MAUDE Adverse Event Report: PFIZER CONSUMER HEALTH CARE THERMACARE LOWER BACK & HIP; DISPOSABLE PACK, HOT

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Tissue Damage (2104); Discharge (2225)

Event Date 02/20/2016

Event Type  Injury  

Event Description

Walnut-sized, heavily exuding wound on the abdomen, where the patch-closure was [wound].Walnut-sized, heavily exuding wound on the abdomen, where the patch-closure was [wound drainage].Administered it for about 10 hours [intentional device misuse].Case description: this is a spontaneous report from a contactable consumer or other non hcp.A female patient of an unspecified age and ethnicity started to use thermacare heatwrap (thermacare lower back & hip) from an unspecified date for an unspecified indication.The patient's medical history and concomitant medications were not reported.On (b)(6) 2016, the patient reported buying the product in a pharmacy and administered it for about 10 hours.She stated "already on (b)(6) 2016, an approximately walnut-sized wound on the abdomen developed, where the patch closure was.One day later, on (b)(6) 2016, i visited my general practitioner.After a thorough examination, he prescribed me compresses and a wound and healing ointment.Because the wound was heavily exuding, i had to bandage it several times a day.On (b)(6) 2016, i visited a dermatologist.She prescribed a skin antibiotic, fusicutan ointment.On (b)(6) 2016, i had another appointment with my general practitioner for an examination.The therapy is still not complete.As a precaution, i have also informed the regulatory authority (b)(6) about it".Action taken with the suspect product was unknown.Therapeutic measures taken included compresses, unspecified wound and healing ointment, bandages and skin antibiotic fusicutan ointment.Clinical outcome of the events was not resolved.Additional information has been requested and will be provided as it becomes available.Company clinical evaluation comment: based on the information provided, the events of "walnut-sized, heavily exuding wound on the abdomen, where the patch-closure was" as described in this case are considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure, assessed as associated with the use of the device.The device misuse is assessed as non-serious and assessed as associated with the use of the device.This case meets initial 10-day eu and 30-day fda reportability.Case comment: based on the information provided, the events of "walnut-sized, heavily exuding wound on the abdomen, where the patch-closure was" as described in this case are considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure, assessed as associated with the use of the device.The device misuse is assessed as non-serious and assessed as associated with the use of the device.This case meets initial 10-day eu and 30-day fda reportability.

Event Description

Case description: this is a spontaneous report from a contactable consumer and her health insurance company.A (b)(6) female patient of an unspecified ethnicity started to use thermacare heatwrap (thermacare lower back & hip) from an unspecified date for an unspecified indication.The patient's medical history and concomitant medications were not reported.On (b)(6) 2016, the patient reported buying the product in a pharmacy and administered it for about 10 hours.On (b)(6) 2016, an approximately walnut-sized wound on the abdomen developed, where the patch closure was.Upon follow up, the patient's health insurance company reported "the patient experienced an injury to health on (b)(6) 2016.The patient bought a thermacare heatwrap back in the pharmacy.After wearing this heatwrap a walnut size burn appeared on the skin." on (b)(6) 2016, she visited her general practitioner.After a thorough examination, he prescribed compresses and a wound and healing ointment.Because the wound was heavily exuding, she had to bandage it several times a day.On (b)(6) 2016, she visited a dermatologist.She prescribed a skin antibiotic, fusicutan ointment.On (b)(6) 2016, she had another appointment with her general practitioner for an examination.The therapy was still not complete.As a precaution, she had also informed the regulatory authority (b)(4) about it.Action taken with the suspect product was unknown.Therapeutic measures taken included compresses, unspecified wound and healing ointment, bandages and skin antibiotic fusicutan ointment.Clinical outcome of the events was not resolved.Additional information has been requested and will be provided as it becomes available.Follow up (08apr2016): new information received from a health insurance company of the patient included patient's date of birth and reaction data (onset date of event and additional event "after wearing this heatwrap a walnut size burn appeared on the skin").Company clinical evaluation comment: based on the information provided, the events of "walnut-sized burn, heavily exuding wound on the abdomen, where the patch-closure was" as described in this case are considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure, assessed as associated with the use of the device.The device misuse is assessed as non-serious and assessed as associated with the use of the device.This case meets follow-up 10-day eu and 30-day fda reportability.Follow-up (15apr2016): this is a follow-up report to notify that case (b)(4) and case (b)(4) are duplicates.All subsequent follow-up information will be reported under (b)(4).This case (b)(4) is being deleted from the database.

Event Description

Walnut size burn on the skin [thermal burn].Walnut-sized, heavily exuding wound on the abdomen, where the patch-closure was [wound].Walnut-sized, heavily exuding wound on the abdomen, where the patch-closure was [wound drainage].Administered it for about 10 hours [intentional device misuse].Case description: this is a spontaneous report from a contactable consumer and her health insurance company.A (b)(6) female patient of an unspecified ethnicity started to use thermacare heatwrap (thermacare lower back & hip) from an unspecified date for an unspecified indication.The patient's medical history and concomitant medications were not reported.On (b)(6) 2016, the patient reported buying the product in a pharmacy and administered it for about 10 hours.On (b)(6) 2016, an approximately walnut-sized wound on the abdomen developed, where the patch closure was.Upon follow up, the patient's health insurance company reported "the patient experienced an injury to health on (b)(6) 2016.The patient bought a thermacare heatwrap back in the pharmacy.After wearing this heatwrap a walnut size burn appeared on the skin." on (b)(6) 2016, she visited her general practitioner.After a thorough examination, he prescribed compresses and a wound and healing ointment.Because the wound was heavily exuding, she had to bandage it several times a day.On (b)(6) 2016, she visited a dermatologist.She prescribed a skin antibiotic, fusicutan ointment.On (b)(6) 2016, she had another appointment with her general practitioner for an examination.The therapy was still not complete.As a precaution, she had also informed the regulatory authority bfarm about it.Action taken with the suspect product was unknown.Therapeutic measures taken included compresses, unspecified wound and healing ointment, bandages and skin antibiotic fusicutan ointment.Clinical outcome of the events was not resolved.Additional information has been requested and will be provided as it becomes available.Follow up (08apr2016): new information received from a health insurance company of the patient included patient's date of birth and reaction data (onset date of event and additional event "after wearing this heatwrap a walnut size burn appeared on the skin").Company clinical evaluation comment: based on the information provided, the events of "walnut-sized burn, heavily exuding wound on the abdomen, where the patch-closure was" as described in this case are considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure, assessed as associated with the use of the device.The device misuse is assessed as non-serious and assessed as associated with the use of the device.This case meets follow-up 10-day eu and 30-day fda reportability.Case comment: based on the information provided, the events of "walnut-sized burn, heavily exuding wound on the abdomen, where the patch-closure was" as described in this case are considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure, assessed as associated with the use of the device.The device misuse is assessed as non-serious and assessed as associated with the use of the device.This case meets follow-up 10-day eu and 30-day fda reportability.

• Brand Name: THERMACARE LOWER BACK & HIP
• Type of Device: DISPOSABLE PACK, HOT
• Manufacturer (Section D): PFIZER CONSUMER HEALTH CARE; albany GA
• Manufacturer (Section G): PFIZER CONSUMER HEALTH CARE; 1231 wyandotte drive; albany GA 31705
• Manufacturer Contact: b green ; 235 e42nd street; new york, NY 10017 ; 2127334552
• MDR Report Key: 5555243
• MDR Text Key: 42191050
• Report Number: 1066015-2016-00061
• Device Sequence Number: 1
• Product Code: IMD
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K953442
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Reporter Occupation: Patient
• Type of Report: Initial,Followup,Followup
• Report Date: 03/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/29/2016
• Initial Date FDA Received: 04/07/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 04/21/2016; 05/06/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 63 YR