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

Lot Number M19507

Device Problems Patient-Device Incompatibility (2682); Temperature Problem (3022)

Patient Problems Inflammation (1932); Itching Sensation (1943)

Event Date 01/01/2016

Event Type  Injury  

Event Description

Physician was unsure if it was a burn [thermal burn].Blisters on the affected area [blister].Skin is itchy and inflamed [pruritus].Skin is itchy and inflamed [dermatitis].Treating the irritation with aloe vera [skin irritation].Case description: this is a spontaneous report from a contactable consumer.A female patient of an unspecified age and ethnicity started to use thermacare heatwrap (thermacare lower back & hip) (batch number m19507, expiry date jul2018) on an unspecified date, at an unspecified frequency, for an unspecified indication.No medical history or concomitant medications were reported.Past product history included thermacare heatwrap and had no problems.The patient bought two back pain wraps.She stated she followed the instructions and wore them over her shirt.She was wearing the wrap on her lower back / side.She had experienced a reaction to the product and her skin was itchy and inflamed.There were blisters on the affected area.This occurred about 7 days prior to this report ((b)(6) 2016).She stated that she used the first wrap, and had no problems.She then wore the second wrap a day later for about 5 hours and experienced a reaction.She spoke to her physician and her pharmacist.Her physician was not sure if it was a burn.She was treating the irritation with aloe vera.The action taken in response to the event for thermacare heatwrap and outcome of the events 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 events burn and blisters on the affected area 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 events of irritation, skin is itchy and inflamed are 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 burn and blisters on the affected area 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 events of irritation, skin is itchy and inflamed are 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.A female patient of an unspecified age and ethnicity started to use thermacare heatwrap (thermacare lower back & hip) (batch number (b)(4), expiry date jul2018) on an unspecified date, at an unspecified frequency, for an unspecified indication.No medical history or concomitant medications were reported.Past product history included thermacare heatwrap and had no problems.The patient bought two back pain wraps.She stated she followed the instructions and wore them over her shirt.She was wearing the wrap on her lower back / side.She had experienced a reaction to the product and her skin was itchy and inflamed.There were blisters on the affected area.This occurred about 7 days prior to this report ((b)(6) 2016).She stated that she used the first wrap, and had no problems.She then wore the second wrap a day later for about 5 hours and experienced a reaction.She spoke to her physician and her pharmacist.Her physician was not sure if it was a burn.She was treating the irritation with aloe vera.The action taken in response to the event for thermacare heatwrap and outcome of the events was unknown.Additional information has been requested and will be provided as it becomes available.Follow up ((b)(6) 2016): this case is being submitted to amend previously reported information (the reported batch number was entered as the lot number).Company clinical evaluation comment: based on the information provided, the events burn and blisters on the affected area 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 events of irritation, skin is itchy and inflamed are 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 burn and blisters on the affected area 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 events of irritation, skin is itchy and inflamed are assessed as associated with the use of the device.This case meets follow up 10-day eu and 30-day fda reportability.

Manufacturer Narrative

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 burn is inconclusive since review of records does not provide evidence to support defective product.Care should be taken to use the device as it was designed, following all safety and use information as provided with the wrap to avoid the risks of burns or other skin irritations.The product effect may vary with each individual.

Event Description

Case description: this is a spontaneous report from a contactable consumer.A female patient of an unspecified age and ethnicity started to use thermacare heatwrap (thermacare lower back & hip) (batch number m19507, expiry date jul2018) on an unspecified date, at an unspecified frequency, for an unspecified indication.No medical history or concomitant medications were reported.Past product history included thermacare heatwrap and had no problems.The patient bought two back pain wraps.She stated she followed the instructions and wore them over her shirt.She was wearing the wrap on her lower back/side.She had experienced a reaction to the product and her skin was itchy and inflamed.There were blisters on the affected area.This occurred about 7 days prior to this report ((b)(6) 2016).She stated that she used the first wrap, and had no problems.She then wore the second wrap a day later for about 5 hours and experienced a reaction.She spoke to her physician and her pharmacist.Her physician was not sure if it was a burn.She was treating the irritation with aloe vera.Action taken in response to the event for thermacare heatwrap was unknown.Clinical outcome of the events was unknown.New information received from product quality complaint (pqc) group includes investigation results.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 burn is inconclusive since review of records does not provide evidence to support defective product.Care should be taken to use the device as it was designed, following all safety and use information as provided with the wrap to avoid the risks of burns or other skin irritations.The product effect may vary with each individual.Additional information has been requested and will be provided as it becomes available.Follow up (11feb2016): this case is being submitted to amend previously reported information (the reported batch number was entered as the lot number).Follow-up (17feb2016): new information received from product quality complaints (pqc) group included: product quality investigation results.Company clinical evaluation comment: based on the information provided, the events burn and blisters on the affected area 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 events of irritation, skin is itchy and inflamed are assessed as associated with the use of the device.This case meets (b)(6) and 30-day fda reportability.Case comment: based on the information provided, the events burn and blisters on the affected area 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 events of irritation, skin is itchy and inflamed are assessed as associated with the use of the device.This case meets (b)(6) and 30-day fda reportability.Evaluation summary: 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 burn is inconclusive since review of records does not provide evidence to support defective product.Care should be taken to use the device as it was designed, following all safety and use information as provided with the wrap to avoid the risks of burns or other skin irritations.The product effect may vary with each individual.

• 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: 5434089
• MDR Text Key: 38137878
• Report Number: 1066015-2016-00019
• Device Sequence Number: 1
• Product Code: IMD
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 01/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/01/2018
• Device Lot Number: M19507
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/17/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention