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

Lot Number W91243

Device Problems Labelling, Instructions for Use or Training Problem (1318); Use of Device Problem (1670); Packaging Problem (3007)

Patient Problems Pain (1994); Skin Irritation (2076); Partial thickness (Second Degree) Burn (2694)

Event Date 02/27/2019

Event Type  Injury  

Event Description

Event verbatim [preferred term] burn marks and blisters on stomach from where the heat wrap had been positioned [burns second degree], there are no warnings on the packaging to advice no direct skin contact to prevent these issues so the patient wouldn't of expected this to happen [product packaging issue], diagnosed with endometriosis/brought this product to give some relief from the constant pain/ placed the head wrap around stomach area [device use issue].Case narrative: this is a spontaneous report from a contactable consumer.A female patient of an unspecified age started to receive thermacare heatwrap (thermacare lower back & hip) from an unspecified date at an unspecified frequency for an unspecified indication.Medical history included endometriosis.Concomitant medication was not reported.The patient was diagnosed with endometriosis and had brought this product to give themselves some relief from the constant pain they suffer.Having previously used these in the past with no issues the patient continued to purchase product for the past 3 months.However, day before the time of reporting was a different experience completely ((b)(6) 2019).The patient placed the head wrap around stomach area in the morning, did not feel any discomfort, any extreme heat and went about daily tasks as normal.When returned home, removed the heat wrap, only to discover burn marks and blisters on stomach from where the heat wrap had been positioned.This had now caused more pain as the blisters and burns were very sore and tender.The patient had to purchase some specific patches to ease the pain.The patient was extremely concerned and dissatisfied with product, as there are no warnings on the packaging to advice no direct skin contact to prevent these issues so the patient wouldn't of expected this to happen.The patient expressed their dissatisfaction with the product and since using it blisters have appeared and patient had been in pain wearing every day clothes was a struggles as they rest against the blisters causing further pain and irritation, meaning had to spend more money on to buy dressings to put over the blisters so can go about day to day life.The action taken in response to the events for thermacare heatwrap was unknown.The 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 of "burn blisters" and "product package issue" as described are considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.The event "device use issue" is non-serious.The events are medically assessed as associated with the use of the device.Comment: based on the information provided, the events of "burn blisters" and "product packaging issue" as described are considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.The event "device use issue" is non-serious.The events are medically assessed as associated with the use of the device.

Event Description

Event verbatim [preferred term] burn marks and blisters on stomach from where the heat wrap had been positioned [burns second degree] , there are no warnings on the packaging to advice no direct skin contact to prevent these issues so the patient wouldn't of expected this to happen [product packaging issue] , diagnosed with endometriosis/brought this product to give some relief from the constant pain/ placed the head wrap around stomach area [device use error] ,.Case narrative:this is a spontaneous report from a contactable consumer.A female patient of an unspecified age started to receive thermacare heatwrap (thermacare lower back & hip) batch # w91243, expiration date jul2021, from an unspecified date at an unspecified frequency for endometriosis constant pain.Medical history included endometriosis.Concomitant medication was not reported.The patient was diagnosed with endometriosis and had bought this product to give themselves some relief from the constant pain they suffer.Having previously used these in the past with no issues the patient continued to purchase product for the past 3 months.However, day before the time of reporting was a different experience completely (b)(6) 2019.The patient placed the heat wrap around stomach area in the morning, did not feel any discomfort or any extreme heat and went about daily tasks as normal.When she returned home, she removed the heat wrap only to discover burn marks and blisters on her stomach from where the heat wrap had been positioned.This had now caused more pain as the blisters and burns were very sore and tender.The patient had to purchase some specific patches to ease the pain.The patient was extremely concerned and dissatisfied with product, as there are no warnings on the packaging to advise no direct skin contact to prevent these issues so the patient wouldn't have expected this to happen.The patient expressed their dissatisfaction with the product and since using it blisters appeared and she had been in pain.Wearing every day clothes was a struggle as they rest against the blisters causing further pain and irritation, meaning had to spend more money to buy dressings to put over the blisters so can go about day to day life.The action taken in response to the events for thermacare heatwrap was unknown.The outcome of the events was unknown.According to product quality complaint group, batch w91243 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.The visual inspection of one retain sample included 2 pouches and the 2 wraps inside.Inspection shows no obvious defects to pouches.Inspection shows no obvious defects to pouches or wraps.(b)(4) retain sample inspection form documented the retain evaluation performed on 04-feb-2019.An evaluation of the complaint history confirms that this is the first complaint for the sub class adverse event safety request for investigation received at the albany site requiring an evaluation for this batch.On the basis of this evaluation, a trend does not exist for this batch.Review of the batch device history record for this batch concludes all release requirements were met.The review of the manufacturing attributes and variables quality checks associated with this batch indicates that all required in process inspections were performed and all inspection criteria were met.There were no wrap attribute or variable defects recorded for the batch.Thermal data for the batch shows all wraps met the required wrap batch average temperatures.This batch has been reviewed from a manufacturing perspective.There are no known site investigations associated with this batch.The root cause category is non-assignable (complaint not confirmed as a quality defect).Evaluation of the return sample does not support the complaint of how the consumer received burns/blisters.After a review of the batch thermal records, thermal results all met product release criteria.Consumer reports an adverse event due to burn/blisters.The cause of the adverse event is inconclusive since review of records does not provide evidence to support defective product.The product effect may vary with each individual.Care should be taken when using the device, following all safety and use information as provided with the wrap to avoid the risks of burns or other skin irritations.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.The product quality for the batch is not impacted by this complaint.Amendment: this follow-up report is being submitted to amend previously reported information: addition of batch number and expiry date.Follow-up (24apr2019): new information received from product quality complaint group included investigational results and expiry date updated., comment: based on the information provided, the events of "burn blisters", "product packaging issue" and "device use error" as described are considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.The events are medically assessed as associated with the use of the device.The review of the lot/batch records does not suggest a defect or quality issue related to the manufacture of this lot.The product quality for the batch is not impacted by this complaint.No device malfunction has been identified.Product effect varies with each individual.In the case narrative there is evidence of a product packaging issue and device use error which most likely contributed to this incident.No remedial action/corrective action/field safety corrective action is suggested at this time.

Manufacturer Narrative

Batch w91243 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.The visual inspection of one retain sample included 2 pouches and the 2 wraps inside.Inspection shows no obvious defects to pouches.Inspection shows no obvious defects to pouches or wraps.(b)(4) retain sample inspection form documented the retain evaluation performed on 04-feb-2019.An evaluation of the complaint history confirms that this is the first complaint for the sub class adverse event safety request for investigation received at the albany site requiring an evaluation for this batch.On the basis of this evaluation, a trend does not exist for this batch.Review of the batch device history record for this batch concludes all release requirements were met.The review of the manufacturing attributes and variables quality checks associated with this batch indicates that all required in process inspections were performed and all inspection criteria were met.There were no wrap attribute or variable defects recorded for the batch.Thermal data for the batch shows all wraps met the required wrap batch average temperatures per (b)(4), effective date: 10-aug-2018.This batch has been reviewed from a manufacturing perspective.There are no known site investigations associated with this batch.The root cause category is non-assignable (complaint not confirmed as a quality defect).Evaluation of the return sample does not support the complaint of how the consumer received burns/blisters.After a review of the batch thermal records, thermal results all met product release criteria.Consumer reports an adverse event due to burn/blisters.The cause of the adverse event is inconclusive since review of records does not provide evidence to support defective product.The product effect may vary with each individual.Care should be taken when using the device, following all safety and use information as provided with the wrap to avoid the risks.

Event Description

Burn marks and blisters on stomach from where the heat wrap had been positioned [burns second degree], there are no warnings on the packaging to advice no direct skin contact to prevent these issues so the patient wouldn't of expected this to happen [product packaging issue], diagnosed with endometriosis/brought this product to give some relief from the constant pain/ placed the head wrap around stomach area [device use issue].Case narrative: this is a spontaneous report from a contactable consumer.A female patient of an unspecified age started to receive thermacare heatwrap (thermacare lower back & hip) batch # w91243, expiration date aug2026, from an unspecified date at an unspecified frequency for endometriosis constant pain.Medical history included endometriosis.Concomitant medication was not reported.The patient was diagnosed with endometriosis and had brought this product to give themselves some relief from the constant pain they suffer.Having previously used these in the past with no issues the patient continued to purchase product for the past 3 months.However, day before the time of reporting was a different experience completely (27feb2019).The patient placed the head wrap around stomach area in the morning, did not feel any discomfort, any extreme heat and went about daily tasks as normal.When returned home, removed the heat wrap, only to discover burn marks and blisters on stomach from where the heat wrap had been positioned.This had now caused more pain as the blisters and burns were very sore and tender.The patient had to purchase some specific patches to ease the pain.The patient was extremely concerned and dissatisfied with product, as there are no warnings on the packaging to advice no direct skin contact to prevent these issues so the patient wouldn't of expected this to happen.The patient expressed their dissatisfaction with the product and since using it blisters have appeared and patient had been in pain wearing every day clothes was a struggles as they rest against the blisters causing further pain and irritation, meaning had to spend more money on to buy dressings to put over the blisters so can go about day to day life.The action taken in response to the events for thermacare heatwrap was unknown.The outcome of the events was unknown.Additional information has been requested and will be provided as it becomes available.Amendment: this follow-up report is being submitted to amend previously reported information: addition of batch number and expiry date.Company clinical evaluation comment: based on the information provided, the events of "burn blisters" and "product package issue" as described are considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.The event "device use issue" is non-serious.The events are medically assessed as associated with the use of the device.Comment: based on the information provided, the events of "burn blisters" and "product packaging issue" as described are considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.The event "device use issue" is non-serious.The events are medically assessed as associated with the use of the device.

• 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
• MDR Report Key: 8396116
• MDR Text Key: 138075934
• Report Number: 1066015-2019-00057
• Device Sequence Number: 1
• Product Code: IMD
• Combination Product (y/n): N
• PMA/PMN Number: K953442
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Type of Report: Initial,Followup,Followup
• Report Date: 02/28/2019
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/01/2021
• Device Lot Number: W91243
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/06/2019
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 03/12/2019; 05/02/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention