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

Catalog Number 0 62107 33640 6

Device Problems Use of Device Problem (1670); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Burn, Thermal (2530)

Event Date 12/10/2019

Event Type  Injury  

Event Description

Severe burns [thermal burn].Case narrative:this is a spontaneous report from a contactable consumer.A female patient of an unspecified age started to receive thermacare heatwrap (robax neck & shoulder heatwrap), device lot number aw8655, expiration date mar2020, on (b)(6) 2019, for an unspecified indication.Medical history and concomitant medications were not reported.On (b)(6) 2019, the patient experienced severe burns from using thermacare heatwrap.She stated that the burns are bad and are being treated.She still has the product.The action taken with thermacare heatwrap was permanently withdrawn.The outcome of the event was not recovered.Additional information has been requested and will be provided as it becomes available.Company clinical evaluation comment: the reported event severe burns was assessed as associated with the use of thermacare heatwrap.However, human error while administering thermacare heatwrap (robax neck & shoulder heatwrap), can not be excluded.This case will be reassessed should additional information become available.Comment: the reported event severe burns was assessed as associated with the use of thermacare heatwrap.However, human error while administering thermacare heatwrap (robax neck & shoulder heatwrap), can not be excluded.This case will be reassessed should additional information become available.

Event Description

Event verbatim [preferred term] severe burns [thermal burn] , did not check her skin under it.[intentional device misuse] ,.Case narrative:this is a spontaneous report from a contactable consumer (patient's daughter).A 93 year-old female patient started to receive thermacare heatwrap (robax neck & shoulder heatwrap), in a red box, device lot number aw8655, expiration date mar2020, catalog number 0 62107 33640 6, on (b)(6) 2019, for a sore shoulder.Medical history includes osteo.The patient classified her skin tone as medium (neither light nor dark), she does not have sensitive skin nor any abnormal skin conditions.Concomitant medications were not reported.The patient had used thermacare before and stated that it did not burn like this at all, just slight red.She has used other heat products in the past for pain relief without a problem.On (b)(6) 2019, the patient experienced severe burns from using a thermacare heatwrap.She was hospitalized on an unspecified date.She stated that the burns are bad and are being treated, putting triple anitibiotic polysporin and fresh gauze tape every second day.She has a large scab which is still painful.She reported that she used the heatwrap for a few hours one day for about 1/2 day.She applied the heatwrap adhesive to her body and was wearing a blouse.She was not exercising while wearing the heatwrap and did not check her skin under it.The patient reported that she read the usage instructions, saying the printing was small.She was not taking any medication during the time she used the heatwrap.She still has the product.The action taken with thermacare heatwrap was permanently withdrawn.The outcome of the events was not recovered.According to product quality complaint group: severity of harm was s3.Follow-up (26dec2019): new information received from product quality complaint group included: severity of harm.Follow-up (02jan2020): new information received from the same contactable patient and the patient's daughter includes: demographic data (age, dob added); medical history; suspect device data (indication added, expiration date updated); and event data (large scab, painful, slight red added with hospitalization criteria).Company clinical evaluation comment: based on the information provided, the events of "burn" requiring hospitalization and event intentional device misuse are considered serious bodily injury 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 "burn" requiring hospitalization and event intentional device misuse are considered serious bodily injury 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] severe burns [thermal burn] ,.Case narrative:this is a spontaneous report from a contactable consumer.A female patient of an unspecified age started to receive thermacare heatwrap (robax neck & shoulder heatwrap), device lot number aw8655, expiration date mar2020, catalog number 0 62107 33640 6, on (b)(6)2019, for an unspecified indication.Medical history and concomitant medications were not reported.On (b)(6)2019, the patient experienced severe burns from using thermacare heatwrap.She stated that the burns are bad and are being treated.She still has the product.The action taken with thermacare heatwrap was permanently withdrawn.The outcome of the event was not recovered.According to product quality complaint group: severity of harm was s3.Additional information has been requested and will be provided as it becomes available.Follow-up (26dec2019): new information received from product quality complaint group included: severity of harm.Company clinical evaluation comment: based on the information provided, the event of "burn" as described are considered serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure.The event is medically assessed as associated with the use of the device., comment: based on the information provided, the event of "burn" as described are considered serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure.The event is medically assessed as associated with the use of the device.

Event Description

Severe burns [thermal burn], did not check her skin under it.[intentional device misuse].Case narrative: this is a spontaneous report from a contactable consumer (patient's daughter).A 93 year-old female patient started to receive thermacare heatwrap (robax neck & shoulder heatwrap), in a red box, device lot number aw8655, expiration date mar2020, catalog number 0 62107 33640 6, on (b)(6) 2019, for a sore shoulder.Medical history includes osteo.The patient classified her skin tone as medium (neither light nor dark), she does not have sensitive skin nor any abnormal skin conditions.Concomitant medications were not reported.The patient had used thermacare before and stated that it did not burn like this at all, just slight red.She has used other heat products in the past for pain relief without a problem.On (b)(6) 2019, the patient experienced severe burns from using a thermacare heatwrap.She was hospitalized on an unspecified date.She stated that the burns are bad and are being treated, putting triple anitibiotic polysporin and fresh gauze tape every second day.She has a large scab which is still painful.She reported that she used the heatwrap for a few hours one day for about 1/2 day.She applied the heatwrap adhesive to her body and was wearing a blouse.She was not exercising while wearing the heatwrap and did not check her skin under it.The patient reported that she read the usage instructions, saying the printing was small.She was not taking any medication during the time she used the heatwrap.She still has the product.The action taken with thermacare heatwrap was permanently withdrawn.The outcome of the events was not recovered.According to product quality complaint group: severity of harm was s3.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, "severe burns." the cause of the wrap causing severe burns 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.A visual inspection of one retain sample shows no obvious defects.Retain sample was performed on 06jan2020.Follow-up (26dec2019): new information received from product quality complaint group included: severity of harm.Follow-up (02jan2020): new information received from the same contactable patient and the patient's daughter includes: demographic data (age, dob added); medical history; suspect device data (indication added, expiration date updated); and event data (large scab, painful, slight red added with hospitalization criteria).Follow-up (09jan2020): new information received from product quality complaint group included: investigation summary., comment: based on the information provided, the events of "burn" requiring hospitalization and event intentional device misuse are considered serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure.A causal relationship between the device and the events cannot be ruled out.The review of the lot/batch records does not suggest a defect or quality issue related to the manufacture of this lot.No device malfunction has been identified.There is not a complaint trend for any class(es) associated to the suggested key product complaints database terms.No further investigations or actions is suggested at this time.

Manufacturer Narrative

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, "severe burns." the cause of the wrap causing severe burns 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.A visual inspection of one retain sample shows no obvious defects.Retain sample was performed on 06jan2020.

Manufacturer Narrative

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, "severe burns." the cause of the wrap causing severe burns 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.A visual inspection of one retain sample shows no obvious defects.Retain sample was performed on (b)(6) 2020.

Event Description

Event verbatim [preferred term] severe burns [thermal burn] , did not check her skin under it.[intentional device misuse].Case narrative:this is a spontaneous report from a contactable consumer (patient's daughter).A 93-year-old female patient started to receive thermacare heatwrap (robax neck & shoulder heatwrap), in a red box, device lot number aw8655, expiration date mar2022, catalog number 0 62107 33640 6, on (b)(6) 2019, for a sore shoulder.Medical history included ongoing osteo.The patient classified her skin tone as medium (neither light nor dark), she did not have sensitive skin nor any abnormal skin conditions.Concomitant medications were none.The patient had used thermacare before and stated that it did not burn like this at all, just slight red.She had used other heat products in the past for pain relief without a problem.On (b)(6) 2019, the patient experienced severe burns from using a thermacare heatwrap.She was hospitalized on an unspecified date.She stated that the burns were bad and were being treated, putting triple antibiotic polysporin and fresh gauze tape every second day.She had a large scab which was still painful.She reported that she used the heatwrap for a few hours one day for about 1/2 day.She applied the heatwrap adhesive to her body and was wearing a blouse.She was not exercising while wearing the heatwrap and did not check her skin under it.The patient reported that she read the usage instructions, saying the printing was small.She was not taking any medication during the time she used the heatwrap.She still had the product.The action taken with thermacare heatwrap was permanently withdrawn.The outcome of the events was not recovered.According to product quality complaint group: severity of harm was s3.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, "severe burns." the cause of the wrap causing severe burns 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.A visual inspection of one retain sample shows no obvious defects.Retain sample was performed on (b)(6) 2020.Follow-up (26dec2019): new information received from product quality complaint group included: severity of harm.Follow-up (02jan2020): new information received from the same contactable patient and the patient's daughter includes: demographic data (age added); medical history; suspect device data (indication added, expiration date updated); and event data (large scab, painful, slight red added with hospitalization criteria).Follow-up (09jan2020): new information received from product quality complaint group included: investigation summary.Amendment: this follow-up report is being submitted to amend previously reported information: narrative updated.Follow-up attempts are completed.No further information is expected., comment: based on the information provided, the events of "burn" requiring hospitalization and event intentional device misuse are considered serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure.A causal relationship between the device and the events cannot be ruled out.The review of the lot/batch records does not suggest a defect or quality issue related to the manufacture of this lot.No device malfunction has been identified.There is not a complaint trend for any class(es) associated to the suggested key product complaints database terms.No further investigations or actions is suggested at this time.

Manufacturer Narrative

Batch aw8655 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.The device history record(dhr), reserved samples, and trending were evaluated.No quality issues were identified.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, "severe burns." the cause of the wrap causing severe burns 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.Lot trend assessment and rationale: an evaluation of the complaint confirms that this is the first complaint for the sub class adverse event/serious/unknown received at the albany site requiring an evaluation for this batch.Per sop-105746, complaint trending guideline, 24feb2020, a visual examination was performed to identify a potential trend for the lot and subclass.On the basis of this evaluation, a trend does not exist for this lot.Expedite trend assessment and rationale: an evaluation was made by searching for possible trend for this subclass.Based on this complaint intake, triage, and investigation (citi) search, there is not a trend identified for the subclass of adverse event/serious/unknown.Refer to the 36 month trend chart attachment for nsw8hr ae serious unknown 16dec2016 to 16dec2019.This investigation was reopened on 07oct2020 to change information in the lot trend assessment & rationale and expedite trend assessment & rationale sections.This change was due to a deviation found from sop-105746, complaint trending guidelines, effective dates 19nov2019 and 24feb2020.A notification of nonconformance was opened (b)(4).This deviation will not change the conclusion of the investigation.

Event Description

Event verbatim [preferred term], did not check her skin under it.[intentional device misuse], severe burns [thermal burn], , narrative: this is a spontaneous report from a contactable consumer (patient's daughter).A 93-year-old female patient started to receive thermacare heatwrap (robax neck & shoulder heatwrap), in a red box, device lot number aw8655, expiration date mar2022, catalog number 0 62107 33640 6, on (b)(6) 2019, for a sore shoulder.Medical history included ongoing osteo.The patient classified her skin tone as medium (neither light nor dark), she did not have sensitive skin nor any abnormal skin conditions.Concomitant medications were none.The patient had used thermacare heatwraps before and stated that it did not burn like this at all, just slight red.She had used other heat products in the past for pain relief without a problem.On (b)(6) 2019, the patient experienced severe burns from using a thermacare heatwrap.She was hospitalized on an unspecified date.She stated that the burns were bad and were being treated, putting triple anitibiotic polysporin and fresh gauze tape every second day.She had a large scab which was still painful.She reported that she used the heatwrap for a few hours one day for about 1/2 day.She applied the heatwrap adhesive to her body and was wearing a blouse.She was not exercising while wearing the heatwrap and did not check her skin under it.The patient reported that she read the usage instructions, saying the printing was small.She was not taking any medication during the time she used the heatwrap.She still had the product.The action taken with thermacare heatwrap was permanently withdrawn.The outcome of the events was not recovered.According to product quality complaint group: severity of harm was s3.Batch aw8655 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.The device history record(dhr), reserved samples, and trending were evaluated.No quality issues were identified.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, "severe burns." the cause of the wrap causing severe burns 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.Lot trend assessment and rationale: an evaluation of the complaint confirms that this is the first complaint for the sub class adverse event/serious/unknown received at the albany site requiring an evaluation for this batch.Per sop-105746, complaint trending guideline, 24feb2020, a visual examination was performed to identify a potential trend for the lot and subclass.On the basis of this evaluation, a trend does not exist for this lot.Expedite trend assessment and rationale: an evaluation was made by searching for possible trend for this subclass.Based on this complaint intake, triage, and investigation (citi) search, there is not a trend identified for the subclass of adverse event/serious/unknown.Refer to the 36 month trend chart attachment for nsw8hr ae serious unknown 16dec2016 to 16dec2019.This investigation was reopened on 07oct2020 to change information in the lot trend assessment & rationale and expedite trend assessment & rationale sections.This change was due to a deviation found from sop-105746, complaint trending guidelines, effective dates 19nov2019 and 24feb2020.A notification of nonconformance was opened (b)(4).This deviation will not change the conclusion of the investigation.Follow-up (26dec2019): new information received from product quality complaint group included: severity of harm.Follow-up (02jan2020): new information received from the same contactable patient and the patient's daughter includes: demographic data (age added); medical history; suspect device data (indication added, expiration date updated); and event data (large scab, painful, slight red added with hospitalization criteria).Follow-up (09jan2020): new information received from product quality complaint group included: investigation summary.Amendment: this follow-up report is being submitted to amend previously reported information: narrative updated.Follow-up attempts are completed.No further information is expected.Follow-up (08oct2020): new information received from product quality complaint group included: updated trend information.No follow-up attempts are needed.No further information is expected., comment: based on the information provided, the events of "burn" requiring hospitalization and event intentional device misuse are considered serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure.A causal relationship between the device and the events cannot be ruled out.The review of the lot/batch records does not suggest a defect or quality issue related to the manufacture of this lot.No device malfunction has been identified.There is not a complaint trend for any class(es) associated to the suggested key product complaints database terms.No further investigations or actions is suggested at this time.

• Brand Name: ROBAX NECK & SHOULDER HEATWRAP
• Type of Device: DISPOSABLE PACK, HOT
• Manufacturer (Section D): PFIZER CONSUMER HEALTH CARE; 1231 wyandotte drive; albany GA 31705
• MDR Report Key: 9519737
• MDR Text Key: 188813889
• Report Number: 1066015-2019-00558
• 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,Followup,Followup
• Report Date: 12/16/2019

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: 03/01/2022
• Device Catalogue Number: 0 62107 33640 6
• Device Lot Number: AW8655
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/26/2019
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 01/08/2020; 01/10/2020; 01/24/2020; 03/25/2020; 10/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 93 YR
• Patient Weight: 85