MAUDE Adverse Event Report: PFIZER CONSUMER HEALTH CARE THERMACARE NECK, SHOULDER & WRIST; DISPOSABLE PACK, HOT

Lot Number CH9468

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Physical Resistance/Sticking (4012)

Patient Problems Erythema (1840); Pain (1994)

Event Date 12/04/2019

Event Type  Injury  

Event Description

The area that the wrap was sticking to was kind of painful and red [pain], the area that the wrap was sticking to was kind of painful and red/skin was red/redness [erythema], maybe it was too sticky [device adhesion issue].Case narrative:this is a spontaneous report from a contactable consumer or other non hcp.A (b)(6) female patient started to use thermacare heatwrap (thermacare neck, shoulder & wrist) (device lot number ch9468, expiration date jun2022) from an unspecified date at one wrap placed on neck/shoulder area for 5 hours for neck pain on left side, near shoulder, for muscle spasm.The patient's medical history was reported as none.There were no concomitant medications.On (b)(6) 2019, the patient reported she used the neck wrap this week in the car for 5 hours.When she removed the wrap, she was not burned.The patient stated the area that the wrap was sticking to was kind of painful and her skin was red.She had never had that problem before.She thought maybe it was too sticky.Action taken with the suspect product was permanently withdrawn on an unspecified date in (b)(6) 2019.No therapeutic measures were taken as a result of the events.Clinical outcome of the events was resolving.A sample of the product was not available to be returned; product was discarded.The packaging was sealed and intact.Product quality complaint provided the following severity of harm rating of s3 for "skin redness/ pain." additional information has been requested and will be provided as it becomes available.Follow-up (16dec2019): new information received from product quality complaints includes: severity rating (s3) and product information (sample not available to be returned, packaging was sealed and intact).This follow-up upgrades the case to a reportable mdr.Company clinical evaluation comment: based on the information provided, the events pain, erythema and device adhesion 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 pain, erythema and device adhesion 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] the area that the wrap was sticking to was kind of painful and red [pain] , the area that the wrap was sticking to was kind of painful and red/skin was red/redness [erythema] , maybe it was too sticky [device adhesion issue] ,.Case narrative:this is a spontaneous report from a contactable consumer.A 71-year-old female patient started to use thermacare heatwrap (thermacare neck, shoulder & wrist) (device lot number ch9468, expiration date jun2022) from an unspecified date at one wrap placed on neck/shoulder area for (b)(4) hours for neck pain on left side, near shoulder, for muscle spasm.The patient's medical history was reported as none.There were no concomitant medications.On (b)(6)2019, the patient reported she used the neck wrap this week in the car for (b)(4) hours.When she removed the wrap, she was not burned.The patient stated the area that the wrap was sticking to was kind of painful and her skin was red.She had never had that problem before.She thought maybe it was too sticky.Action taken with the suspect product was permanently withdrawn on an unspecified date in (b)(6)2019.No therapeutic measures were taken as a result of the events.Clinical outcome of the events was resolving.A sample of the product was not available to be returned; product was discarded.The packaging was sealed and intact.Product quality complaint provided the following severity of harm rating of s3 for "skin redness/ pain." additional information has been requested and will be provided as it becomes available.Follow-up (16dec2019): new information received from product quality complaints includes: severity rating (s3) and product information (sample not available to be returned, packaging was sealed and intact).This follow-up upgrades the case to a reportable mdr.Amendment: this follow-up report is being submitted to amend previously reported information: the explanted date was amended to report no date (blank); previously reported with date of 04dec2019.Company clinical evaluation comment: based on the information provided, the events pain, erythema and device adhesion 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 pain, erythema and device adhesion 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] the area that the wrap was sticking to was kind of painful and red [pain] , the area that the wrap was sticking to was kind of painful and red/skin was red/redness [erythema] , maybe it was too sticky [device adhesion issue] , not comfortable [discomfort].Case narrative:this is a spontaneous report from a contactable consumer.A 71-year-old female patient started to use thermacare heatwrap (thermacare neck, shoulder & wrist) (device lot number ch9468, expiration date jun2022) in (b)(6) 2019 at one wrap placed on neck/shoulder area for 5 hours (1 wrap - 1x/day) for neck pain on left side, near shoulder, for muscle spasm/ spasm in neck.The patient's medical history was reported as none.There were no concomitant medications.The patient used the neck wrap "this week" in the car for 5 hours.When she removed the wrap, she was not burned.The patient stated the area that the wrap was sticking to was kind of painful and her skin was red on (b)(6) 2019.The patient reported admission to the hospital was involved.She described that the skin that had contact with sticky part of wrap was red and painful when wrap was removed.The wrap was difficult to remove without pain, so she pulled it off as quickly as possible.This had not happened with use of any other thermacare product, neck or back.She had never had that problem before.She thought maybe it was too sticky.No therapeutic measures were taken as a result of these events.She also commented she did not like the way the back wrap attaches with stretchy piece across the waist or stomach, not comfortable.Action taken with the suspect product was temporarily withdrawn on an unspecified date in (b)(6) 2019.As of the report on (b)(6) 2020, the patient was still using the wrap as needed.The outcome "not comfortable" was unknown.Clinical outcome of the other events was resolved on an unspecified date.A sample of the product was not available to be returned; product was discarded.The packaging was sealed and intact.Product quality complaint provided the following severity of harm rating of s3 for "skin redness/ pain." additional information has been requested and will be provided as it becomes available.Follow-up 16dec2019: new information received from product quality complaints includes: severity rating (s3) and product information (sample not available to be returned, packaging was sealed and intact).This follow-up upgrades the case to a reportable mdr.Amendment: this follow-up report is being submitted to amend previously reported information: the explanted date was amended to report no date (blank); previously reported with date of (b()6) 2019.Follow-up 07jan2020: new information from a contactable consumer includes: device information (start date, frequency, updated action taken), past device use, new event (discomfort), updated event outcome (recovered), hospitalization seriousness criteria, and additional event details.Company clinical evaluation comment: based on the information provided, the events pain, erythema and device adhesion 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 pain, erythema and device adhesion 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].The area that the wrap was sticking to was kind of painful and red [pain], the area that the wrap was sticking to was kind of painful and red/skin was red/redness [erythema].Maybe it was too sticky [device adhesion issue], not comfortable [discomfort].Narrative: this is a spontaneous report from a contactable consumer.A 71-year-old female patient started to use thermacare heatwrap (thermacare neck, shoulder & wrist) (device lot number ch9468, expiration date jun2022) in (b)(6) 2019 at one wrap placed on neck/shoulder area for 5 hours (1 wrap - 1x/day) for neck pain on left side, near shoulder, for muscle spasm/ spasm in neck.The patient's medical history was reported as none.There were no concomitant medications.The patient used the neck wrap "this week" in the car for 5 hours.When she removed the wrap, she was not burned.The patient stated the area that the wrap was sticking to was kind of painful and her skin was red on (b)(6) 2019.The patient reported admission to the hospital was involved.She described that the skin that had contact with sticky part of wrap was red and painful when wrap was removed.The wrap was difficult to remove without pain, so she pulled it off as quickly as possible.This had not happened with use of any other thermacare product, neck or back.She had never had that problem before.She thought maybe it was too sticky.No therapeutic measures were taken as a result of these events.She also commented she did not like the way the back wrap attaches with stretchy piece across the waist or stomach, not comfortable.Action taken with the suspect product was temporarily withdrawn on an unspecified date in (b)(6) 2019.As of the report on (b)(6) 2020, the patient was still using the wrap as needed.The outcome "not comfortable" was unknown.Clinical outcome of the other events was resolved on an unspecified date.A sample of the product was not available to be returned; product was discarded.The packaging was sealed and intact.Product quality complaint provided the following severity of harm rating of s3 for "skin redness/ pain." product investigation results are as follows: batch ch9468 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 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 (37.6°c - 41.6°c).The material records for nsw/mj skin contact adhesive laminate (sca); material number r000006147 were reviewed.There were four batches of sca used in the manufacturing of the batch, batches 2001134737, 2001134738, 2001134622 and 2001134623.There were no raw material incident forms completed for these batches of sca material.Sca laminate passed all criteria for release for use in manufacturing.This batch has been reviewed from a manufacturing perspective.There are no known site investigations associated with this batch involving wrap temperatures or sca material.The dhr, reserve samples, and trending were evaluated.No quality issues were identified.Conclusion: the root cause category is non assignable (complaint not confirmed).After a review of the skin contact adhesive laminate (sca) material records for the batches of sca used in this batch the root cause of the consumer stating "her skin was red.Reports her skin is still red where the heat wrap was removed," is inconclusive since review of records does not provide evidence to support defective product.Sca laminate passed all criteria for release for use in manufacturing.Our manufacturing operations employ quality control procedures which include in process testing, thermal testing and visual inspection, to ensure the quality of the product being packaged.No quality issues were identified upon this review of the batch device history record, in process attributes and variable quality checks 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.Reasonably suggest device malfunction: no.Severity of harm: n/a.Follow-up (16dec2019): new information received from product quality complaints includes: severity rating (s3) and product information (sample not available to be returned, packaging was sealed and intact).This follow-up upgrades the case to a reportable mdr.Amendment: this follow-up report is being submitted to amend previously reported information: the explanted date was amended to report no date (blank); previously reported with date of 04dec2019.Follow-up (07jan2020): new information from a contactable consumer includes: device information (start date, frequency, updated action taken), past device use, new event (discomfort), updated event outcome (recovered), hospitalization seriousness criteria, and additional event details.Follow-up (06aug2020): new information received from a product quality complaint group includes: product investigation results.Follow-up attempts are completed.No further information is expected., comment: based on the information provided, the events pain, erythema and device adhesion 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.

Manufacturer Narrative

Batch ch9468 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 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 (37.6°c - 41.6°c).The material records for nsw/mj skin contact adhesive laminate (sca); material number r000006147 were reviewed.There were four batches of sca used in the manufacturing of the batch, batches 2001134737, 2001134738, 2001134622 and.2001134623.There were no raw material incident forms completed for these batches of sca material.Sca laminate passed all criteria for release for use in manufacturing.This batch has been reviewed from a manufacturing perspective.There are no known site investigations associated with this batch involving wrap temperatures or sca material.The dhr, reserve samples, and trending were evaluated.No quality issues were identified.Conclusion: the root cause category is non assignable (complaint not confirmed).After a review of the skin contact adhesive laminate (sca) material records for the batches of sca used in this batch the root cause of the consumer stating ¿her skin was red.Reports her skin is still red where the heat wrap was removed,¿ is inconclusive since review of records does not provide evidence to support defective product.Sca laminate passed all criteria for release for use in manufacturing.Our manufacturing operations employ quality control procedures which include in process testing, thermal testing and visual inspection, to ensure the quality of the product being packaged.No quality issues were identified upon this review of the batch device history record, in process attributes and variable quality checks 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.Reasonably suggest device malfunction: no.Severity of harm: n/a.

• Brand Name: THERMACARE NECK, SHOULDER & WRIST
• Type of Device: DISPOSABLE PACK, HOT
• Manufacturer (Section D): PFIZER CONSUMER HEALTH CARE; 1231 wyandotte drive; albany GA 31705
• MDR Report Key: 9511942
• MDR Text Key: 188331532
• Report Number: 1066015-2019-00561
• 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,Followup
• Report Date: 12/09/2019

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: 06/01/2022
• Device Lot Number: CH9468
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/23/2019
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 01/08/2020; 01/23/2020; 08/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 71 YR
• Patient Weight: 61