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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 S23841; S23842
Device Problems Loss of or Failure to Bond (1068); Unexpected Therapeutic Results (1631); Use of Device Problem (1670); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Pain (1994); Skin Irritation (2076)
Event Date 01/01/2017
Event Type  Injury  
Event Description
Event verbatim [preferred term] her skin is peeled off [skin exfoliation] , when they did they left marks [skin pressure mark] , hurts when the duct tape is ripped off [pain] , other ones that didn't work [device ineffective] , doctor recommended product for pinched a nerve and ended up with sciatica [device use issue] , there was no sticky stuff on the ends and the product did not stick at all / wrap did not stick to her back, when they did they left marks and her skin was peeled off [product complaint] ,.Case narrative: this is a spontaneous report from a contactable consumer.This (b)(6)-years-old female patient started to receive thermacare heatwrap (thermacare lower back & hip), device lot number: s23841; s23842, expiration date: may2020, from an unspecified date for pinched a nerve and ended up with sciatica.Medical history included disabled since 2013 and ongoing.Concomitant medications were not reported.Consumer reported that she pinched a nerve and ended up with sciatica.Her doctor told her to use thermacare.She informed that she has to have back surgery and is going to an orthopedic on (b)(6) 2017 for pain management.She has been disabled since 2013.On an unspecified date, she bought a box of the small lower back and hip heatwraps and there was no sticky stuff on the ends and the product did not stick at all.She had to duct tape every single wrap onto her during (b)(6) 2017.She reported it hurts when the duct tape is ripped off (in 2017).She later further described that the wrap did not stick to her back, and when they did they left marks and her skin was peeled off.She bought another box of the back wraps on (b)(6) 2017, and those seem to be working.She is upset that she spent money on the other ones that didn't work.There was no damage to the boxes and they were sealed.She did not have the product as she had thrown them away.The action taken and event outcome were unknown.Additional information has been requested and will be provided as it becomes available.Follow-up (13nov2017): new information received form product quality complaint group included: new events (when they did they left marks and her skin was peeled off).Follow-up attempts are completed.No further information is expected.Follow-up (13nov2017): this follow-up report is being submitted to upgrade this case to a reportable medical device report.Company clinical evaluation comment: based on the information provided, the event skin exfoliation as described is considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.The other events are non-serious.The events are medically assessed as associated with the use of the device., comment: based on the information provided, the event skin exfoliation as described is considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.The other events are non-serious.The events are medically assessed as associated with the use of the device.
 
Manufacturer Narrative
Severity of harm was s1 for complaint sub-class: adhesion/fastening defect.Summary of investigation: batch s23841 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.Conclusion: the root cause category is non assignable (complaint not confirmed quality defect).Sample is not available for evaluation by the site; complaint cannot be confirmed.Our manufacturing operations employ quality control procedures which include statistical sampling and visual inspection, to ensure the quality of the product being packaged.No quality issues were identified upon this review of the batch device history record, in process attributes and variable quality checks or, inspection of retained samples.Retained samples met the product description.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 adhesion/fastening defect received at the albany site requiring an evaluation for this batch.The complaint was evaluated to identify any potential trend.The calculated complaints per million produced (cpmp) result of 5 was below the upper control limit (ucl) of 189.5 complaints per sop-# "complaint trending guideline," effective 24feb2020.On this basis, a trend does not exist for this batch.Return sample not received at the site.
 
Event Description
Event verbatim [preferred term], her skin is peeled off [skin exfoliation], other ones that didn't work [device ineffective], hurts when the duct tape is ripped off [pain], when they did they left marks [skin pressure mark], there was no sticky stuff on the ends and the product did not stick at all / wrap did not stick to her back, when they did they left marks and her skin was peeled off [device issue], doctor recommended product for pinched a nerve and ended up with sciatica [device use issue], , narrative: this is a spontaneous report from a contactable consumer.This 32-year-old female patient started to receive thermacare heatwrap (thermacare lower back & hip), device lot number: s23841; s23842, expiration date: may2020, from an unspecified date for pinched a nerve and ended up with sciatica.Medical history included disabled since 2013 and ongoing.Concomitant medications were not reported.Consumer reported that she pinched a nerve and ended up with sciatica.Her doctor told her to use thermacare.She informed that she has to have back surgery and is going to an orthopedic on (b)(6) 2017 for pain management.She has been disabled since 2013.On an unspecified date, she bought a box of the small lower back and hip heatwraps and there was no sticky stuff on the ends and the product did not stick at all.She had to duct tape every single wrap onto her during (b)(6) 2017.She reported it hurts when the duct tape is ripped off (in 2017).She later further described that the wrap did not stick to her back, and when they did they left marks and her skin was peeled off in 2017.She bought another box of the back wraps on (b)(6) 2017, and those seem to be working.She is upset that she spent money on the other ones that didn't work.There was no damage to the boxes and they were sealed.She did not have the product as she had thrown them away.The action taken and event outcome were unknown.According to product quality group: severity of harm was s1 for complaint sub-class: adhesion/fastening defect.Summary of investigation: batch s23841 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.Conclusion: the root cause category is non assignable (complaint not confirmed quality defect).Sample is not available for evaluation by the site; complaint cannot be confirmed.Our manufacturing operations employ quality control procedures which include statistical sampling and visual inspection, to ensure the quality of the product being packaged.No quality issues were identified upon this review of the batch device history record, in process attributes and variable quality checks or, inspection of retained samples.Retained samples met the product description.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 adhesion/fastening defect received at the albany site requiring an evaluation for this batch.The complaint was evaluated to identify any potential trend.The calculated complaints per million produced (cpmp) result of 5 was below the upper control limit (ucl) of 189.5 complaints per sop-# "complaint trending guideline," effective 24feb 2020.On this basis, a trend does not exist for this batch.Return sample not received at the site.Follow-up (13nov2017): new information received form product quality complaint group included: new events (when they did they left marks and her skin was peeled off).Follow-up attempts are completed.No further information is expected.Follow-up (13nov2017): this follow-up report is being submitted to upgrade this case to a reportable medical device report.Follow-up (01jun2020): new information received from product quality complaint group includes investigation results.Follow-up attempts are completed.No further information is expected.
 
Event Description
Event verbatim [preferred term].Her skin is peeled off [skin exfoliation], other ones that didn't work [device ineffective], hurts when the duct tape is ripped off [pain], when they did they left marks [skin pressure mark], there was no sticky stuff on the ends and the product did not stick at all / wrap did not stick to her back, when they did they left marks and her skin was peeled off [device issue].Doctor recommended product for pinched a nerve and ended up with sciatica [device use issue].Narrative: this is a spontaneous report from a contactable consumer.This 32-year-old female patient started to use thermacare heatwrap (thermacare lower back & hip) (device lot #1: s23841, expiration date: may2020; device lot #2: s23842, expiration date: mar2020) from an unspecified date for pinched a nerve and ended up with sciatica.Medical history included disabled since 2013 and ongoing.Concomitant medications were not reported.Consumer reported that she pinched a nerve and ended up with sciatica.Her doctor told her to use thermacare.She informed that she has to have back surgery and is going to an orthopedic on (b)(6) 2017 for pain management.She has been disabled since 2013.On an unspecified date, she bought a box of the small lower back and hip heatwraps and there was no sticky stuff on the ends and the product did not stick at all.She had to duct tape every single wrap onto her during (b)(6) 2017.She reported it hurts when the duct tape is ripped off (in 2017).She later further described that the wrap did not stick to her back, and when they did they left marks and her skin was peeled off in 2017.She bought another box of the back wraps on (b)(6) 2017, and those seem to be working.She is upset that she spent money on the other ones that didn't work.There was no damage to the boxes and they were sealed.She did not have the product with lot number s23841 as she had thrown them away.Action taken and event outcome were unknown.Additional information received from product quality complaint (pqc) group on 01jun2020 included investigation results.Severity of harm was s1 for complaint sub-class: adhesion/fastening defect.Summary of investigation: batch s23841 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.Conclusion: the root cause category is non assignable (complaint not confirmed quality defect).Sample is not available for evaluation by the site; complaint cannot be confirmed.Our manufacturing operations employ quality control procedures which include statistical sampling and visual inspection, to ensure the quality of the product being packaged.No quality issues were identified upon this review of the batch device history record, in process attributes and variable quality checks or, inspection of retained samples.Retained samples met the product description.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 adhesion/fastening defect received at the albany site requiring an evaluation for this batch.Return sample not received at the site.Additional information received from pqc group on 20apr2020.Investigation results dated (b)(6) 2020 were as follows: batch s23842 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.Conclusion: the root cause category is non assignable (complaint not confirmed as a quality defect).Consumer reports wrap "left marks and skin was peeled off." the cause of the consumer reporting the wrap "left marks and skin was peeled off" 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 and technical 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.After a review of the batch thermal records, thermal results all met product release criteria.The product quality for the batch is not impacted by this complaint.Reasonably suggest device malfunction: no.Severity of harm: n/a.A sample of the product with lot number s23842 is available to be returned.Follow-up (13nov2017): new information received form product quality complaint group included: new events (when they did they left marks and her skin was peeled off).Follow-up (13nov2017): this follow-up report is being submitted to upgrade this case to a reportable medical device report.Follow-up (01jun2020): new information received from product quality complaint group includes investigation results.Follow-up (20apr2020): new information received from product quality complaint group includes: product quality investigation results.No follow-up attempts needed.No further information is expected.Follow-up (20apr2020): this case is being submitted to notify that the follow-up information previously considered to have been initially received by the company on 18jul2020 was instead received on 20apr2020.
 
Manufacturer Narrative
Additional information received from product quality complaint (pqc) group on 01jun2020 included investigation results.Severity of harm was s1 for complaint sub-class: adhesion/fastening defect.Summary of investigation: batch s23841 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.Conclusion: the root cause category is non assignable (complaint not confirmed quality defect).Sample is not available for evaluation by the site; complaint cannot be confirmed.Our manufacturing operations employ quality control procedures which include statistical sampling and visual inspection, to ensure the quality of the product being packaged.No quality issues were identified upon this review of the batch device history record, in process attributes and variable quality checks or, inspection of retained samples.Retained samples met the product description.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 adhesion/fastening defect received at the albany site requiring an evaluation for this batch.Return sample not received at the site.Additional information received from pqc group on 20apr2020.Investigation results dated (b)(6) 2020 were as follows: batch s23842 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.Conclusion: the root cause category is non assignable (complaint not confirmed as a quality defect).Consumer reports wrap "left marks and skin was peeled off." the cause of the consumer reporting the wrap "left marks and skin was peeled off" 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 and technical 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.After a review of the batch thermal records, thermal results all met product release criteria.The product quality for the batch is not impacted by this complaint.Reasonably suggest device malfunction: no.Severity of harm: n/a.A sample of the product with lot number s23842 is available to be returned.
 
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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 Key9257851
MDR Text Key181987045
Report Number1066015-2019-00297
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,Followup
Report Date 11/03/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/30/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Expiration Date03/01/2020
Device Lot NumberS23841; S23842
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 Age32 YR
Patient Weight76
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