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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PFIZER CONSUMER HEALTH CARE THERMACARE LOWER BACK & HIP; DISPOSABLE PACK, HOT
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PFIZER CONSUMER HEALTH CARE THERMACARE LOWER BACK & HIP; DISPOSABLE PACK, HOT Back to Search Results
Lot Number EE3306
Device Problem Use of Device Problem (1670)
Patient Problems Itching Sensation (1943); Peeling (1999); Burn, Thermal (2530); Skin Burning Sensation (4540)
Event Date 12/01/2020
Event Type  Injury  
Event Description
Burned the skin on her back/something felt itchy and stinging [thermal burn], she has an open wound on the back [back injury], peeled the skin off [skin exfoliation], used thermacare lower back & hip for lower back pain because she has lupus/read the usage instructions on thermacare [intentional device misuse], narrative: this is a spontaneous report from a contactable consumer (patient).A (b)(6) female patient started to receive thermacare heatwrap (thermacare lower back & hip), device lot number ee3306, expiration date 30sep2023, via an unspecified route of administration from (b)(6) 2020 at unknown dosage for lower back pain because she had lupus.Medical history included lupus, the patient was currently under the care of a physician for lupus and sensitive skin probably because of lupus.The patient had no diabetes, no poor circulation, no heart disease, no difficulty feeling heat or pain on skin, no rheumatoid arthritis, no decreased sensation and no neuropathy.She had no abnormal skin conditions.There were no concomitant medications.The patient had previously not used thermacare.The patient had previously not used other heat products for pain relief (electric heating pad, hot water bottle, microwave gel pack).She purchased red box.The patient stated she only wore thermacare backwrap 6 hours and it burned the skin on her back on.She had pictures of the burn.This happened on saturday night, (b)(6) 2020.This was the first time she had ever used the product.A friend referred her and said it would help her back.It was like a heating pad that she could just throw away.She was laying down and something felt itchy and stinging.Her daughter looked and was able to see that it had burned her.She had not been putting anything on her skin.She wore granny panties and it was over the clothing.The adhesive was attached to the clothing.She did not engage in exercise while using the product.Her daughter checked her skin under the product while wearing thermacare.She read the usage instructions on thermacare before she used the product.About 4 to 5 hours the itching and stinging started.She had a burn on the back.She had an open wound on the back in (b)(6) 2020.She was using neosporin on it.She did not consult a healthcare professional for the symptoms.She stopped using it when it burned her.She will have a scar on the back because it peeled the skin off in (b)(6) 2020.She did not see manufacturer on the product.Packaging was sealed and intact.There was two in the box.The product that burned her had been thrown out.The other one from the box she still had and she could return it if needed.Device was available for evaluation.Action taken with the thermacare heatwrap in response to the events was permanently discontinued on (b)(6) 2020.The outcome of the events burned the skin on her back/something felt itchy and stinging, open wound on the back and peeled the skin off were not resolved.The reporter considered that there was a reasonable possibility that the event burned the skin on her back was related to the device.Additional information has been requested and will be provided as it becomes available.
 
Event Description
Event verbatim [preferred term].Burned the skin on her back/something felt itchy and stinging [thermal burn], she has an open wound on the back [back injury], peeled the skin off [skin exfoliation], used thermacare lower back & hip for lower back pain because she has lupus/read the usage instructions on thermacare [intentional device misuse].Narrative: this is a spontaneous report from a contactable consumer (patient).A 47-year-old female patient started to receive thermacare heatwrap (thermacare lower back & hip), device lot number ee3306, expiration date 30sep2023, via an unspecified route of administration on (b)(6) 2020 at unknown dosage for lower back pain because she had lupus.Medical history included disease, no difficulty feeling heat or pain on skin, no rheumatoid arthritis, no decreaselupus, the patient was currently under the care of a physician for lupus and sensitive skin probably because of lupus.The patient had no diabetes, no poor circulation, no heart d sensation and no neuropathy.She had no abnormal skin conditions.There were no concomitant medications.The patient had previously not used thermacare.The patient had previously not used other heat products for pain relief (electric heating pad, hot water bottle, microwave gel pack).She purchased red box.The patient stated she only wore thermacare backwrap 6 hours and it burned the skin on her back on.She had pictures of the burn.This happened on saturday night, (b)(6) 2020.This was the first time she had ever used the product.A friend referred her and said it would help her back.It was like a heating pad that she could just throw away.She was laying down and something felt itchy and stinging.Her daughter looked and was able to see that it had burned her.She had not been putting anything on her skin.She wore granny panties and it was over the clothing.The adhesive was attached to the clothing.She did not engage in exercise while using the product.Her daughter checked her skin under the product while wearing thermacare.She read the usage instructions on thermacare before she used the product.About 4 to 5 hours the itching and stinging started.She had a burn on the back.She had an open wound on the back in (b)(6) 2020.She was using neosporin on it.She did not consult a healthcare professional for the symptoms.She stopped using it when it burned her.She will have a scar on the back because it peeled the skin off in (b)(6) 2020.She did not see manufacturer on the product.Packaging was sealed and intact.There was two in the box.The product that burned her had been thrown out.The other one from the box she still had and she could return it if needed.Device was available for evaluation.Action taken with the thermacare heatwrap in response to the events was permanently discontinued on (b)(6) 2020.The outcome of the events burned the skin on her back/something felt itchy and stinging, open wound on the back and peeled the skin off were not resolved.The reporter considered that there was a reasonable possibility that the event burned the skin on her back was related to the device.According to the product quality complaint group: summary of investigation: batch ee3306 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.The device history record (dhr), reserve samples, and trending were evaluated.No quality issues were identified.Lot trend assessment and rationale: an evaluation of the complaint history confirms that this is the first complaint about the subclass 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 lot.Expedite trend assessment and rationale: an evaluation was made by searching for possible trends for this subclass requiring investigation by the site.Based on this citi search, there is not a trend identified for the subclass of adverse event/serious/unknown.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 the wrap caused "it burned the skin on her back." the consumer's report stating the wrap burned the skin on her back is inconclusive since the records review does not provide evidence to support the defective product.The product effect may vary with each individual.Care should be taken when using the device.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, an inspection of retained samples.Retained samples met the product description, and the product is within the expiration date.This complaint does not impact the product quality for the batch.Root cause/capa: process related was no.Final confirmation status was not confirmed.Site sample status was not received.Follow-up (05jan2021): follow-up attempts are completed.No further information is expected.Follow up (07jan2021): new information received from the product quality complaint group includes investigational results.Follow-up attempts are completed.No further information is expected.
 
Manufacturer Narrative
Summary of investigation: batch ee3306 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.The device history record (dhr), reserve samples, and trending were evaluated.No quality issues were identified.Lot trend assessment and rationale: an evaluation of the complaint history confirms that this is the first complaint about the subclass 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 lot.Expedite trend assessment and rationale: an evaluation was made by searching for possible trends for this subclass requiring investigation by the site.Based on this citi search, there is not a trend identified for the subclass of adverse event/serious/unknown.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 the wrap caused "it burned the skin on her back." the consumer's report stating the wrap burned the skin on her back is inconclusive since the records review does not provide evidence to support the defective product.The product effect may vary with each individual.Care should be taken when using the device.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, an inspection of retained samples.Retained samples met the product description, and the product is within the expiration date.This complaint does not impact the product quality for the batch.Root cause/capa: process related was no.Final confirmation status was not confirmed.Site sample status was not received.
 
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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 Key11108607
MDR Text Key225162981
Report Number1066015-2021-00001
Device Sequence Number1
Product Code IMD
Combination Product (y/n)N
PMA/PMN Number
K953442
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Type of Report Initial,Followup
Report Date 12/22/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/04/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Expiration Date09/30/2023
Device Lot NumberEE3306
Was Device Available for Evaluation? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age47 YR
Patient Weight78
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