MAUDE Adverse Event Report: PFIZER CONSUMER HEALTH CARE THERMACARE HEATWRAP; DISPOSABLE PACK, HOT

Lot Number M32656

Device Problem Defective Device (2588)

Patient Problems Purulent Discharge (1812); Partial thickness (Second Degree) Burn (2694)

Event Type  Injury  

Event Description

Second degree burns (got one big blister and lot of red spots on her back/burn with blistering) [burns second degree].Drainage of pus [wound drainage].Used the defective product that burnt her [product quality issue].Case description: this is a spontaneous report from a contactable nurse on behalf of herself.A black female patient of an unspecified age started to use thermacare heatwrap (thermacare heatwrap), device lot number m32656, expiration date aug2018, from an unspecified date to an unspecified date at an unknown frequency for an unspecified indication.The patient medical history was not reported.The patient's concomitant medications were not reported.Past product history included thermacare heatwrap (thermacare heatwrap) on and off for many years with no adverse effects.The patient experienced very bad burns on her back, the size of the burn was as big as 25 "cents", got one big blister and lot of red spots on her back.She stated that it was a defective product that burnt her because never had a burn before and she really had a burn.She said that there was drainage of pus and it was a second degree burn.She had burn with blistering, she did not have rashes on an unspecified date with outcome of unknown.The action taken with thermacare heatwrap was unknown.She said that her skin tone was brown and she did not use any creams, rubs or gels under the product and added that she used it on the clean dry skin.She said that she did not see cuts, tears, leaks or holes on the product when she put it on and she did not put the product in the microwave.She said that she did not know about the color change of the product and she did not exercise while using the product and added that she was using as she always used.Nothing was leaking from that product.She said that she did not change or modify the product in anyway and she did not use the product overnight, she used it in the day time.She said that she used the product over healthy skin and she said that the box did not say where to use the product but she always used it the same way.She did not apply any pressure over the product.She said that she did not wear more than two layers of clothing over the product.She did not sit or recline for a prolonged period of time.She used it when she went for a walk and she did not use more than one every day, when she used it she use one.When it was time to take it off, it seemed like it was little hot but it always had been hot when she took it off because she never kept it on for more than 4 or 5 hours.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 second degree burn with drainage and pus from using a defective product 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.This case meets initial 10-day eu and 30-day fda reportability.Case comment: based on the information provided, the events of second degree burn with drainage and pus from using a defective product 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.This case meets initial 10-day eu and 30-day fda reportability.

Manufacturer Narrative

The root cause category is non-assignable (complaint not confirmed).Consumer alleges wrap was too hot.The cause of the wrap being too hot is inconclusive since review of records does not provide evidence to support defective product.The product effect may vary with each individual.The plant has reviewed this batch from a manufacturing and technical 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.Note: approval of sqol and opu ql is not required because the complaint was not confirmed.Process related: no, complaint confirmed: no, design related: no.

Event Description

Case description: this is a spontaneous report from a contactable nurse on behalf of herself.A black female patient of an unspecified age started to use thermacare heatwrap (thermacare heatwrap), device lot number m32656, expiration date aug2018, from an unspecified date to an unspecified date at an unknown frequency for an unspecified indication.The patient medical history was not reported.The patient's concomitant medications were not reported.Past product history included thermacare heatwrap (thermacare heatwrap) on and off for many years with no adverse effects.The patient experienced very bad burns on her back, the size of the burn was as big as 25 "centis", got one big blister and lot of red spots on her back.She stated that it was a defective product that burnt her because never had a burn before and she really had a burn.She said that there was drainage of pus and it was a second degree burn.She had burn with blistering, she did not have rashes on an unspecified date with outcome of unknown.The action taken with thermacare heatwrap was unknown.She said that her skin tone was brown and she did not use any creams, rubs or gels under the product and added that she used it on the clean dry skin.She said that she did not see cuts, tears, leaks or holes on the product when she put it on and she did not put the product in the microwave.She said that she did not know about the color change of the product and she did not exercise while using the product and added that she was using as she always used.Nothing was leaking from that product.She said that she did not change or modify the product in anyway and she did not use the product overnight, she used it in the day time.She said that she used the product over healthy skin and she said that the box did not say where to use the product but she always used it the same way.She did not apply any pressure over the product.She said that she did not wear more than two layers of clothing over the product.She did not sit or recline for a prolonged period of time.She used it when she went for a walk and she did not use more than one every day, when she used it she use one.When it was time to take it off, it seemed like it was little hot but it always had been hot when she took it off because she never kept it on for more than 4 or 5 hours.Investigation result received from product quality complaints included: the root cause category is non-assignable (complaint not confirmed).Consumer alleges wrap was too hot.The cause of the wrap being too hot is inconclusive since review of records does not provide evidence to support defective product.The product effect may vary with each individual.The plant has reviewed this batch from a manufacturing and technical 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.Note: approval of sqol and opu ql is not required because the complaint was not confirmed.Process related: no, complaint confirmed: no, design related: no.Additional information has been requested and will be provided as it becomes available.Follow-up (13may2016): new information reported from product quality complaints included: investigation result.Follow-up attempts are completed.No further information is expected.Company clinical evaluation comment based on the information provided, the events of second degree burn with drainage and pus from using a defective product 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.This case meets final (b)(6) and 30-day fda reportability.Case comment: based on the information provided, the events of second degree burn with drainage and pus from using a defective product 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.This case meets final (b)(6) and 30-day fda reportability.Evaluation summary the root cause category is non-assignable (complaint not confirmed).Consumer alleges wrap was too hot.The cause of the wrap being too hot is inconclusive since review of records does not provide evidence to support defective product.The product effect may vary with each individual.The plant has reviewed this batch from a manufacturing and technical 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.Note: approval of sqol and opu ql is not required because the complaint was not confirmed.Process related: no, complaint confirmed: no, design related: no.

• Brand Name: THERMACARE HEATWRAP
• 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: 5596594
• MDR Text Key: 43279862
• Report Number: 1066015-2016-00065
• 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: health professional
• Reporter Occupation: Nurse
• Type of Report: Initial,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: Health Professional
• Device Expiration Date: 08/01/2018
• Device Lot Number: M32656
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/29/2016
• Initial Date FDA Received: 04/21/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/27/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Weight: 79