MAUDE Adverse Event Report: PFIZER CONSUMER HEALTH CARE THERMACARE HEATWRAPS MULTI-PURPOSE JOINT PAIN; DISPOSABLE PACK, HOT

Lot Number T26681

Device Problems Increase in Pressure (1491); Use of Device Problem (1670)

Patient Problem Partial thickness (Second Degree) Burn (2694)

Event Date 01/27/2018

Event Type  Injury  

Event Description

When she took it off she had two blisters on her shoulder [blister], they are tight [device issue].Case narrative: this is a spontaneous report from a contactable consumer reported for herself.A female patient of an unspecified age and ethnicity started to use thermacare heatwrap (thermacare heatwraps multi-purpose joint pain), lot number: t26681 (n07/17 after lot number), expiration date: jun2020, upc number: 305733017258, from an unspecified date for an unspecified indication.The patient's medical history and concomitant medications were not reported.Past product history included thermacare heatwraps (thermacare heatwraps) from an unspecified date for an unspecified indication with no adverse effect.The patient purchased the product on (b)(6) 2018.On (b)(6) 2018, the patient used the heatwrap on her shoulder and when she took it off she had two blisters on her shoulder.She stated "this is the little wrap one where you can wear either on the shoulder or the ankle or like that and i didn't pulled it up, they were tight and when i took it off i had 2 blisters on my shoulders.I have used the product before that never happened but i don't know if it was the defective one or what i have purchased the box on." she also reported she didn't put it on tight.She took photos of it.It was a 4 pack with a bonus item.Action taken with thermacare heatwrap was unknown.Clinical outcome of the events was unknown.Additional information has been requested and will be provided as it becomes available.Follow-up (30jan2018): new information received from a contactable consumer includes: updated product trade name from thermacare neck, shoulder & wrist to thermacare heatwraps multi-purpose joint pain, provided lot number and expiration date.Follow-up (27feb2019): follow-up attempts are completed.No further information is expected.Follow-up (29jan2018): this follow-up report is being submitted to upgrade this case to a reportable mdr.Company clinical evaluation comment: based on the information provided, the events of "blisters" and "device issue" 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.Comment: based on the information provided, the events of "blisters" and "device issue" 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.

Event Description

Event verbatim [preferred term] when she took it off she had two blisters on her shoulder [blister] , they are tight [device issue].Case narrative:this is a spontaneous report from a contactable consumer reported for herself.A female patient of an unspecified age started to use thermacare heatwrap (thermacare heatwraps multi-purpose joint pain), lot number: t26681 (n07/17 after lot number), expiration date: jun2020, upc number: 305733017258, from (b)(6) 2018 for an unspecified indication.The patient's medical history and concomitant medications were not reported.Past product history included thermacare heatwraps (thermacare heatwraps) from an unspecified date for an unspecified indication with no adverse effect.The patient purchased the product on (b)(6) 2018.On (b)(6) 2018, the patient used the heatwrap on her shoulder and when she took it off she had two blisters on her shoulder.She stated "this is the little wrap one where you can wear either on the shoulder or the ankle or like that and i didn't pulled it up, they were tight and when i took it off i had 2 blisters on my shoulders.I have used the product before that never happened but i don't know if it was the defective one or what i have purchased the box on." she also reported she didn't put it on tight.She took photos of it.It was a 4 pack with a bonus item.Action taken with thermacare heatwrap was unknown.Clinical outcome of the events was unknown.Additional information has been requested and will be provided as it becomes available.Follow-up (30jan2018): new information received from a contactable consumer includes: updated product trade name from thermacare neck, shoulder & wrist to thermacare heatwraps multi-purpose joint pain, provided lot number and expiration date.Follow-up (27feb2019): follow-up attempts are completed.No further information is expected.Follow-up (29jan2018): this follow-up report is being submitted to upgrade this case to a reportable mdr.Amendment: this follow-up report is being submitted to amend previously reported information: unique identifier (udi #) added.Company clinical evaluation comment: based on the information provided, the events of "blisters" and "device issue" 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., comment: based on the information provided, the events of "blisters" and "device issue" 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.

Event Description

Event verbatim [preferred term].When she took it off she had two blisters on her shoulder [blister], they are tight [device issue].Narrative: this is a spontaneous report from a contactable consumer reported for herself.A female patient of an unspecified age started to use thermacare heatwrap (thermacare heatwraps multi-purpose joint pain), lot number: t26681, expiration date: jun2020, upc number: 305733017258, from (b)(6) 2018 for an unspecified indication.The patient's medical history and concomitant medications were not reported.Past product history included thermacare heatwraps (thermacare heatwraps) from an unspecified date for an unspecified indication with no adverse effect.The patient purchased the product on (b)(6) 2018.On (b)(6) 2018, the patient used the heatwrap on her shoulder and when she took it off she had two blisters on her shoulder.She stated "this is the little wrap one where you can wear either on the shoulder or the ankle or like that and i didn't pulled it up, they were tight and when i took it off i had 2 blisters on my shoulders.I have used the product before that never happened but i don't know if it was the defective one or what i have purchased the box on." she also reported she didn't put it on tight.She took photos of it.It was a 4 pack with a bonus item.Action taken with thermacare heatwrap was unknown.Clinical outcome of the events was unknown.According to product quality complaint group, batch t26681 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.After a review of the batch thermal records the root cause category is non assignable and complaint not confirmed as a quality defect.The batch thermal results met all product release criteria.The consumer reported the wrap caused "two blisters to the shoulder." the cause of the consumer burns is inconclusive since review of the records does not provide evidence to support defective product.The effect of the product 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, 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.Lot trend assessment and rationale: an evaluation of the complaint history confirms that this is the second complaint for the sub class adverse event safety request for investigation received at the albany site requiring an evaluation for this batch.The previous complaint was not confirmed to have a manufacturing root cause for the complaint.The complaint was evaluated to identify any potential trend for the lot and subclass.The calculated complaints per million produced (cpmp) result was 25.This result was below control limit (ucl) of 33.9 complaints per sop-# complaint trending guideline, effective (b)(6) 2020.On the basis of this evaluation, a trend does not exist for this batch.Site sample status was not received.Follow-up (30jan2018): new information received from a contactable consumer includes: updated product trade name from thermacare neck, shoulder & wrist to thermacare heatwraps multi-purpose joint pain, provided lot number and expiration date.Follow-up (27feb2019): follow-up attempts are completed.No further information is expected.Follow-up (29jan2018): this follow-up report is being submitted to upgrade this case to a reportable mdr.Amendment: this follow-up report is being submitted to amend previously reported information: unique identifier (udi #) added.Follow-up (19dec2019): follow-up attempts are completed.No further information is expected.Follow-up (15apr2020): new information received from a product quality complaint group included: investigation result.Follow-up attempts are completed.No further information is expected.Comment: based on the information provided, the events of "blisters" and "device issue" 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.No quality issues were identified upon this review of batch records, release testing data or, inspection of retained samples.The root cause category is non-assignable and complaint not confirmed as a quality defect.Product effect varies with each individual.No further investigations or actions are suggested at this time.

Manufacturer Narrative

Batch t26681 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.After a review of the batch thermal records the root cause category is non assignable and complaint not confirmed as a quality defect.The batch thermal results met all product release criteria.The consumer reported the wrap caused "two blisters to the shoulder." the cause of the consumer burns is inconclusive since review of the records does not provide evidence to support defective product.The effect of the product 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, 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.Lot trend assessment and rationale: an evaluation of the complaint history confirms that this is the second complaint for the sub class adverse event safety request for investigation received at the albany site requiring an evaluation for this batch.The previous complaint was not confirmed to have a manufacturing root cause for the complaint.The complaint was evaluated to identify any potential trend for the lot and subclass.The calculated complaints per million produced (cpmp) result was 25.This result was below control limit (ucl) of 33.9 complaints per sop-# complaint trending guideline, effective (b)(6) 2020.On the basis of this evaluation, a trend does not exist for this batch.Site sample status was not received.

• Brand Name: THERMACARE HEATWRAPS MULTI-PURPOSE JOINT PAIN
• Type of Device: DISPOSABLE PACK, HOT
• Manufacturer (Section D): PFIZER CONSUMER HEALTH CARE; 1231 wyandotte drive; albany GA 31705
• MDR Report Key: 9257937
• MDR Text Key: 180852589
• Report Number: 1066015-2019-00264
• 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,Followup
• Report Date: 01/29/2018

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?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/01/2020
• Device Lot Number: T26681
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/30/2019
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 12/02/2019; 04/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention