MAUDE Adverse Event Report: PFIZER CONSUMER HEALTH CARE THERMACARE LOWER BACK & HIP; DISPOSABLE PACK, HOT

Device Problems Improper or Incorrect Procedure or Method (2017); Patient-Device Incompatibility (2682)

Patient Problems Hypersensitivity/Allergic reaction (1907); Pain (1994); Scarring (2061); Reaction (2414)

Event Date 01/01/2017

Event Type  Injury  

Event Description

Skin reaction (wound with formation of crusts), allergic reaction [hypersensitivity], skin reaction (wound with formation of crusts) [skin wound], skin reaction (wound with formation of crusts) [scab], scar [scar], used thermacare lower back & hip for cervical and thoracic/ continued to take thermacare for cervical spine [intentional device use issue].Case narrative: this is a spontaneous report from a pfizer-sponsored program, brand websites for devision consumer healthcare (b)(4).A (b)(6)-year-old female patient, started to receive thermacare heatwrap (thermacare lower back & hip), via an unspecified route of administration from an unspecified date since years at an unspecified dose as needed for chronic back pain.The patient medical history was not reported.No concomitant medication administered.The patient stated on (b)(6) 2017 she used thermacare for back pain (cervical and thoracic) and she experienced a skin reaction (wound with formation of crusts) after 5 min of using the heat wrap.The consumer removed the thermacare immediately due to this allergic reaction.As treatment for the events "skin reaction (wound with formation of crusts), allergic reaction" she used a cortisone ointment.No hospitalization needed.Patient continued to use thermacare as needed but "as gel or for cervical spine not more than point patch." the outcome of the events "skin reaction (wound with formation of crusts), allergic reaction" was resolved with sequel (scar) and for the event "scar" and "used thermacare lower back & hip for cervical and thoracic/ continued to take thermacare for cervical spine" was unknown.Additional information has been requested and will be provided as it becomes available.Follow-up (12feb2017): new information received from the contactable consumer includes: patient age, product dosage frequency, onset date and outcome for initial events "skin reaction (wound with formation of crusts), allergic reaction" and new events "scar" and "used thermacare lower back & hip for cervical and thoracic/ continued to take thermacare for cervical spine".Follow-up attempts completed.No further information expected.Follow-up (13jan2017): this follow-up report is being submitted to upgrade this case to a reportable mdr.Company clinical evaluation comment: based on the information provided, the events hypersensitivity, skin wound, scab and scar as described are considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.The event intentional device use issue is non-serious.The events are medically assessed as associated with the use of the device.Comment: based on the information provided, the events hypersensitivity, skin wound, scab and scar as described are considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.The event intentional device use issue is non-serious.The events are medically assessed as associated with the use of the device.

Event Description

Event verbatim [preferred term] skin reaction (wound with formation of crusts), allergic reaction [hypersensitivity] , skin reaction (wound with formation of crusts) [skin wound] , skin reaction (wound with formation of crusts) [scab] , scar [scar] , used thermacare lower back & hip for cervical and thoracic/ continued to take thermacare for cervical spine [intentional device use issue] ,.Case narrative:this is a spontaneous report from a pfizer-sponsored program, brand websites for devision consumer healthcare germany.A 48-year-old female patient, started to receive thermacare heatwrap (thermacare lower back & hip), via an unspecified route of administration from an unspecified date since years at an unspecified dose as needed for chronic back pain.The patient medical history was not reported.No concomitant medication administered.The patient stated on 04jan2017 she used thermacare for back pain (cervical and thoracic) and she experienced a skin reaction (wound with formation of crusts) after 5 min of using the heat wrap.The consumer removed the thermacare immediately due to this allergic reaction.As treatment for the events "skin reaction (wound with formation of crusts), allergic reaction" she used a cortisone ointment.No hospitalization needed.Patient continued to use thermacare as needed but "as gel or for cervical spine not more than point patch." the outcome of the events "skin reaction (wound with formation of crusts), allergic reaction" was resolved with sequel (scar) and for the event "scar" and "used thermacare lower back & hip for cervical and thoracic/ continued to take thermacare for cervical spine" was unknown.Product investigation results were as follows: 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.Severity of harm was n/a.Follow-up (12feb2017): new information received from the contactable consumer includes: patient age, product dosage frequency, onset date and outcome for initial events "skin reaction (wound with formation of crusts), allergic reaction" and new events "scar" and "used thermacare lower back & hip for cervical and thoracic/ continued to take thermacare for cervical spine".Follow-up attempts completed.No further information expected.Follow-up (13jan2017): this follow-up report is being submitted to upgrade this case to a reportable mdr.Follow-up (19dec2019): this follow-up is being submitted to notify that an investigation of the device is ongoing.Follow-up (20dec2019): new information received from product quality group includes investigation summary.Company clinical evaluation comment: based on the information provided, the events hypersensitivity, skin wound, scab and scar as described are considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.The event intentional device use issue is non-serious.The events are medically assessed as associated with the use of the device., comment: based on the information provided, the events hypersensitivity, skin wound, scab and scar as described are considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.The event intentional device use issue is non-serious.The events are medically assessed as associated with the use of the device.

Manufacturer Narrative

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.Severity of harm was n/a.

Event Description

Event verbatim [preferred term] skin reaction (wound with formation of crusts), allergic reaction [hypersensitivity] , skin reaction (wound with formation of crusts) [skin wound] , skin reaction (wound with formation of crusts) [scab] , scar [scar] , used thermacare lower back & hip for cervical and thoracic/ continued to take thermacare for cervical spine [intentional device use issue].Case narrative:this is a spontaneous report from a pfizer-sponsored program, brand websites for division consumer healthcare germany.A 48-year-old female patient, started to receive thermacare heatwrap (thermacare lower back & hip), via an unspecified route of administration from an unspecified date since years at an unspecified dose as needed for chronic back pain.The patient medical history was not reported.No concomitant medication administered.The patient stated on (b)(6) 2017 she used thermacare for back pain (cervical and thoracic) and she experienced a skin reaction (wound with formation of crusts) after 5 min of using the heat wrap.The consumer removed the thermacare immediately due to this allergic reaction.As treatment for the events "skin reaction (wound with formation of crusts), allergic reaction" she used a cortisone ointment.No hospitalization needed.Patient continued to use thermacare as needed but "as gel or for cervical spine not more than point patch." the outcome of the events "skin reaction (wound with formation of crusts), allergic reaction" was resolved with sequel (scar) and for the event "scar" and "used thermacare lower back & hip for cervical and thoracic/ continued to take thermacare for cervical spine" was unknown.Additional information has been requested and will be provided as it becomes available.Follow-up (12feb2017): new information received from the contactable consumer includes: patient age, product dosage frequency, onset date and outcome for initial events "skin reaction (wound with formation of crusts), allergic reaction" and new events "scar" and "used thermacare lower back & hip for cervical and thoracic/ continued to take thermacare for cervical spine".Follow-up attempts completed.No further information expected.Follow-up (13jan2017): this follow-up report is being submitted to upgrade this case to a reportable mdr.Follow-up (19dec2019): this follow-up is being submitted to notify that an investigation of the device is ongoing.Company clinical evaluation comment: based on the information provided, the events hypersensitivity, skin wound, scab and scar as described are considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.The event intentional device use issue is non-serious.The events are medically assessed as associated with the use of the device., comment: based on the information provided, the events hypersensitivity, skin wound, scab and scar as described are considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.The event intentional device use issue is non-serious.The events are medically assessed as associated with the use of the device.

Manufacturer Narrative

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.Severity of harm was n/a.

Event Description

Event verbatim [preferred term] skin reaction (wound with formation of crusts), allergic reaction [hypersensitivity] , skin reaction (wound with formation of crusts) [skin wound] , skin reaction (wound with formation of crusts) [scab] , scar [scar] , used thermacare lower back & hip for cervical and thoracic/ continued to take thermacare for cervical spine [intentional device use issue].Case narrative:this is a spontaneous report from a pfizer-sponsored program, brand websites for division consumer healthcare germany.A 48-year-old female patient, started to receive thermacare heatwrap (thermacare lower back & hip), via an unspecified route of administration from an unspecified date since years at an unspecified dose as needed for chronic back pain.The patient medical history was not reported.No concomitant medication administered.The patient stated on (b)(6) 2017 she used thermacare for back pain (cervical and thoracic) and she experienced a skin reaction (wound with formation of crusts) after 5 min of using the heat wrap.The consumer removed the thermacare immediately due to this allergic reaction.As treatment for the events "skin reaction (wound with formation of crusts), allergic reaction" she used a cortisone ointment.No hospitalization needed.Patient continued to use thermacare as needed but "as gel or for cervical spine not more than point patch." the outcome of the events "skin reaction (wound with formation of crusts), allergic reaction" was resolved with sequel (scar) and for the event "scar" and "used thermacare lower back & hip for cervical and thoracic/ continued to take thermacare for cervical spine" was unknown.Product investigation results were as follows: 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.Severity of harm was n/a.Follow-up (12feb2017): new information received from the contactable consumer includes: patient age, product dosage frequency, onset date and outcome for initial events "skin reaction (wound with formation of crusts), allergic reaction" and new events "scar" and "used thermacare lower back & hip for cervical and thoracic/ continued to take thermacare for cervical spine".Follow-up attempts completed.No further information expected.Follow-up (13jan2017): this follow-up report is being submitted to upgrade this case to a reportable mdr.Follow-up (19dec2019): this follow-up is being submitted to notify that an investigation of the device is ongoing.Follow-up (20dec2019): new information received from product quality group includes investigation summary.Follow-up (24feb2020): this follow-up is being submitted to notify that the investigation is closed; no further results are expected., comment: based on the information provided, the events hypersensitivity, skin wound, scab and scar as described are considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.The event intentional device use issue is non-serious.The events are medically 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.Product effect varies with each individual.No remedial action/corrective action/field safety corrective action is suggested at this time.

• Brand Name: THERMACARE LOWER BACK & HIP
• Type of Device: DISPOSABLE PACK, HOT
• Manufacturer (Section D): PFIZER CONSUMER HEALTH CARE; 1231 wyandotte drive; albany GA 31705
• MDR Report Key: 9257497
• MDR Text Key: 180783389
• Report Number: 1066015-2019-00290
• 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: 01/13/2017

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?: No
• Device Operator: Lay User/Patient
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/30/2019
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 12/23/2019; 12/31/2019; 03/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 48 YR