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

Lot Number S41948

Device Problem Use of Device Problem (1670)

Patient Problems Itching Sensation (1943); Pain (1994); Tingling (2171); Partial thickness (Second Degree) Burn (2694)

Event Date 12/18/2017

Event Type  Injury  

Event Description

Event verbatim [preferred term] felt a burning or tingling sensation, 10 hours after she removed the wrap discovered a blister with itching, painful and throbbing [burns second degree] , did not check the skin under the device during use, had read the usage instructions prior to use [intentional device misuse] , thought it was a bad heatwrap where one of the cells of the heatwrap cell sites might have been the issue [device 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 and wrist) (device lot number s41948, expiration date apr2020) from an unspecified date in (b)(6) 2017 at one heatwrap applied for shoulder pain following an injury at work.The patient's medical history included an injury at work on an unspecified date in (b)(6) 2017 and ongoing.The patient was not pregnant and was not post-menopausal.There were no concomitant medications.Past product history included thermacare heatwraps (thermacare heatwraps) from an unspecified date for an unspecified indication with no adverse effect.On (b)(6) 2017, the patient reported she attached the heatwrap to her body using the adhesive and wore the heatwrap for less than 2 hours, as she usually does, and initially felt a burning or tingling sensation.She stated about 10 hours after she had removed the heatwrap, she experienced a blister with itching right in the bra area.The blister was painful and throbbing.The patient reported she scratched the area and popped the blister.The blister kept getting scraped by her bra and she was concerned she might scar related to this.The patient thought it was a bad heatwrap where one of the cells of the heatwrap cell sites might have been the issue.The patient did not consult a healthcare professional as a result of the events.She stated she would be going to see a dermatologist as she was concerned she might scar.The patient had the other two unused heatwraps but had discarded the one involved with the adverse events.The heatwrap package was sealed and no damage was noticed.The patient assessed her skin tone as very light or fair.She denied having sensitive skin or any abnormal skin conditions.The patient is currently under the care of a physician for shoulder pain following an injury at work.The doctor had recommended thermacare heatwraps for her shoulder pain.The patient had not previously used other heat products for pain relief.She did not engage in exercise while using the heatwrap and was not taking any other medications (including over-the-counter, herbal, nutritional or any applied to the skin) during the time the events were experienced.The patient had read the usage instructions prior to using the heatwrap.She denied checking her skin under the heatwrap during use.Action taken with the suspect product was temporarily discontinued on (b)(6) 2017.She stated she had planned to use the product again in the future.Clinical outcome of the event burn blister was not resolved.Clinical outcome of the event itching was resolved on (b)(6) 2017.Clinical outcome of 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 misuse' 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 'burn blister', 'device misuse' 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] felt a burning or tingling sensation, 10 hours after she removed the wrap discovered a blister with itching, painful and throbbing [burns second degree] , did not check the skin under the device during use, had read the usage instructions prior to use [intentional device misuse] , thought it was a bad heatwrap where one of the cells of the heatwrap cell sites might have been the issue [device issue].Case narrative:this is a spontaneous report from a contactable consumer or other non hcp.A (b)(6) year-old latina female patient started to use thermacare heatwrap (thermacare neck, shoulder & wrist) (device lot number s41948, expiration date apr2020) from an unspecified date in (b)(6) 2017 at one heatwrap applied for shoulder pain following an injury at work.The patient's medical history included an injury at work on an unspecified date in (b)(6) 2017 and ongoing.The patient was not pregnant and was not post-menopausal.There were no concomitant medications.Past product history included thermacare heatwraps (thermacare heatwraps) from an unspecified date for an unspecified indication with no adverse effect.On (b)(6) 2017, the patient reported she attached the heatwrap to her body using the adhesive and wore the heatwrap for less than 2 hours, as she usually does, and initially felt a burning or tingling sensation.She stated about 10 hours after she had removed the heatwrap, she experienced a blister with itching right in the bra area.The blister was painful and throbbing.The patient reported she scratched the area and popped the blister.The blister kept getting scraped by her bra and she was concerned she might scar related to this.The patient thought it was a bad heatwrap where one of the cells of the heatwrap cell sites might have been the issue.The patient did not consult a healthcare professional as a result of the events.She stated she would be going to see a dermatologist as she was concerned she might scar.The patient had the other two unused heatwraps but had discarded the one involved with the adverse events.The heatwrap package was sealed and no damage was noticed.The patient assessed her skin tone as very light or fair.She denied having sensitive skin or any abnormal skin conditions.The patient is currently under the care of a physician for shoulder pain following an injury at work.The doctor had recommended thermacare heatwraps for her shoulder pain.The patient had not previously used other heat products for pain relief.She did not engage in exercise while using the heatwrap and was not taking any other medications (including over-the-counter, herbal, nutritional or any applied to the skin) during the time the events were experienced.The patient had read the usage instructions prior to using the heatwrap.She denied checking her skin under the heatwrap during use.Action taken with the suspect product was temporarily discontinued on (b)(6) 2017.She stated she had planned to use the product again in the future.Clinical outcome of the event burn blister was not resolved.Clinical outcome of the event itching was resolved on (b)(6) 2017.Clinical outcome of remaining events was unknown.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 states she "experienced a blister" after using a wrap.The cause of the "blister" is inconclusive since review of records does not provide evidence to support 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, 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.Additional information has been requested and will be provided as it becomes available.Follow-up (01feb2018): new information received from product quality complaint group includes investigation results.Company clinical evaluation comment: based on the information provided, the events of 'burn blister', 'device misuse' 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.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.No remedial action/corrective action/field safety corrective action is suggested at this time., comment: based on the information provided, the events of 'burn blister', 'device misuse' 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.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.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 states she "experienced a blister" after using a wrap.The cause of the "blister" is inconclusive since review of records does not provide evidence to support 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, 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.

• 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: 7163540
• MDR Text Key: 96339814
• Report Number: 1066015-2018-00002
• 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: 12/28/2017

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: 04/01/2020
• Device Lot Number: S41948
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/04/2018
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/07/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 42 YR
• Patient Weight: 65