MAUDE Adverse Event Report: PFIZER CONSUMER HEALTH CARE THERMACARE HEATWRAP; DISPOSABLE PACK, HOT

Device Problem Temperature Problem (3022)

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

Event Date 03/19/2016

Event Type  Injury  

Event Description

Burned, burn blisters [burns second degree].Did not check the skin while wearing thermacare [intentional device misuse].Case description: this is a spontaneous report from pfizer sponsored program (b)(6) received from a contactable consumer via medical information.The consumer reported for her mother in law.A female patient of an unspecified age and ethnicity started to receive thermacare heatwrap (thermacare heatwrap), on the neck on (b)(6) 2016 for first time for osteoarthritis and pain in the neck.The patient medical history included osteoarthritis unknown if ongoing.The patient's concomitant medications were none.The patient had previously electric heating pad on different days for 3 hours.The patient used thermacare in the neck, after two hours (initial reported applied for 5 hours) the patient felt heat and the product was removed, had unfortunately been burned, there was two burn blisters in the neck.The skin was quite undamaged before use.She did not check the skin while wearing thermacare.Events were occurred on (b)(6) 2016.The patient classifies her skin tone as medium.She has no sensitive skin, and no abnormal skin condition.The thermacare adhesive was attached to the body.The patient was not in exercising while using thermacare.The usage instruction on thermacare was read before using the product.The patient had been in contact with a healthcare professional.The action taken in response to the event for thermacare heatwrap was discontinued on (b)(6) 2016.The blisters lasted for approximately one week, and was recovered on (b)(6) 2016, the other event was resolved on (b)(6) 2016.The event occurred in a country different from that of the reporter.This may be a duplicate report if another reporter from the country where the event occurred has submitted the same information to his/her local agency.Additional information has been requested and will be provided as it becomes available.Follow-up (13apr2016) new information received from the contactable consumer included.Indication, product start ate, stop date, event onset date, past product history, no concomitant medication.New event burn blisters in the neck and did not check the skin while wearing thermacare reported, case been upgrade to serious.Company clinical evaluation comment based on the information provided, the events burn blister and intentional device misuse as described in this case are considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure, assessed as associated with the use of the device.This case meets initial 10-day eu and 30-day fda reportability.Case comment: based on the information provided, the events burn blister and intentional device misuse as described in this case are considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure, assessed as associated with the use of the device.This case meets initial 10-day eu and 30-day fda reportability.

Event Description

Case description: this is a spontaneous report from (b)(6) program, (b)(6).A contactable consumer reported on behalf of her mother-in-law.This female patient of an unspecified age and ethnicity started to use thermacare heatwrap (thermacare heatwrap) on the neck on (b)(6) 2016 for first time for osteoarthritis and pain in the neck.The patient's medical history was not reported.Concomitant medications were reported as none.The patient had previously used an electric heating pad on different days for 3 hours.On (b)(6) 2016, the patient used thermacare on the neck and after two hours (initially reported she applied for 5 hours) the patient felt heat and had unfortunately been burned.There were 2 burn blisters on the neck.The skin was quite undamaged before use.The patient removed the heatwrap.She stated she did not check the skin while wearing thermacare.The patient assessed her skin tone as medium.She denied having sensitive skin, and had no abnormal skin conditions.The thermacare adhesive was attached to the body.The patient was not in exercising while using the heatwraps and had read the usage instructions prior to using the product.The patient had been in contact with a healthcare professional.Action taken in response to the event for thermacare heatwrap was discontinued on (b)(6) 2016.The blisters lasted for approximately one week, and resolved on (b)(6) 2016.The other event resolved on (b)(6) 2016.The event occurred in a country different from that of the reporter.This may be a duplicate report if another reporter from the country where the event occurred has submitted the same information to his/her local agency.Additional information has been requested and will be provided as it becomes available.Follow-up (13apr2016) new information received from the contactable consumer included.Indication, product start date, stop date, event onset date, past product history, no concomitant medication.New event burn blisters in the neck and did not check the skin while wearing thermacare reported, case been upgrade to serious.Follow-up (25apr2016): new information received from contactable consumer includes: country of incidence updated as the adverse event occurred in (b)(6).Follow-up attempts completed.No further information expected.Company clinical evaluation comment based on the information provided, the events burn blister and intentional device misuse as described in this case are considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure, assessed as associated with the use of the device.This case meets final 10-day eu and 30-day fda reportability.Case comment: based on the information provided, the events burn blister and intentional device misuse as described in this case are considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure, assessed as associated with the use of the device.This case meets final 10-day eu and 30-day fda reportability.

Event Description

Case description: this is a spontaneous report from pfizer-sponsored program, webadmin-dk@pfizer.Com.A contactable consumer reported on behalf of her mother-in-law.This female patient of an unspecified age and ethnicity started to use thermacare heatwrap (thermacare heatwrap) (no lot number available) on the neck on (b)(6) 2016 for first time for osteoarthritis and pain in the neck.The patient's medical history was not reported.Concomitant medications were reported as none.The patient had previously used an electric heating pad on different days for 3 hours.On (b)(6) 2016, the patient used thermacare on the neck and after two hours (initially reported she applied for 5 hours) the patient felt heat and had unfortunately been burned.There were 2 burn blisters on the neck.The skin was quite undamaged before use.The patient removed the heatwrap.She stated she did not check the skin while wearing thermacare.The patient assessed her skin tone as medium.She denied having sensitive skin, and had no abnormal skin conditions.The thermacare adhesive was attached to the body.The patient was not in exercising while using the heatwraps and had read the usage instructions prior to using the product.The patient had been in contact with a healthcare professional.Action taken in response to the event for thermacare heatwrap was permanently discontinued on (b)(6) 2016.The blisters lasted for approximately one week, and resolved on (b)(6) 2016.The other event resolved on (b)(6) 2016.The event occurred in a country different from that of the reporter.This may be a duplicate report if another reporter from the country where the event occurred has submitted the same information to his/her local agency.Additional information has been requested and will be provided as it becomes available.Follow-up (13apr2016) new information received from the contactable consumer included.Indication, product start date, stop date, event onset date, past product history, no concomitant medication.New event burn blisters in the neck and did not check the skin while wearing thermacare reported, case been upgrade to serious.Follow-up (25apr2016): new information received from contactable consumer includes: country of incidence updated as the adverse event occurred in (b)(6).Follow-up (17jun2016): this follow-up is being submitted to notify that an investigation of the device was unable to be conducted.Follow-up attempts have been completed and no further information is expected.Company clinical evaluation comment based on the information provided, the events burn blister and intentional device misuse as described in this case are considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure, assessed as associated with the use of the device.This case meets final (b)(6) and 30-day fda reportability.Evaluation summary: results of manufactures final investigation (final report) was not completed as the reporter did not provide a lot number; therefore, an investigation could not be performed.All follow-up attempts were completed and no further information expected.

Manufacturer Narrative

Conclusion: the root cause category is non-assignable (complaint not confirmed as a quality defect).There was limited device specific information provided, no batch number or return sample was available for evaluation.Without a batch reference number and/or return sample a manufacturing and technical evaluation cannot be completed for the wrap involved in this case.There is not a product quality related trend identified for the subclass adverse event safety request for investigation.The 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.

Event Description

Event verbatim [preferred term] burned, burn blisters [burns second degree] , did not check the skin while wearing thermacare [intentional device misuse] ,.Case narrative:this is a spontaneous report from pfizer-sponsored program, webadmin-dk@pfizer.Com.A contactable consumer reported on behalf of her mother-in-law.This 83-year-old female patient of an unspecified ethnicity started to use thermacare heatwrap (thermacare heatwrap) (no lot number available) on the neck on (b)(6)2016 for first time for osteoarthritis and pain in the neck.The patient's medical history was not reported.Concomitant medications were reported as none.The patient had previously used an electric heating pad on different days for 3 hours.On (b)(6)2016, the patient used thermacare on the neck and after two hours (initially reported she applied for 5 hours) the patient felt heat and had unfortunately been burned.There were 2 burn blisters on the neck.The skin was quite undamaged before use.The patient removed the heatwrap.She stated she did not check the skin while wearing thermacare.The patient assessed her skin tone as medium.She denied having sensitive skin, and had no abnormal skin conditions.The thermacare adhesive was attached to the body.The patient was not in exercising while using the heatwraps and had read the usage instructions prior to using the product.The patient had been in contact with a healthcare professional.Action taken in response to the event for thermacare heatwrap was permanently discontinued on (b)(6)2016.The blisters lasted for approximately one week, and resolved on (b)(6)2016.The other event resolved on (b)(6)2016.Product investigation results were as follows: conclusion: the root cause category is non-assignable (complaint not confirmed as a quality defect).There was limited device specific information provided, no batch number or return sample was available for evaluation.Without a batch reference number and/or return sample a manufacturing and technical evaluation cannot be completed for the wrap involved in this case.There is not a product quality related trend identified for the subclass adverse event safety request for investigation.The 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.The event occurred in a country different from that of the reporter.This may be a duplicate report if another reporter from the country where the event occurred has submitted the same information to his/her local agency.Follow-up (13apr2016) new information received from the contactable consumer included.Indication, product start date, stop date, event onset date, past product history, no concomitant medication.New event burn blisters in the neck and did not check the skin while wearing thermacare reported, case been upgrade to serious.Follow-up (25apr2016): new information received from contactable consumer includes: country of incidence updated as the adverse event occurred in denmark.Follow-up (17jun2016): this follow-up is being submitted to notify that an investigation of the device was unable to be conducted.Follow-up attempts have been completed and no further information is expected.Follow-up (12feb2020): new information received from albany site includes product investigation summary.No follow-up attempts are needed.No further information is expected., comment: based on the information provided, the events burn blister and intentional device misuse as described in this case are considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure, assessed as associated with the use of the device.There was limited device specific information provided, no batch number or return sample was available for evaluation.Without a batch reference number and/or return sample a manufacturing and technical evaluation cannot be completed for the wrap involved in this case.There is not a product quality related trend identified for the subclass adverse event safety request for investigation.There is not a complaint trend for any class(es) associated to the suggested key product complaints database terms.No further investigations or actions are suggested at this time.

• Brand Name: THERMACARE HEATWRAP
• Type of Device: DISPOSABLE PACK, HOT
• Manufacturer (Section D): PFIZER CONSUMER HEALTH CARE; 1231 wyandotte drive; albany GA 31705
• MDR Report Key: 5607987
• MDR Text Key: 43641536
• Report Number: 1066015-2016-00073
• 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
• Report Date: 03/25/2016

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
• Initial Date Manufacturer Received: 04/13/2016
• Initial Date FDA Received: 04/26/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided; 06/17/2016
• Supplement Dates FDA Received: 05/09/2016; 06/24/2016; 02/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 83 YR
• Patient Weight: 65