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

Lot Number W81901

Device Problem Use of Device Problem (1670)

Patient Problems Burn, Thermal (2530); Partial thickness (Second Degree) Burn (2694)

Event Date 12/13/2018

Event Type  Injury  

Event Description

Event verbatim [preferred term] has a burn mark from it and now she has a blister on her leg/the size of a nickel or slightly bigger [burns second degree], thermacare knee & elbow used for pinched nerve in her leg [device use error], thermacare knee & elbow used for pinched nerve in her leg [device use issue].Case narrative: this is a spontaneous report from a contactable consumer (patient's son).A (b)(6) female patient started to receive thermacare heatwrap (thermacare knee & elbow), device lot number w81901, expiration date may 2021, from an unspecified date, for a pinched nerve in her leg.Medical history included she is a diabetic, she lost her voice on an unknown date, and has a degenerative disc.There were no concomitant medications.Past drug history includes using thermacare heatwrap in the past without issues.The patient's son was reporting on behalf of his mom because she lost her voice.He said that he was calling about the thermacare knee and elbow wrap.He reported that she has degenerative disc and a pinched nerve in her leg.On (b)(6) 2018, she put the wrap on her leg and when she took it off, she has a burn mark from it and now she has a blister on her leg and she is a diabetic.He said that the burn is about the size of a nickel or slightly bigger.He reported that she has used them before and they have never burned her.He stated that he thinks that the wrap that burned his mother was the last wrap in the box (3-count box).He said that he thinks that his mother put it on at about 0600 that morning and took it off about 4:30 to 5pm that evening.The action taken with thermacare heat wrap was not reported.He said that she is treating the burn and blister with a and d ointment.The outcome of the blister was not recovered and the remaining 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 blister, device use error and device use issue as described 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 blister, device use error and device use issue as described 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.

Manufacturer Narrative

Investigation summary: the root cause category is non-assignable (complaint not confirmed).After a review of the batch thermal records, thermal results all met product release criteria.Consumer reports his mother used a wrap and "she has a burn mark from it and now she has a blister on her leg and she is a diabetic".The cause of the burn 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.

Event Description

Has a burn mark from it and now she has a blister on her leg/the size of a nickel or slightly bigger [burns second degree] , thermacare knee & elbow used for pinched nerve in her leg [device use issue],.Case narrative: this is a spontaneous report from a contactable consumer (patient's son).A 58-year-old female patient started to receive thermacare heatwrap (thermacare neck, shoulder & wrist), device lot number: w81901, expiration date may2021, from an unspecified date at unknown frequency for a pinched nerve in her leg.Medical history included she was a diabetic, she lost her voice on an unknown date, and had a degenerative disc.There were no concomitant medications.Past product history included thermacare heatwraps (thermacare heatwraps) from an unspecified date for an unknown indication with no adverse effect, without issues.The patient's son was reporting on behalf of his mother because she lost her voice.He said that he was calling about the "thermacare knee and elbow" (as initially reported) wrap.He reported that she had degenerative disc and a pinched nerve in her leg.On (b)(6) 2018, she put the wrap on her leg and when she took it off, she had a burn mark from it and now she had a blister on her leg and she was a diabetic.He said that the burn was about the size of a nickel or slightly bigger.He reported that she had used them before and they had never burned her.He stated that he thought that the wrap that burned his mother was the last wrap in the box (3-count box).He said that his mother put it on at about 0600 that morning and took it off about 4:30 to 5pm that evening.The action taken in response to the events for thermacare heatwrap was unknown.He said that she was treating the burn and blister with a and d ointment.The outcome of the burn blister was not resolved and the outcome of the remaining events was unknown.As of 22feb2019, according to the product quality complaint group: investigation summary: the root cause category is non-assignable (complaint not confirmed).After a review of the batch thermal records, thermal results all met product release criteria.Consumer reports his mother used a wrap and "she has a burn mark from it and now she has a blister on her leg and she is a diabetic".The cause of the burn 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.Follow-up (22feb2019): new information received from the product quality complaint group includes investigational results.Amendment: this follow-up report is being submitted to amend previously reported information: thermacare product updated to thermacare neck, shoulder & wrist per product quality complaint group investigation for device lot number: w81901.Company clinical evaluation comment: based on the information provided, the event of burns second degree as described is considered serious bodily injury 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.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.In the case narrative there is evidence of device use error which most likely contributed to this incident.No remedial action/corrective action/field safety corrective action is suggested at this time., comment: based on the information provided, the event of burns second degree as described is considered serious bodily injury 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.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.In the case narrative there is evidence of 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

Investigation summary: the root cause category is non-assignable (complaint not confirmed).After a review of the batch thermal records, thermal results all met product release criteria.Consumer reports his mother used a wrap and "she has a burn mark from it and now she has a blister on her leg and she is a diabetic".The cause of the burn 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.

Event Description

Event verbatim [preferred term] has a burn mark from it and now she has a blister on her leg/the size of a nickel or slightly bigger [burns second degree] , thermacare knee & elbow used for pinched nerve in her leg [device use issue] ,.Case narrative:this is a spontaneous report from a contactable consumer (patient's son).A (b)(6) female patient started to receive thermacare heatwrap (thermacare knee & elbow), device lot number w81901, expiration date may2021, from an unspecified date at unknown frequency for a pinched nerve in her leg.Medical history included she was a diabetic, she lost her voice on an unknown date, and had a degenerative disc.There were no concomitant medications.Past product history included thermacare heatwraps (thermacare heatwraps) from an unspecified date for an unknown indication with no adverse effect, without issues.The patient's son was reporting on behalf of his mother because she lost her voice.He said that he was calling about the thermacare knee and elbow wrap.He reported that she had degenerative disc and a pinched nerve in her leg.On 13dec2018, she put the wrap on her leg and when she took it off, she had a burn mark from it and now she had a blister on her leg and she was a diabetic.He said that the burn was about the size of a nickel or slightly bigger.He reported that she had used them before and they had never burned her.He stated that he thought that the wrap that burned his mother was the last wrap in the box (3-count box).He said that his mother put it on at about 0600 that morning and took it off about 4:30 to 5pm that evening.The action taken in response to the events for thermacare heatwrap was unknown.He said that she was treating the burn and blister with a and d ointment.The outcome of the burn blister was not resolved and the outcome of the remaining events was unknown.As of 22feb2019, according to the product quality complaint group: investigation summary: the root cause category is non-assignable (complaint not confirmed).After a review of the batch thermal records, thermal results all met product release criteria.Consumer reports his mother used a wrap and "she has a burn mark from it and now she has a blister on her leg and she is a diabetic".The cause of the burn 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.Follow-up (22feb2019): new information received from the product quality complaint group includes investigational results.Company clinical evaluation comment: based on the information provided, the events of burn blister, device use error and device use issue as described 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.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.In the case narrative there is evidence of device use error which most likely contributed to this incident.No remedial action/corrective action/field safety corrective action is suggested at this time., comment: based on the information provided, the event of burn blister as described are considered serious bodily injury 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.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.In the case narrative there is evidence of 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

Investigation summary: the root cause category is non-assignable (complaint not confirmed).After a review of the batch thermal records, thermal results all met product release criteria.Consumer reports his mother used a wrap and "she has a burn mark from it and now she has a blister on her leg and she is a diabetic".The cause of the burn 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.

Event Description

Event verbatim [preferred term] has a burn mark from it and now she has a blister on her leg/the size of a nickel or slightly bigger [burns second degree] , thermacare knee & elbow used for pinched nerve in her leg [device use issue].Case narrative:this is a spontaneous report from a contactable consumer (patient's son).A 58-year-old female patient started to receive thermacare heatwrap (thermacare knee & elbow), device lot number w81901, expiration date may2021, from an unspecified date at unknown frequency for a pinched nerve in her leg.Medical history included she was a diabetic, she lost her voice on an unknown date, and had a degenerative disc.There were no concomitant medications.Past product history included thermacare heatwraps (thermacare heatwraps) from an unspecified date for an unknown indication with no adverse effect, without issues.The patient's son was reporting on behalf of his mother because she lost her voice.He said that he was calling about the thermacare knee and elbow wrap.He reported that she had degenerative disc and a pinched nerve in her leg.On (b)(6) 2018, she put the wrap on her leg and when she took it off, she had a burn mark from it and now she had a blister on her leg and she was a diabetic.He said that the burn was about the size of a nickel or slightly bigger.He reported that she had used them before and they had never burned her.He stated that he thought that the wrap that burned his mother was the last wrap in the box (3-count box).He said that his mother put it on at about 0600 that morning and took it off about 4:30 to 5pm that evening.The action taken in response to the events for thermacare heatwrap was unknown.He said that she was treating the burn and blister with a and d ointment.The outcome of the burn blister was not resolved and the outcome of the remaining events was unknown.As of 22feb2019, according to the product quality complaint group: investigation summary: the root cause category is non-assignable (complaint not confirmed).After a review of the batch thermal records, thermal results all met product release criteria.Consumer reports his mother used a wrap and "she has a burn mark from it and now she has a blister on her leg and she is a diabetic".The cause of the burn 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.Follow-up (22feb2019): new information received from the product quality complaint group includes investigational results.Amendment: this follow-up report is being submitted to amend previously reported information: case comment amended.Company clinical evaluation comment: based on the information provided, the event of burns second degree as described is considered serious bodily injury 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.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.In the case narrative there is evidence of device use error which most likely contributed to this incident.No remedial action/corrective action/field safety corrective action is suggested at this time., comment: based on the information provided, the event of burns second degree as described is considered serious bodily injury 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.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.In the case narrative there is evidence of device use error which most likely contributed to this incident.No remedial action/corrective action/field safety corrective action is suggested at this time.

• 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: 8197506
• MDR Text Key: 131482879
• Report Number: 1066015-2018-00210
• 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: 12/14/2018

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?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/01/2021
• Device Lot Number: W81901
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/26/2018
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 03/04/2019; 03/05/2019; 03/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 58 YR