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

Lot Number 9008JA

Device Problem Nonstandard Device (1420)

Patient Problems Pain (1994); Swelling (2091); Patient Problem/Medical Problem (2688)

Event Date 03/01/2019

Event Type  Injury  

Event Description

Event verbatim [preferred term] blister on my lower back/blistered my back [blister], it made a cyst hurt more [cyst], it made a cyst hurt more/causing more pain [pain].Case narrative:this is a spontaneous report from a contactable consumer.This consumer reported similar events for 2 patients.This is the first of two reports, reporting for himself.This case is serious.The other case is non-serious.A (b)(6) year-old male patient started to receive thermacare heatwrap (thermacare lower back & hip), lot number 9008ja, expiration date: oct2021, upc number: (b)(4), from an unspecified date for constant mid back pain.The patient's medical history and concomitant medications were not reported.The patient experienced blister on his lower back on (b)(6) 2019 after using hem over a week.The patient stated he noticed when using them he began to blister on his lower back on (b)(6) 2019 then saw the recall and disposed of the them as fear other older members of his home would use them.The patient stated, 'i continue to use your other products and get great results'.The patient further stated he was not admitted to hospital but received treatment for blister on his lower back.He stated that thermacare use blistered his back.It made a cyst hurt more.He was told to remover it, but had to stop thermacare use and wait, causing more pain on (b)(6) 2019.Finally he had a surgery to remove the cyst, after stopping thermacare use was removed by physician in his office.The action taken in response to the events with thermacare heatwrap was permanently withdrawn on an unspecified date.The outcome of the event blister on lower back was not resolved and the outcome of the other events was unknown.Additional information has been requested and will be provided as it becomes available.Follow-up (09may2019): new information received from a contactable consumer (patient) included: lot number, expiration date and upc number of the suspect product and event details updated.Follow-up (31may2019): new information received from a contactable consumer includes patient data (age), device data (indication, action taken), new event (it made a cyst hurt more, causing more pain), onset date of event, outcome of event, deny of hospitalization, treatment details, event details and case upgraded to be serious, reportable mdr.Company clinical evaluation comment: based on the information provided, the events blister, cyst and pain 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 blister, cyst and pain 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.

Event Description

Event verbatim [preferred term] blister on my lower back/blistered my back/ blistering on back [blister] , it made a cyst hurt more [cyst] , casuing more pain/sore on back they had too be removed surgically [back pain] , was sleeping while wearing the product/did not check his skin under the product while wearing thermacare/using thermacare 12 hours per day/read the usage instructions on thermacare before he used the [intentional device misuse] ,.Case narrative:this is a spontaneous report from a contactable consumer.This consumer reported similar events for 2 patients.This is the first of two reports, reporting for himself.This case is serious.The other case is non-serious.A 69-year-old male patient started to receive thermacare heatwrap (thermacare lower back & hip), lot number 9008ja, expiration date: oct2021, upc number: 0573301038, from 01mar2019 to 11apr2019 for constant mid back pain and pain.Medical history included diabetes, poor circulation, heart disease, difficulty feeling heat or pain on skin, decreased sensation, neuropathy and he was currently under the care of a physician for the above medical condition, sensitive skin.He classified his skin tone as medium (neither light nor dark).The patient's concomitant medications were not reported.The patient previously did not use thermacare.He also did not use other heat products for pain relief (electric heating pad, hot water bottle, microwave gel pack).The patient experienced blister on his lower back on 01apr2019 after using hem over a week.The patient stated he noticed when using them he began to blister on his lower back on 01apr2019 then saw the recall and disposed of the them as fear other older members of his home would use them.The patient stated, 'i continue to use your other products and get great results'.The patient further stated he was not admitted to hospital but received treatment for blister on his lower back.He stated that thermacare use blistered his back.It made a cyst hurt more on an unspecified date.He was told to remover it, but had to stop thermacare use and wait, causing more pain on 20may2019.Finally he had a surgery to remove the cyst, after stopping thermacare use was removed by physician in his office.The patient further stated that he had abnormal skin condition: sore on back they had too be removed surgically.He purchased red box.There was no product remaining.He used thermacare 12 hours per day since 01mar2019.He was sleeping while wearing the product and did not check his skin under the product while wearing thermacare since 01mar2019.He did not engage in exercise while using the product.He read the usage instructions on thermacare before he used the product.He also stated that needed cyst removed had to wait because of blistering on back/ cyst had now been removed.He consulted his physician to understand the symptoms he experienced better.The action taken in response to the events with thermacare heatwrap was permanently withdrawn on 11apr2019.The outcome of the event blister on lower back was not resolved and the outcome of the other events was unknown.Additional information has been requested and will be provided as it becomes available.Follow-up (09may2019): new information received from a contactable consumer (patient) included: lot number, expiration date and upc number of the suspect product and event details updated.Follow-up (31may2019): new information received from a contactable consumer includes patient data (age), device data (indication, action taken), new event (it made a cyst hurt more, causing more pain), onset date of event, outcome of event, deny of hospitalization, treatment details, event details and case upgraded to be serious, reportable mdr.Follow-up (04jun2019): new information received from a contactable consumer includes medical history, device data (indication, start date, stop date) and information, new event (sore on back they had too be removed surgically, using thermacare 12 hours per day, was sleeping while wearing the product/did not check his skin under the product while wearing thermacare/read the usage instructions on thermacare before he used the product), onset date of events and event details.Company clinical evaluation comment: based on the information provided, the events blister, cyst, back pain and intentional device misuse 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 blister, cyst, back pain and intentional device misuse 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

Conclusion: 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 wraps caused "blisters." the cause of the consumer stating the wraps caused blisters 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.Lot trend assmt.& rationale: an evaluation of the complaint history 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.On the basis of this evaluation, a trend does not exist for this batch.

Event Description

Event verbatim [preferred term] blister on my lower back/blistered my back/ blistering on back [blister] , it made a cyst hurt more [cyst] , causing more pain/sore on back they had to be removed surgically [back pain] , sleeping while wearing the product/did not check skin under the product while wearing/using 12 hours per day/read usage instructions before he used the product [intentional device misuse] ,.Case narrative:this is a spontaneous report from a contactable consumer.This consumer reported similar events for 2 patients.This is the first of two reports, reporting for himself.A 69-year-old male patient started to receive thermacare heatwrap (thermacare lower back & hip), lot number 9008ja, expiration date: oct2021, upc number: 0573301038, from (b)(6) 2019 to (b)(6) 2019 for constant mid back pain and pain.Medical history included diabetes, poor circulation, heart disease, difficulty feeling heat or pain on skin, decreased sensation, neuropathy and he was currently under the care of a physician for the above medical condition, sensitive skin.He classified his skin tone as medium (neither light nor dark).The patient's concomitant medications were not reported.The patient previously did not use thermacare.He also did not use other heat products for pain relief (electric heating pad, hot water bottle, microwave gel pack).The patient experienced blister on his lower back on (b)(6) 2019 after using hem over a week.The patient stated he noticed when using them he began to blister on his lower back on (b)(6) 2019 then saw the recall and disposed of the them as fear other older members of his home would use them.The patient stated, 'i continue to use your other products and get great results'.The patient further stated he was not admitted to hospital but received treatment for blister on his lower back.He stated that thermacare use blistered his back.It made a cyst hurt more on an unspecified date.He was told to remover it, but had to stop thermacare use and wait, causing more pain on (b)(6) 2019.Finally he had a surgery to remove the cyst, after stopping thermacare use was removed by physician in his office.The patient further stated that he had abnormal skin condition: sore on back they had to be removed surgically.He purchased red box.There was no product remaining.He used thermacare 12 hours per day since (b)(6) 2019.He was sleeping while wearing the product and did not check his skin under the product while wearing thermacare since (b)(6) 2019.He did not engage in exercise while using the product.He read the usage instructions on thermacare before he used the product.He also stated that needed cyst removed had to wait because of blistering on back/ cyst had now been removed.He consulted his physician to understand the symptoms he experienced better.The action taken in response to the events with thermacare heatwrap was permanently withdrawn on (b)(6) 2019.The outcome of the event blister on lower back was not resolved and the outcome of the other events was unknown.According to product quality complaint group: conclusion: 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 wraps caused "blisters." the cause of the consumer stating the wraps caused blisters 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.Lot trend assmt.& rationale: an evaluation of the complaint history 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.On the basis of this evaluation, a trend does not exist for this batch.Follow-up (09may2019): new information received from a contactable consumer (patient) included: lot number, expiration date and upc number of the suspect product and event details updated.Follow-up (31may2019): new information received from a contactable consumer includes patient data (age), device data (indication, action taken), new event (it made a cyst hurt more, causing more pain), onset date of event, outcome of event, deny of hospitalization, treatment details, event details and case upgraded to be serious, reportable mdr.Follow-up (04jun2019): new information received from a contactable consumer includes medical history, device data (indication, start date, stop date) and information, new event (sore on back they had too be removed surgically, using thermacare 12 hours per day, was sleeping while wearing the product/did not check his skin under the product while wearing thermacare/read the usage instructions on thermacare before he used the product), onset date of events and event details.Follow-up (09aug2019): follow-up attempts completed.No further information expected.Follow-up (25oct2019): new information received from a product quality complaints group included: investigation results.Company clinical evaluation comment: based on the information provided, the events blister, cyst, back pain and intentional device misuse 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.No quality issues were identified upon this review of batch records, release testing data or, inspection of retained samples.The root cause category is non-assignable (complaint not confirmed as a quality defect).Product effect varies with each individual.No remedial action/corrective action/field safety corrective action is suggested at this time., comment: based on the information provided, the events blister, cyst, back pain and intentional device misuse 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.No quality issues were identified upon this review of batch records, release testing data or, inspection of retained samples.The root cause category is non-assignable (complaint not confirmed as a quality defect).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: 8693883
• MDR Text Key: 147863927
• Report Number: 1066015-2019-00187
• 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
• Report Date: 05/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/12/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/01/2021
• Device Lot Number: 9008JA
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 69 YR