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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 T48928
Device Problems Packaging Problem (3007); Torn Material (3024)
Patient Problem Partial thickness (Second Degree) Burn (2694)
Event Date 10/01/2017
Event Type  Injury  
Manufacturer Narrative
The root cause category is non-assignable (complaint not confirmed).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.After a review of the batch thermal records, thermal results met the required wrap batch average temperatures (37.6°c - 41.6°c) per spec-#, effective: 08jun2017.A corrective action procedure for individual cell temperature (individual cell temperature result below the lower specification limit of 35.8°c as stated in spec-#) was completed for run day two per sop 54615 product quality control cap procedure, effective date: 14dec2015.The cap was completed for wraps with cold cells.Wrap samples were pulled from the same hour of production as the wraps with cold cells.The required resample wrap thermal results all met product release criteria.Consumer alleges burn from wrap.The cause of the alleged burn is inconclusive since review of records does not provide evidence to support defective product.The product effect may vary with each individual.The product quality for the batch is not impacted by this complaint.The root cause category is non assignable (complaint not confirmed).Evaluation of the consumer returned sample shows the belt end with the hook attached has separated from the wrap.Evaluation of the sample by technical services determined the belt was properly bonded to the wrap as evidenced by the marks on the belt ends at the bond site made by the ultrasonic bonder.The bond was present during manufacturing and was pulled apart, most likely during application for use.The root cause of the belt separating from the wrap did not occur during manufacturing.Our manufacturing operations employ quality control procedures which include in process testing, and visual inspection, to ensure the quality of the product.
 
Event Description
Event verbatim [preferred term] burn blister larger than a quarter, smaller than a half dollar on the right side of her back by her hip area [burns second degree] , something wrong with both of the heatwraps, there was a piece of fabric right next to the cells that was ripped and just hanging there [device issue].Case narrative:this is a spontaneous report from a contactable retired nurse.An (b)(6) caucasian female patient started to use thermacare heatwrap (thermacare lower back & hip) (device lot number t48928, expiration date jun2020, upc number: 0573301003) from an unspecified date at 1 heatwrap at a time for back pain.There was no medical history reported and no concomitant medications.Past product history included thermacare heatwraps (thermacare heatwraps) from an unspecified date for an unspecified indication with no adverse effect.The nurse reported she bought a 2 count box of the product and stated that there was something wrong with both of the heatwraps.She stated there was a piece of fabric right next to the cells that was ripped and just hanging there.She said that it was on both of them.The patient mentioned the heatwraps would not stay on right.The box was messed up when she purchased it.She said that it was the last one in the store and that was why she purchased it.The patient said that these were the only things that help her back pain though.On an unspecified date in (b)(6) 2017, the patient reported she used the heatwraps and ended up with a burn blister larger than a quarter, smaller than a half dollar on the right side of her back by her hip area.She said that she got them a lot from these.The patient stated that she did not feel the one she had anymore and said that it was healed.She said that she got some doozy blisters from the thermacare heatwraps.She thought it was because she was more sensitive.She said that the burn blisters were on her back when she got them and she couldn't see them, she could only feel them.She used silvadene burn cream on it to bring relief.No surgical intervention was required.The patient was not admitted to the hospital as a result of the event.She did not provide any further information on any other thermacare heatwraps that had caused her blisters in the past.The patient stated there were no relevant tests to report.The nurse considered the event related to thermacare heatwraps.Action taken in response to the event for thermacare heatwrap was dose not changed.Therapeutic measures taken included silvadene burn cream.Clinical outcome of the event was resolved on an unspecified date in (b)(6) 2017.According to the product quality complaint group on (b)(6) 2017, the root cause category is non-assignable (complaint not confirmed).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.After a review of the batch thermal records, thermal results met the required wrap batch average temperatures (37.6°c - 41.6°c) per spec-#, effective: 08jun2017.A corrective action procedure for individual cell temperature (individual cell temperature result below the lower specification limit of 35.8°c as stated in spec-#) was completed for run day two per sop 54615 product quality control cap procedure, effective date: 14dec2015.The cap was completed for wraps with cold cells.Wrap samples were pulled from the same hour of production as the wraps with cold cells.The required resample wrap thermal results all met product release criteria.Consumer alleges burn from wrap.The cause of the alleged burn is inconclusive since review of records does not provide evidence to support defective product.The product effect may vary with each individual.The product quality for the batch is not impacted by this complaint.According to the product quality complaint group on (b)(6) 2017, the root cause category is non assignable (complaint not confirmed).Evaluation of the consumer returned sample shows the belt end with the hook attached has separated from the wrap.Evaluation of the sample by technical services determined the belt was properly bonded to the wrap as evidenced by the marks on the belt ends at the bond site made by the ultrasonic bonder.The bond was present during manufacturing and was pulled apart, most likely during application for use.The root cause of the belt separating from the wrap did not occur during manufacturing.Our manufacturing operations employ quality control procedures which include in process testing, 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 and the product is within expiration date.Additional information has been requested and will be provided as it becomes available.Follow-up (03nov2017): new information received from product quality complaints included: product quality investigation results.Follow-up (06dec2017): new information received from a contactable nurse includes: added event treatment.Case upgraded to serious.New information received from product quality complaints included: product quality investigation results.In addition, this is a follow-up report combining information from duplicate reports 2017465487 and 2017465071.The current and all subsequent follow-up information will be reported under manufacturer report number 2017465071.The new information copied from 2017465487 includes: more event details, event treatment and no hospitalization required.Company clinical evaluation comment: based on the information provided, the events of "burn blister" and "device issue" 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.The review of the lot/batch records does not suggest a defect or quality issue related to the manufacture of this lot.No device malfunction has been identified., comment: based on the information provided, the events of "burn blister" and "device issue" 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.The review of the lot/batch records does not suggest a defect or quality issue related to the manufacture of this lot.No device malfunction has been identified.
 
Manufacturer Narrative
The root cause category is non-assignable (complaint not confirmed).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.After a review of the batch thermal records, thermal results met the required wrap batch average temperatures (37.6°c - 41.6°c) per spec-#, effective: 08jun2017.A corrective action procedure for individual cell temperature (individual cell temperature result below the lower specification limit of 35.8°c as stated in spec-#) was completed for run day two per sop (b)(4) product quality control cap procedure, effective date: 14dec2015.The cap was completed for wraps with cold cells.Wrap samples were pulled from the same hour of production as the wraps with cold cells.The required resample wrap thermal results all met product release criteria.Consumer alleges burn from wrap.The cause of the alleged burn is inconclusive since review of records does not provide evidence to support defective product.The product effect may vary with each individual.The product quality for the batch is not impacted by this complaint.The root cause category is non assignable (complaint not confirmed).Evaluation of the consumer returned sample shows the belt end with the hook attached has separated from the wrap.Evaluation of the sample by technical services determined the belt was properly bonded to the wrap as evidenced by the marks on the belt ends at the bond site made by the ultrasonic bonder.The bond was present during manufacturing and was pulled apart, most likely during application for use.The root cause of the belt separating from the wrap did not occur during manufacturing.Our manufacturing operations employ quality control procedures which include in process testing, and visual inspection, to ensure the quality of the product.
 
Event Description
Event verbatim [preferred term] burn blister larger than a quarter, smaller than a half dollar on the right side of her back by her hip area [burns second degree] , something wrong with both of the heatwraps, there was a piece of fabric right next to the cells that was ripped and just hanging there [device issue] ,.Case narrative:this is a spontaneous report from a contactable retired nurse.An (b)(6) caucasian female patient started to use thermacare heatwrap (thermacare lower back & hip) (device lot number t48928, expiration date jun2020, upc number: 0573301003) from an unspecified date at 1 heatwrap at a time for back pain.There was no medical history reported and no concomitant medications.Past product history included thermacare heatwraps (thermacare heatwraps) from an unspecified date for an unspecified indication with no adverse effect.The nurse reported she bought a 2 count box of the product and stated that there was something wrong with both of the heatwraps.She stated there was a piece of fabric right next to the cells that was ripped and just hanging there.She said that it was on both of them.The patient mentioned the heatwraps would not stay on right.The box was messed up when she purchased it.She said that it was the last one in the store and that was why she purchased it.The patient said that these were the only things that help her back pain though.On an unspecified date in (b)(6) 2017, the patient reported she used the heatwraps and ended up with a burn blister larger than a quarter, smaller than a half dollar on the right side of her back by her hip area.She said that she got them a lot from these.The patient stated that she did not feel the one she had anymore and said that it was healed.She said that she got some doozy blisters from the thermacare heatwraps.She thought it was because she was more sensitive.She said that the burn blisters were on her back when she got them and she couldn't see them, she could only feel them.She used silvadene burn cream on it to bring relief.No surgical intervention was required.The patient was not admitted to the hospital as a result of the event.She did not provide any further information on any other thermacare heatwraps that had caused her blisters in the past.The patient stated there were no relevant tests to report.The nurse considered the event related to thermacare heatwraps.Action taken in response to the event for thermacare heatwrap was dose not changed.Therapeutic measures taken included silvadene burn cream.Clinical outcome of the event was resolved on an unspecified date in (b)(6) 2017.According to the product quality complaint group on 03nov2017, the root cause category is non-assignable (complaint not confirmed).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.After a review of the batch thermal records, thermal results met the required wrap batch average temperatures (37.6°c - 41.6°c) per spec-#, effective: 08jun2017.A corrective action procedure for individual cell temperature (individual cell temperature result below the lower specification limit of 35.8°c as stated in spec-#) was completed for run day two per sop 54615 product quality control cap procedure, effective date: 14dec2015.The cap was completed for wraps with cold cells.Wrap samples were pulled from the same hour of production as the wraps with cold cells.The required resample wrap thermal results all met product release criteria.Consumer alleges burn from wrap.The cause of the alleged burn is inconclusive since review of records does not provide evidence to support defective product.The product effect may vary with each individual.The product quality for the batch is not impacted by this complaint.According to the product quality complaint group on 06dec2017, the root cause category is non assignable (complaint not confirmed).Evaluation of the consumer returned sample shows the belt end with the hook attached has separated from the wrap.Evaluation of the sample by technical services determined the belt was properly bonded to the wrap as evidenced by the marks on the belt ends at the bond site made by the ultrasonic bonder.The bond was present during manufacturing and was pulled apart, most likely during application for use.The root cause of the belt separating from the wrap did not occur during manufacturing.Our manufacturing operations employ quality control procedures which include in process testing, 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 and the product is within expiration date.Additional information has been requested and will be provided as it becomes available.Follow-up (03nov2017): new information received from product quality complaints included: product quality investigation results.Follow-up (06dec2017): new information received from a contactable nurse includes: added event treatment.Case upgraded to serious.New information received from product quality complaints included: product quality investigation results.In addition, this is a follow-up report combining information from duplicate reports (b)(4).The current and all subsequent follow-up information will be reported under manufacturer report number (b)(4).The new information copied from (b)(4) includes: more event details, event treatment and no hospitalization required.Follow up (27dec2017): new information received from a contactable nurse includes: the nurse declined physician information and requested no further contact.Follow-up attempts are completed.No further information is expected.Company clinical evaluation comment: based on the information provided, the events of "burn blister" and "device issue" 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.The review of the lot/batch records does not suggest a defect or quality issue related to the manufacture of this lot.No device malfunction has been identified., comment: based on the information provided, the events of "burn blister" and "device issue" 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.The review of the lot/batch records does not suggest a defect or quality issue related to the manufacture of this lot.No device malfunction has been identified.
 
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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 Key7115285
MDR Text Key94798728
Report Number1066015-2017-00178
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 health professional
Type of Report Initial,Followup
Report Date 10/25/2017
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? Yes
Device Operator Lay User/Patient
Device Expiration Date06/01/2020
Device Lot NumberT48928
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received12/13/2017
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received01/02/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age81 YR
Patient Weight55
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