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

Lot Number N31957

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Fluid Discharge (2686); Partial thickness (Second Degree) Burn (2694)

Event Date 03/08/2017

Event Type  Injury  

Event Description

Second degree burns.Case narrative:this is a spontaneous report from a contactable consumer.A (b)(6) female patient of an unspecified ethnicity started to receive thermacare heatwrap (thermacare heatwrap), device lot number n31957, expiration date aug2019, ndc number: (b)(4) upc number: (b)(4), via an unspecified route of administration from an unspecified date at an unspecified dose for an unspecified indication.The patient medical history and concomitant medications were not reported.The patient experienced second degree burns from using the thermacare heatwrap on an unspecified date.Consumer mentioned she had to go to the urgent care and she got some fluid out where the burn was and they gave her a tetanus shot as well.The action taken for the product and event outcome was unknown.Additional information has been requested and will be provided as it becomes available.Company clinical evaluation comment based on the information provided, the event "second degree burns" as described in this case is considered a serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure, and the event is assessed as associated with the use of the device.Comment: based on the information provided, the event "second degree burns" as described in this case is considered a serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure, and the event is assessed as associated with the use of the device.

Event Description

Event verbatim [preferred term].Second degree burns/pain [burns second degree].Case narrative: this is a spontaneous report from a contactable consumer.A (b)(6) -year-old female patient of an unspecified ethnicity started to receive thermacare heatwrap (thermacare heatwrap), device lot number n31957, expiration date aug2019, ndc number: (b)(4), upc number: (b)(4), via an unspecified route of administration from an unspecified date at an unspecified dose for an unspecified indication.The patient medical history and concomitant medications were not reported.Consumer stated that she had used the wraps for a while and experienced second degree burns on an unspecified date.Consumer mentioned she had to go to the urgent care and she got some fluid out where the burn was and they gave her a tetanus shot as well.Consumer stated that she was still in pain.The action taken for the product was unknown.Event outcome was not recovered.Additional information has been requested and will be provided as it becomes available.Follow-up (13mar2017): new information received from a contactable consumer included: event details and outcome.Company clinical evaluation comment based on the information provided, the event "second degree burns" as described in this case is considered a serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure, and the event is assessed as associated with the use of the device., comment: based on the information provided, the event "second degree burns" as described in this case is considered a serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure, and the event is assessed as associated with the use of the device.

Manufacturer Narrative

The root cause category is non-assignable (complaint not confirmed).The plant has reviewed this batch from a manufacturing perspective.No quality issues were identified upon this review of batch records, release testing data or, inspection of retained samples.Retained samples met the product description and the product is within expiration date.After a review of the batch thermal records, thermal results all met product release criteria.Consumer alleges burn from wrap.The cause of the alleged bum is inconclusive since review of records does not provide evidence to support defective product.The product effect may vary with each individual.

Event Description

Event verbatim [preferred term] second degree burns/pain [burns second degree].Case narrative:this is a spontaneous report from a contactable consumer.A (b)(6) female patient of an unspecified ethnicity started to receive thermacare heatwrap (thermacare lower back & hip, previously reported as thermacare heatwrap), device lot number n31957, expiration date aug2019, ndc number: (b)(4), upc number: (b)(4), sap/unique identifier: (b)(4), via an unspecified route of administration from an unspecified date at an unspecified dose for an unspecified indication.The patient medical history and concomitant medications were not reported.Consumer stated that she had used the wraps for a while and experienced second degree burns on an unspecified date.Consumer mentioned she had to go to the urgent care and she got some fluid out where the burn was and they gave her a tetanus shot as well.Consumer stated that she was still in pain.The action taken for the product was unknown.Event outcome was not recovered.According to the product quality complaint group: the root cause category is non-assignable (complaint not confirmed).The plant has reviewed this batch from a manufacturing perspective.No quality issues were identified upon this review of batch records, release testing data or, inspection of retained samples.Retained samples met the product description and the product is within expiration date.After a review of the batch thermal records, thermal results all met product release criteria.Consumer alleges burn from wrap.The cause of the alleged bum is inconclusive since review of records does not provide evidence to support defective product.The product effect may vary with each individual.Additional information has been requested and will be provided as it becomes available.Follow-up (13mar2017): new information received from a contactable consumer included: event details and outcome.Follow-up (18apr2017): new information received from the product quality complaint group included investigational results.In addition, suspect product name updated from thermacare heatwrap to thermacare lower back & hip.Company clinical evaluation comment: based on the information provided, the event second degree burns as described in this case is considered a serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure, and the event is assessed as associated with the use of the device.No device malfunction has been identified.Comment: based on the information provided, the event "second degree burns" as described in this case is considered a serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure, and the event is assessed as associated with the use of the device.No device malfunction has been identified.

Manufacturer Narrative

The root cause category is non-assignable (complaint not confirmed).The plant has reviewed this batch from a manufacturing perspective.No quality issues were identified upon this review of batch records, release testing data or, inspection of retained samples.Retained samples met the product description and the product is within expiration date.After a review of the batch thermal records, thermal results all met product release criteria.Consumer alleges burn from wrap.The cause of the alleged bum is inconclusive since review of records does not provide evidence to support defective product.The product effect may vary with each individual.

Event Description

Event verbatim [preferred term] second degree burn on her lower back/pain [burns second degree], left ugly scars, she applied the product directly to the skin and wrapped around her lower back [device use error],.Case narrative:this is a spontaneous report from a contactable consumer.A (b)(6) year-old female patient of an unspecified ethnicity started to receive thermacare heatwrap (thermacare lower back & hip, previously reported as thermacare heatwrap), device lot number n31957, expiration date aug2019, ndc number: (b)(4), upc number: (b)(4), sap/unique identifier: us (b)(4), via an unspecified route of administration from an unspecified date at an unspecified dose for an unspecified indication.The patient medical history and concomitant medications were not reported.Consumer stated that she had used the wraps for a while and experienced second degree burns on an unspecified date.Consumer mentioned she had to go to the urgent care and she got some fluid out where the burn was and they gave her a tetanus shot as well.Consumer stated that she was still in pain.The action taken for the product was unknown.Event outcome was not recovered.According to the product quality complaint group: the root cause category is non-assignable (complaint not confirmed).The plant has reviewed this batch from a manufacturing perspective.No quality issues were identified upon this review of batch records, release testing data or, inspection of retained samples.Retained samples met the product description and the product is within expiration date.After a review of the batch thermal records, thermal results all met product release criteria.Consumer alleges burn from wrap.The cause of the alleged bum is inconclusive since review of records does not provide evidence to support defective product.The product effect may vary with each individual.Additional information has been requested and will be provided as it becomes available.Follow-up (13mar2017): new information received from a contactable consumer included: event details and outcome.Follow-up (18apr2017): new information received from the product quality complaint group included investigational results.In addition, suspect product name updated from thermacare heatwrap to thermacare lower back & hip.Company clinical evaluation comment: based on the information provided, the event second degree burns as described in this case is considered a serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure, and the event is assessed as associated with the use of the device.No device malfunction has been identified.Follow-up (11may17): follow-up attempts are completed.No further information is expected.Follow-up (24jul2017): this contactable consumer reported by way of medical records and consumer questionnaire.This african american female patient applied thermacare heatwrap (thermacare lower back and hip) between 2 to 4 hours on (b)(6) 2017 for lower back pain.The relevant medical history included insulin-dependent diabetes mellitus/diabetes, poor circulation (sometimes) and hypertension on an unknown date.The social history included occasionally alcohol consumption on an unknown date.The family history included aneurysm and prostate cancer for father, congestive heart failure (chf), chronic obstructive pulmonary disease (copd), diabetes mellitus, hypertension and rheumatoid arthritis for mother on an unknown date.On (b)(6) 2017, she applied the product directly to the skin and wrapped around her lower back.On (b)(6) 2017, she experienced a second degree burn on her lower back, irritation, fluid filled blisters on lower back, burn, pain and stiffness.Her burns took months for healing and left ugly scars on unknown date.She took off the product when detected irritation and discontinued the use of product on (b)(6) 2017.On an unknown date, she underwent unknown testing for which results were unknown and was hospitalized.She underwent treatment with unknown medication for burns and scars.It was reported that, the product was left on at one time for up to 16 hours during the course of 24 hours.The product was not re-heated during usage.She did not leave the product on while she was a sleep.The skin was not damaged or broken prior to usage of product.As of (b)(6) 2017, the clinical outcome of the event left ugly scars was not recovered and second degree burn on her lower back/pain was recovering and she applied the product directly to the skin and wrapped around her lower back was unknown.

• Brand Name: THERMACARE LOWER BACK & HIP
• Type of Device: DISPOSABLE PACK, HOT
• Manufacturer (Section D): PFIZER CONSUMER HEALTH CARE; 1231 wyandotte drive; albany GA 31705
• Manufacturer Contact: b green ; 235 e42nd street; new york, NY 10017
• MDR Report Key: 6406202
• MDR Text Key: 70009465
• Report Number: 1066015-2017-00057
• Device Sequence Number: 1
• Product Code: IMD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K953442
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/09/2017

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
• Device Expiration Date: 08/01/2019
• Device Lot Number: N31957
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/15/2017
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 03/17/2017; 04/21/2017; 07/28/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 44 YR