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

Lot Number S23241

Device Problems Improper or Incorrect Procedure or Method (2017); Device Markings/Labelling Problem (2911)

Patient Problem Burn, Thermal (2530)

Event Date 08/01/2017

Event Type  Injury  

Manufacturer Narrative

The root cause category is non-assignable (complaint not confirmed).The consumer returned sample is not available from consumer for evaluation by the site, the complaint can not be confirmed.Possible root causes for complaint of never worked: process related defect: wrap not dosed with brine solution; process related defect: pouch leak allows air to get into the pouch; over time the wrap will expire.This defect can be caused by the following: pouch leak related to an insufficient seal, or pouch leak due to a hole in the pouch film, or other: pouch leak due to consumer mishandling that could cause the pouch to open or tear prior to use.The thermal data for the batch was reviewed and there were no thermal results outside the required specifications.A wrap not dosed with brine solution is highly unlikely; this defect if ongoing during manufacturing would be detected through the manufacturing attribute test and would be detected in the thermal testing (cold wraps).If the wraps' heat cells are not hard and are soft in nature, this would indicate brine solution was not present.To confirm a wrap with no brine solution added requires the wrap for evaluation unless the consumer indicates the heat cells or wrap was hard (not mentioned in the intake information).Process related pouch leak defects are difficult to determine once the pouch has been opened.The pti data for the batch was reviewed and there were no leak results outside the in process testing limits.The alleged defective wraps have not been received from the consumer for evaluation.Pouch leaks are considered a major attribute.Testing is performed on four pouched wraps every ten minutes of flow wrapper uptime (per spec-23451; effective date: 28-nov-2016) to minimize the occurrence of defective pouches in the batch.Maximum acceptable pouch leak fails are based on the number of the performed sample tests.Engilico equipment was added to the flow wrapper in (b)(6) 2017.It monitors the s.

Event Description

Used wrap directly on the skin and received burns [thermal burn] , used wrap directly on the skin and received burns [intentional device misuse] , put the lower back and hip heatwrap around her wrist, had read the usage instructions [intentional device use issue] , the warning on back of box was too small: she said that it should be on the front.[product use complaint], case narrative:this is a spontaneous report from a contactable consumer.A (b)(6) female patient of an unspecified ethnicity started to use thermacare heatwrap (thermacare lower back & hip) (lot number s23241; expiry date jan2020) from an unspecified date at 1 heatwrap daily for chronic lower back pain.No medical history or concomitant medications were reported.Past product history included thermacare heatwraps (thermacare heatwraps) from an unspecified date for an unspecified indication normally for 8 hours a day with no problems or symptoms.On an unspecified date in (b)(6) 2017 (reported as 3 weeks prior to the initial report) the patient put the lower back and hip heatwrap around her wrist, directly on the skin for 6 hours and experienced two bad burns.She was over 55; however, she said the warning on the back of the box was too small.She said that the warning should be on the front.The patient consulted a physician and received treatment for the burns which included an unspecified cream.The patient classified her skin tone as dark or olive.She denied having sensitive skin and denied abnormal skin conditions.The patient did not engage in exercise while using the heatwrap.She checked her skin under the heatwrap while using the heatwrap every 2 hours.The patient had read the usage instructions for the heatwrap prior to use, although she did not see the warning on the back of the box.Action taken in response to the events for the thermacare heatwrap was continued.Therapeutic measures taken for the burns included an unspecified cream.No hospitalization was required as a result of the events.Clinical outcome of the event burns was resolved on an unspecified date.The patient reported the event lasted approximately 2 weeks.Clinical outcome of the remaining events was unknown.According to product quality complaint group: the root cause category is non-assignable (complaint not confirmed).The consumer returned sample is not available from consumer for evaluation by the site, the complaint cannot be confirmed.Possible root causes for complaint of never worked: process related defect: wrap not dosed with brine solution; process related defect: pouch leak allows air to get into the pouch; over time the wrap will expire.This defect can be caused by the following: a) pouch leak related to an insufficient seal, or pouch leak due to a hole in the pouch film, or other: pouch leak due to consumer mishandling that could cause the pouch to open or tear prior to use.The thermal data for the batch was reviewed and there were no thermal results outside the required specifications.A wrap not dosed with brine solution is highly unlikely; this defect if ongoing during manufacturing would be detected through the manufacturing attribute test and would be detected in the thermal testing (cold wraps).If the wraps' heat cells are not hard and are soft in nature, this would indicate brine solution was not present.To confirm a wrap with no brine solution added requires the wrap for evaluation unless the consumer indicates the heat cells or wrap was hard (not mentioned in the intake information).Process related pouch leak defects are difficult to determine once the pouch has been opened.The pti data for the batch was reviewed and there were no leak results outside the in process testing limits.The alleged defective wraps have not been received from the consumer for evaluation.Pouch leaks are considered a major attribute.Testing is performed on four pouched wraps every ten minutes of flow wrapper uptime (per spec-(b)(4); effective date: 28-nov-2016) to minimize the occurrence of defective pouches in the batch.Maximum acceptable pouch leak fails are based on the number of the performed sample tests.Engilico equipment was added to the flow wrapper in (b)(6) 2017.It monitors the sealing motion of the flow wrapper anvils.Pouch leaks defects due to consumer mishandling cannot be confirmed once the pouch is opened for use.Our 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.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.The product quality for the batch is not impacted by this complaint.Additional information has been requested and will be provided as it becomes available.Follow-up (25oct2017): new information received from a contactable consumer includes: patient details (age), past product history, suspect product indication, action taken with the suspect product, reaction data (additional event intentional device use issue), events outcome, therapeutic measures taken and no hospitalization required.Follow-up attempts are completed.No further information is expected.Follow-up (30oct2017): new information received from product quality complaint group concluded: suspect product data (lot number, expiration date) and investigation results.Follow-up attempts are completed.No further information is expected.Follow-up (25oct2017): 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 of "burn" "intentional device misuse" as described are considered serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure.The events of "intentional device use issue" and "product label font size complaint" are non-serious.The events are medically assessed as associated with the use of the device., comment: based on the information provided, the events of "burn" "intentional device misuse" as described are considered serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure.The events of "intentional device use issue" and "product label font size complaint" are non-serious.The events are medically assessed as associated with the use of the device.

Event Description

Event verbatim [preferred term] used wrap directly on the skin and received burns [thermal burn] , used wrap directly on the skin and received burns [intentional device misuse] , put the lower back and hip heatwrap around her wrist, had read the usage instructions [intentional device use issue] , the warning on back of box was too small - she said that it should be on the front.[product use complaint].Case narrative:this is a spontaneous report from a contactable consumer.A 60-year-old female patient started to use thermacare heatwrap (thermacare lower back & hip) (lot number s23241; expiry date jan2020) from an unspecified date ("for a long time") at 1 heatwrap daily for chronic lower back pain.No medical history or concomitant medications were reported.Past product history included thermacare heatwraps (thermacare heatwraps) from an unspecified date for an unspecified indication normally for 8 hours a day with no problems or symptoms.On an unspecified date in (b)(6) 2017 (reported as 3 weeks prior to the initial report) the patient put the lower back and hip heatwrap around her wrist, directly on the skin for 6 hours and experienced two bad burns.She was over 55; however, she said the warning on the back of the box was too small.She said that the warning should be on the front.She said that if she had seen the warning she would not have applied it directly to her skin.The patient consulted a physician and received treatment for the burns which included an unspecified cream.The patient classified her skin tone as dark or olive.She denied having sensitive skin and denied abnormal skin conditions.The patient did not engage in exercise while using the heatwrap.She checked her skin under the heatwrap while using the heatwrap every 2 hours.The patient had read the usage instructions for the heatwrap prior to use, although she did not see the warning on the back of the box.She also reported that last time she bought 3 boxes and in one of them 2 of the heatwraps did not warm up at all.She still had the two wraps which did not work but she was not willing to return them.Action taken in response to the events for the thermacare heatwrap was continued.Therapeutic measures taken for the burns included an unspecified cream.No hospitalization was required as a result of the events.Clinical outcome of the event burns was resolved on an unspecified date.The patient reported the event lasted approximately 2 weeks.Clinical outcome of the remaining events was unknown.According to product quality complaint group: the root cause category is non-assignable (complaint not confirmed).The consumer returned sample is not available from consumer for evaluation by the site, the complaint cannot be confirmed.Possible root causes for complaint of never worked: 1) process related defect - wrap not dosed with brine solution; 2) process related defect - pouch leak allows air to get into the pouch; over time the wrap will expire.This defect can be caused by the following: a) pouch leak related to an insufficient seal, or b) pouch leak due to a hole in the pouch film, or 3) other - pouch leak due to consumer mishandling that could cause the pouch to open or tear prior to use.The thermal data for the batch was reviewed and there were no thermal results outside the required specifications.A wrap not dosed with brine solution is highly unlikely; this defect if ongoing during manufacturing would be detected through the manufacturing attribute test and would be detected in the thermal testing (cold wraps).If the wraps' heat cells are not hard and are soft in nature, this would indicate brine solution was not present.To confirm a wrap with no brine solution added requires the wrap for evaluation unless the consumer indicates the heat cells or wrap was hard (not mentioned in the intake information).Process related pouch leak defects are difficult to determine once the pouch has been opened.The pti data for the batch was reviewed and there were no leak results outside the in process testing limits.The alleged defective wraps have not been received from the consumer for evaluation.Pouch leaks are considered a major attribute.Testing is performed on four pouched wraps every ten minutes of flow wrapper uptime (per spec-23451; effective date: 28-nov-2016) to minimize the occurrence of defective pouches in the batch.Maximum acceptable pouch leak fails are based on the number of the performed sample tests.(b)(4)equipment was added to the flow wrapper in jan-2017.It monitors the sealing motion of the flow wrapper anvils.Pouch leaks defects due to consumer mishandling cannot be confirmed once the pouch is opened for use.Our 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.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.The product quality for the batch is not impacted by this complaint.Product quality complaints provided additional investigation results on 18dec2019: batch s23241 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).After a review of the batch thermal records, thermal results all met product release criteria.Consumer reports "experienced a burn." the cause of the consumer receiving burns 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.Follow-up (25oct2017): new information received from a contactable consumer includes: patient details (age), past product history, suspect product indication, action taken with the suspect product, reaction data (additional event intentional device use issue), events outcome, therapeutic measures taken and no hospitalization required.Follow-up attempts are completed.No further information is expected.Follow-up (30oct2017): new information received from product quality complaint group concluded: suspect product data (lot number, expiration date) and investigation results.Follow-up attempts are completed.No further information is expected.Follow-up (25oct2017): this follow-up report is being submitted to upgrade this case to a reportable mdr.Follow-up (18dec2019): new information received from product quality complaints includes: investigation results.This follow-up is also being submitted to amend the following information: narrative description (added thermacare use timeline "for a long time " and additional complaint details regarding "heatwraps did not warm up at all").No follow-up attempts are possible.No further information is expected., comment: based on the information provided, the events of "burn", "intentional device misuse" as described are considered serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure.The events of "intentional device use issue" and "product label font size complaint" are non-serious.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.In the case narrative there is evidence of intentional device misuse which most likely contributed to this incident.No remedial action/corrective action/field safety corrective action is suggested at this time.

Manufacturer Narrative

The root cause category is non-assignable (complaint not confirmed).The consumer returned sample is not available from consumer for evaluation by the site, the complaint can not be confirmed.Possible root causes for complaint of never worked: 1) process related defect - wrap not dosed with brine solution; 2) process related defect - pouch leak allows air to get into the pouch; over time the wrap will expire.This defect can be caused by the following: a) pouch leak related to an insufficient seal, or b) pouch leak due to a hole in the pouch film, or 3) other - pouch leak due to consumer mishandling that could cause the pouch to open or tear prior to use.The thermal data for the batch was reviewed and there were no thermal results outside the required specifications.A wrap not dosed with brine solution is highly unlikely; this defect if ongoing during manufacturing would be detected through the manufacturing attribute test and would be detected in the thermal testing (cold wraps).If the wraps' heat cells are not hard and are soft in nature, this would indicate brine solution was not present.To confirm a wrap with no brine solution added requires the wrap for evaluation unless the consumer indicates the heat cells or wrap was hard (not mentioned in the intake information).Process related pouch leak defects are difficult to determine once the pouch has been opened.The pti data for the batch was reviewed and there were no leak results outside the in process testing limits.The alleged defective wraps have not been received from the consumer for evaluation.Pouch leaks are considered a major attribute.Testing is performed on four pouched wraps every ten minutes of flow wrapper uptime (per spec-23451; effective date: 28-nov-2016) to minimize the occurrence of defective pouches in the batch.Maximum acceptable pouch leak fails are based on the number of the performed sample tests.(b)(4) equipment was added to the flow wrapper in jan-2017.It monitors the s.

• 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: 9257852
• MDR Text Key: 181963504
• Report Number: 1066015-2019-00282
• 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
• Report Date: 09/18/2017

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 Date: 01/01/2020
• Device Lot Number: S23241
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/30/2019
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 60 YR