MAUDE Adverse Event Report: THERMACARE LOWER BACK & HIP; DISPOSABLE PACK, HOT

Lot Number DC9524

Device Problem Use of Device Problem (1670)

Patient Problems Abrasion (1689); Skin Tears (2516)

Event Date 05/02/2020

Event Type  malfunction  

Event Description

Her skin came off [skin exfoliation], the area where the skin came off is a abrasion at this point [skin abrasion], purchased the thermacare lower back and hip heatwraps for her daughter that had menstrual pain [device use issue], , narrative: this is a spontaneous report from a contactable consumer reporting for her daughter.A (b)(6) year-old female patient started to use thermacare heatwrap (thermacare lower back & hip), device lot number dc9524, expiration date sep2022, upc#: (b)(4), topically on (b)(6) 2020 at 1 application for 8 hours for pain menstrual.Medical history and concomitant medications were none.There was no investigation assessment.The reporter stated that she purchased the thermacare lower back and hip heatwraps for her daughter that had menstrual pain.She said that she got the product for her daughter and when she tried to take off the heatwrap, it removed her skin and her skin came off with the thermacare heatwrap on (b)(6) 2020.The reporter said that the area where the skin came off was a abrasion at this point in (b)(6) 2020.The product was available for evaluation.It was reported there was no permanent impairment/damage of a body structure/function (disability) and no medical or surgical intervention to prevent permanent impairment/damage to a body function/structure (serious injury) was required.The last action taken in response to the events for thermacare heatwrap was permanently withdrawn on (b)(6) 2020.The treatment for the event skin came off included left the area open to air.She stated that it was just raw skin.The outcome of the event "her skin came off" was recovering, of the other events was unknown.Additional information has been requested and will be provided as it becomes available.

Manufacturer Narrative

Summary of investigation: batch dc9524 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 the wrap "removed her skin and her skin came off".The cause of the consumer stating the wrap removed her daughter's skin and her skin came off is inconclusive since the review of records does not provide evidence to support defective products.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, 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.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 for this batch.On the basis of this evaluation, a trend does not exist for this batch.Exped trend assmt.& rationale: an evaluation was made by searching for possible trends for this subclass.Exped trend actions taken: based on this citi customizable search for the subclasses of adverse event serious/unknown for lbh products the data did not show an increase over time (24 months).There is not a trend identified for the subclass of adverse event serious/unknown for lbh product.Site sample status was not received.Severity of harm was provided as s3.

Event Description

Her skin came off [skin exfoliation].The area where the skin came off is a abrasion at this point [skin abrasion], purchased the thermacare lower back and hip heatwraps for her daughter that had menstrual pain [device use issue].Narrative: this is a spontaneous report from a contactable consumer reporting for her daughter.A 24-year-old female patient started to use thermacare heatwrap (thermacare lower back & hip), device lot number dc9524, expiration date sep2022, upc#: 0573301003, topically on (b)(6) 2020 at 1 application for 8 hours for pain menstrual.Medical history and concomitant medications were none.There was no investigation assessment.The reporter stated that she purchased the thermacare lower back and hip heatwraps for her daughter that had menstrual pain.She said that she got the product for her daughter and when she tried to take off the heatwrap, it removed her skin and her skin came off with the thermacare heatwrap on (b)(6) 2020.The reporter said that the area where the skin came off was a abrasion at this point in (b)(6) 2020.The product was available for evaluation.It was reported there was no permanent impairment/damage of a body structure/function (disability) and no medical or surgical intervention to prevent permanent impairment/damage to a body function/structure (serious injury) was required.The last action taken in response to the events for thermacare heatwrap was permanently withdrawn on (b)(6) 2020.The treatment for the event skin came off included left the area open to air.She stated that it was just raw skin.The outcome of the event "her skin came off" was recovering, of the other events was unknown.According to the product quality complaint group: summary of investigation: batch dc9524 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 the wrap "removed her skin and her skin came off".The cause of the consumer stating the wrap removed her daughter's skin and her skin came off is inconclusive since the review of records does not provide evidence to support defective products.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, 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.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 for this batch.On the basis of this evaluation, a trend does not exist for this batch.Exped trend assmt.& rationale: an evaluation was made by searching for possible trends for this subclass.Exped trend actions taken: based on this citi customizable search for the subclasses of adverse event serious/unknown for lbh products the data did not show an increase over time (24 months).There is not a trend identified for the subclass of adverse event serious/unknown for lbh product.Site sample status was not received.Severity of harm was provided as s3.Follow-up(15may2020):follow-up attempts are completed.No further information is expected.Follow-up (31jul2020): new information received from the product quality complaint group included investigational results.Follow-up attempts are completed.No further information is expected.

Event Description

Event verbatim [preferred term] her skin came off [skin exfoliation], the area where the skin came off is a abrasion at this point [skin abrasion], purchased the thermacare lower back and hip heatwraps for her daughter that had menstrual pain [device use issue].Narrative: this is a spontaneous report from a contactable consumer reporting for her daughter.A 24-year-old female patient started to use thermacare heatwrap (thermacare lower back & hip), device lot number dc9524, expiration date 30sep2022, upc#: 0573301003, topically on (b)(6) 2020 at 1 application for 8 hours for pain menstrual.Medical history and concomitant medications were none.There was no investigation assessment.The reporter stated that she purchased the thermacare lower back and hip heatwraps for her daughter that had menstrual pain.She said that she got the product for her daughter and when she tried to take off the heatwrap, it removed her skin and her skin came off with the thermacare heatwrap on (b)(6) 2020.The reporter said that the area where the skin came off was a abrasion at this point in (b)(6) 2020.The product was available for evaluation.It was reported there was no permanent impairment/damage of a body structure/function (disability) and no medical or surgical intervention to prevent permanent impairment/damage to a body function/structure (serious injury) was required.The last action taken in response to the events for thermacare heatwrap was permanently withdrawn on (b)(6) 2020.The treatment for the event skin came off included left the area open to air.She stated that it was just raw skin.The outcome of the event "her skin came off" was recovering, of the other events was unknown.According to the product quality complaint group: summary of investigation: batch dc9524 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 the wrap "removed her skin and her skin came off".The cause of the consumer stating the wrap removed her daughter's skin and her skin came off is inconclusive since the review of records does not provide evidence to support defective products.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, 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.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 for this batch.On the basis of this evaluation, a trend does not exist for this batch.Exped trend assmt.& rationale: an evaluation was made by searching for possible trends for this subclass.Exped trend actions taken: based on this citi customizable search for the subclasses of adverse event serious/unknown for lbh products the data did not show an increase over time (36 months).There is not a trend identified for the subclass of adverse event serious/unknown for lbh product.The expedite trending of complaint investigations was trended for a 24-month period instead of a 36-month period.This investigation was reopened to correct the trending.The results do not change the root cause of the complaint.Corrections will be completed in pr-#, action item pr-#.Site sample status was not received.Severity of harm was provided as s3.Follow-up(15may2020):follow-up attempts are completed.No further information is expected.Follow-up (31jul2020): new information received from the product quality complaint group included investigational results.Follow-up attempts are completed.No further information is expected.Follow-up (12oct2020): new information reported from product quality complaints included: updated trend information.Follow-up attempts are completed.No further information is expected.Amendment: this follow-up report is being submitted to amend previously reported information: malfunction was checked as yes and intervention required was unchecked.

Manufacturer Narrative

Summary of investigation: batch dc9524 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 the wrap "removed her skin and her skin came off".The cause of the consumer stating the wrap removed her daughter's skin and her skin came off is inconclusive since the review of records does not provide evidence to support defective products.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, 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.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 for this batch.On the basis of this evaluation, a trend does not exist for this batch.Exped trend assmt.& rationale: an evaluation was made by searching for possible trends for this subclass.Exped trend actions taken: based on this citi customizable search for the subclasses of adverse event serious/unknown for lbh products the data did not show an increase over time (36 months).There is not a trend identified for the subclass of adverse event serious/unknown for lbh product.The expedite trending of complaint investigations was trended for a 24-month period instead of a 36-month period.This investigation was reopened to correct the trending.The results do not change the root cause of the complaint.Corrections will be completed in pr-#, action item pr-#.Site sample status was not received.Severity of harm was provided as s3.

Manufacturer Narrative

Summary of investigation: batch dc9524 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 the wrap "removed her skin and her skin came off".The cause of the consumer stating the wrap removed her daughter's skin and her skin came off is inconclusive since the review of records does not provide evidence to support defective products.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, 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.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 for this batch.On the basis of this evaluation, a trend does not exist for this batch.Exped trend assmt.& rationale: an evaluation was made by searching for possible trends for this subclass.Exped trend actions taken: based on this citi customizable search for the subclasses of adverse event serious/unknown for lbh products the data did not show an increase over time (36 months).There is not a trend identified for the subclass of adverse event serious/unknown for lbh product, refer to attachment adverse event serious unknown lbh (b)(6) 2017 to (b)(6) 2020.There was deviation from (b)(4), complaint trending guidelines, effective (b)(6) 2020 in which the expedite trending of complaint investigations was trended for a 24-month period instead of a 36-month period.This investigation was reopened to correct the trending.The results do not change the root cause of the complaint.Corrections will be completed in pr-#, action item pr-#.Site sample status was not received.Severity of harm was provided as s3.

Event Description

Event verbatim [preferred term].Her skin came off [skin exfoliation], the area where the skin came off is a abrasion at this point [skin abrasion], purchased the thermacare lower back and hip heatwraps for her daughter that had menstrual pain [device use issue], , narrative: this is a spontaneous report from a contactable consumer reporting for her daughter.A 24-year-old female patient started to use thermacare heatwrap (thermacare lower back & hip), device lot number dc9524, expiration date 30sep2022, upc#: 0573301003, topically on (b)(6) 2020 at 1 application for 8 hours for pain menstrual.Medical history and concomitant medications were none.There was no investigation assessment.The reporter stated that she purchased the thermacare lower back and hip heatwraps for her daughter that had menstrual pain.She said that she got the product for her daughter and when she tried to take off the heatwrap, it removed her skin and her skin came off with the thermacare heatwrap on (b)(6) 2020.The reporter said that the area where the skin came off was a abrasion at this point in (b)(6) 2020.The product was available for evaluation.It was reported there was no permanent impairment/damage of a body structure/function (disability) and no medical or surgical intervention to prevent permanent impairment/damage to a body function/structure (serious injury) was required.The last action taken in response to the events for thermacare heatwrap was permanently withdrawn on (b)(6) 2020.The treatment for the event skin came off included left the area open to air.She stated that it was just raw skin.The outcome of the event "her skin came off" was recovering, of the other events was unknown.According to the product quality complaint group: summary of investigation: batch dc9524 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 the wrap "removed her skin and her skin came off".The cause of the consumer stating the wrap removed her daughter's skin and her skin came off is inconclusive since the review of records does not provide evidence to support defective products.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, 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.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 for this batch.On the basis of this evaluation, a trend does not exist for this batch.Exped trend assmt.& rationale: an evaluation was made by searching for possible trends for this subclass.Exped trend actions taken: based on this citi customizable search for the subclasses of adverse event serious/unknown for lbh products the data did not show an increase over time (36 months).There is not a trend identified for the subclass of adverse event serious/unknown for lbh product, refer to attachment adverse event serious unknown lbh (b)(6) 2017 to(b)(6) 2020.There was deviation from sop-105746, complaint trending guidelines, effective (b)(6) 2020 in which the expedite trending of complaint investigations was trended for a 24-month period instead of a 36-month period.This investigation was reopened to correct the trending.The results do not change the root cause of the complaint.Corrections will be completed in pr-#, action item pr-#.Site sample status was not received.Severity of harm was provided as s3.Follow-up(15may2020):follow-up attempts are completed.No further information is expected.Follow-up (31jul2020): new information received from the product quality complaint group included investigational results.Follow-up attempts are completed.No further information is expected.Follow-up (12oct2020): new information reported from product quality complaints included: updated trend information.Follow-up attempts are completed.No further information is expected.

• Brand Name: THERMACARE LOWER BACK & HIP
• Type of Device: DISPOSABLE PACK, HOT
• MDR Report Key: 10054188
• MDR Text Key: 190912793
• Report Number: 1066015-2020-00114
• 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,Followup
• Report Date: 05/07/2020

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: 09/30/2022
• Device Lot Number: DC9524
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/13/2020
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 08/11/2020; 10/20/2020; 11/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 24 YR
• Patient Weight: 95