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

Lot Number L16817

Device Problems Use of Device Problem (1670); Insufficient Information (3190)

Patient Problems Pain (1994); Rupture (2208); Partial thickness (Second Degree) Burn (2694)

Event Date 11/01/2016

Event Type  Injury  

Event Description

Event verbatim [preferred term] the blisters are not dry yet, liquid is coming out [blister rupture] , they hurt [pain] , did not check her skin under the product while wearing the heatwrap [intentional device misuse] ,.Case narrative:this is a spontaneous report from a contactable consumer or other non hcp.A (b)(6) female patient of an unspecified ethnicity started to use thermacare heatwrap (thermacare lower back & hip) (device lot number: l16817, expiration date: dec2017) from (b)(6) 2016 for sore back.Medical history included heart disease from an unknown date and unknown if ongoing (has a pacemaker and a defibrillator) and sensitive skin from an unspecified date and ongoing.There were no concomitant medications.The patient reported she used the heatwrap for the first time on (b)(6) 2016 for 8 hours and took the heatwrap off.She noticed blisters had formed all around where she had the wrap around her waist the next morning when she went to take a shower, (b)(6) 2016.She stated the blisters are not dry yet, liquid is coming out and they hurt.The patient reported she did not check her skin under the product while wearing the heatwrap.The patient consulted her pharmacist in regards to the adverse events.She stated her pharmacist is sending her benadryl.The patient assessed her skin tone as medium (neither light nor dark).She denied having any abnormal skin conditions.The patient denied having atopic dermatitis, eczema, seborrheic dermatitis, skin allergies and hives or rashes.She denied having the following conditions: diabetes, poor circulation, difficulty feeling heat or pain on her skin, rheumatoid arthritis, decreased sensitization and neuropathy.The patient previously used a heating pad for pain relief about a year ago for about a half hour with no adverse effect.She is currently under the care of a physician for her heart issues.The patient was not sleeping while wearing the wrap and did not wear several layers of clothing over the wrap during use.She denied wearing a snug waist band/belt or similar or otherwise applied pressure over the area during wrap usage.The patient read the usage instructions for the heatwrap prior to use and did not engage in exercise while using the wrap.She was not taking any medications (including over the counter, herbal, nutritional or any applied to the skin) during the time the problems/symptoms were experienced.Action taken with the suspect product was permanently withdrawn on (b)(6) 2016.It was unknown if therapeutic measures were taken as a result of the events.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 available information, the events of 'patient did not did not check her skin under the product while wearing the heatwrap and developed blisters that are not dry yet, liquid is coming out and they hurt' 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., comment: based on the available information, the events of 'patient did not did not check her skin under the product while wearing the heatwrap and developed blisters that are not dry yet, liquid is coming out and they hurt' 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.

Manufacturer Narrative

Conclusion: the root cause category is non assignable (complaint not confirmed as a quality defect).After a review of the batch thermal records, thermal results all met product release criteria.Consumer reports noticing "blisters." the cause of the consumer statement 'noticed blisters', is inconclusive.The review of records does not provide evidence to support the defective product.The product effect may vary with each individual.The plant has reviewed this batch from a manufacturing perspective.No quality issues were identified upon this review of batch records and release testing data.The product quality for the batch is not impacted by this complaint.Batch l16817 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.Review of the batch device history record for this batch concludes all release requirements were met.The batch was manufactured over a four day production period.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.All wraps met the required temperature specifications (37.6°c-41.6°c).There were no variable defects recorded for the batch.This batch has been reviewed from a manufacturing perspective.There are no known site investigations associated with this batch.An evaluation of the compliant history confirms that this is first complaint for the subclass adverse event safety request for investigation received at the site requiring an evaluation for this batch.The complaint was evaluated to identify any potential trend.The complaints per million produced (cpmp) result of 18 for this batch is below he upper control limit is 33.9.On the basis of this evaluation, a trend does not exist for this batch.Reasonably suggest device malfunction?: no.Severity of harm: n/a.Site sample status was not received.

Event Description

Event verbatim [preferred term] the blisters are not dry yet, liquid is coming out [blister rupture], they hurt [pain], did not check her skin under the product while wearing the heatwrap [intentional device misuse], narrative: this is a spontaneous report from a contactable consumer or other non healthcare professional.A 72-year-old female patient started to use thermacare heatwrap (thermacare lower back & hip) (bonus 2+ 1 ct carton) (device lot number: l16817, expiration date: 31dec2017) from (b)(6) 2016 for sore back.Medical history included heart disease from an unknown date and unknown if ongoing (has a pacemaker and a defibrillator) and sensitive skin from an unspecified date and ongoing.There were no concomitant medications.The patient reported she used the heatwrap for the first time on (b)(6) 2016 for 8 hours and took the heatwrap off.She noticed blisters had formed all around where she had the wrap around her waist the next morning when she went to take a shower, (b)(6) 2016.She stated the blisters are not dry yet, liquid is coming out and they hurt.The patient reported she did not check her skin under the product while wearing the heatwrap.The patient consulted her pharmacist in regards to the adverse events.She stated her pharmacist is sending her benadryl.The patient assessed her skin tone as medium (neither light nor dark).She denied having any abnormal skin conditions.The patient denied having atopic dermatitis, eczema, seborrheic dermatitis, skin allergies and hives or rashes.She denied having the following conditions: diabetes, poor circulation, difficulty feeling heat or pain on her skin, rheumatoid arthritis, decreased sensitization and neuropathy.The patient previously used a heating pad for pain relief about a year ago for about a half hour with no adverse effect.She is currently under the care of a physician for her heart issues.The patient was not sleeping while wearing the wrap and did not wear several layers of clothing over the wrap during use.She denied wearing a snug waist band/belt or similar or otherwise applied pressure over the area during wrap usage.The patient read the usage instructions for the heatwrap prior to use and did not engage in exercise while using the wrap.She was not taking any medications (including over the counter, herbal, nutritional or any applied to the skin) during the time the problems/symptoms were experienced.Action taken with the suspect product was permanently withdrawn on (b)(6) 2016.It was unknown if therapeutic measures were taken as a result of the events.Clinical outcome of the events was not resolved.Product investigation results were as follows: conclusion: the root cause category is non assignable (complaint not confirmed as a quality defect).After a review of the batch thermal records, thermal results all met product release criteria.Consumer reports noticing "blisters." the cause of the consumer statement 'noticed blisters', is inconclusive.The review of records does not provide evidence to support the defective product.The product effect may vary with each individual.The plant has reviewed this batch from a manufacturing perspective.No quality issues were identified upon this review of batch records and release testing data.The product quality for the batch is not impacted by this complaint.Batch l16817 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.Review of the batch device history record for this batch concludes all release requirements were met.The batch was manufactured over a four day production period.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.All wraps met the required temperature specifications (37.6°c-41.6°c).There were no variable defects recorded for the batch.This batch has been reviewed from a manufacturing perspective.There are no known site investigations associated with this batch.An evaluation of the compliant history confirms that this is first complaint for the subclass adverse event safety request for investigation received at the site requiring an evaluation for this batch.The complaint was evaluated to identify any potential trend.The complaints (b)(4) produced (cpmp) result of (b)(4) for this batch is below the upper control limit is (b)(4).On the basis of this evaluation, a trend does not exist for this batch.Reasonably suggest device malfunction?: no.Severity of harm: n/a.Site sample status was not received.Follow-up attempts are completed.No further information is expected.Follow-up (30-dec-2016): follow-up attempts are completed.No further information is expected.Follow up (06jul2020): new information received from a product quality complaints group includes: investigation results.Follow-up attempts are completed.No further information is expected., comment: based on the available information, the events of 'patient did not did not check her skin under the product while wearing the heatwrap and developed blisters that are not dry yet, liquid is coming out and they hurt' 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.

• 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: 6083126
• MDR Text Key: 59295409
• Report Number: 1066015-2016-00144
• 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
• Type of Report: Initial,Followup
• Report Date: 11/03/2016

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
• Device Expiration Date: 12/31/2017
• Device Lot Number: L16817
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/07/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 72 YR
• Patient Weight: 81