure

Unknown

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

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

11. List all symptoms

System

• General
  • Symptom - Lethargy

• Nervous and Muscular Systems
  • Symptom - Trembling

• Respiratory System
  • Symptom - Respiratory irritation

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?

Unknown

14. b) How long was the animal hospitalized?

15. Outcome of the incident

Unknown/Inconnu

16. How was the animal exposed?

Contact treat.area/Contact surf. traitée

17. Provide any additional details about the incident

(eg. description of the frequency and severity of the symptoms

1-42479146 - The reporter indicated that she, her husband and her two cats were exposed to an insecticide containing the active ingredient permethrin. The reporter stated that a PCO applied the product inside the apartment on the day of initial contact while her husband was sleeping in a bedroom in the apartment and while her cats were wondering around in the treated rooms. The reporters husband woke-up while the PCO was in the apartment and when the husband opened the bedroom door the PCO got frightened and ran away. Per the reporter the PCO had sprayed all over the apartment including in the kitchen on their food and dishes. The reporter states that both of her cats; a Maine coon (Subform III #1) and a Norwegian Forest cat (Subform III #2) became lethargic, developed tremors and had breathing difficulties after the exposure. The cats were brought to the veterinarian where they were bathed and treated with methocarbamol and at the time of the call they were doing a little better. The reporter (Subform II #1) and her husband (Subform II #2) had irritated eyes and throat and initially her husband had difficulty breathing but that was better at the time of the call. Her husband also vomited and he developed hives which were still an issue at the time of the call. On follow-up call, ten days later, the reporter indicated that her throat was still sore and she was worried her cats also had sore throats because they were not drinking water like they used to. The reporter also indicated that the cats had been snoring sometimes since the exposure. The reporters husband still had hives that intermittently flared up. He was taking Benadryl, which helped, but the hives keep coming back. No additional information is available.

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To be determined by Registrant

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

Moderate

19. Provide supplemental information here