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

Lot Number W03753

Device Problems Patient-Device Incompatibility (2682); Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191)

Patient Problem Burn, Thermal (2530)

Event Type  Injury  

Event Description

Applied the product for 8 hours and her lower back got burned,her skin was now peeling off [burns second degree] ,.Case narrative:this is a spontaneous report from a contactable consumer via call centre.A female patient of an unspecified age started to receive thermacare heatwrap (thermacare lower back & hip) on an unspecified date for an unspecified indication.Relevant medical history and concomitant medications were not reported.On an unspecified date the patient applied the product for 8 hours and her lower back got burned, her skin was now peeling off.The action taken in response to the events for thermacare heatwrap was unknown.The outcome of the events was unknown.Additional information has been requested and will be provided as it becomes available.Comment: based on the information provided, the event of "lower back got burned, her skin was now peeling off" as described is considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.A causal relationship between the device and event cannot be ruled out.

Event Description

Event verbatim [preferred term] applied the product for 8 hours and her lower back got burned,her skin was now peeling off [burns second degree] ,.Case narrative:this is a spontaneous report from a contactable consumer via call centre.A female patient of an unspecified age started to receive thermacare heatwrap (thermacare lower back & hip) on an unspecified date for an unspecified indication.Relevant medical history and concomitant medications were not reported.On an unspecified date the patient applied the product for 8 hours and her lower back got burned, her skin was now peeling off.The action taken in response to the events for thermacare heatwrap was unknown.The outcome of the events was unknown.Product quality complaints (pqc) group reported: reasonably suggest device malfunction: yes, severity of harm: s3.Additional information has been requested and will be provided as it becomes available.Follow-up ((b)(6) 2020): new information reported from the product quality complaints group includes: manufacturing site severity and malfunction assessment provided., comment: based on the information provided, the event of "lower back got burned, her skin was now peeling off" as described is considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.A causal relationship between the device and event cannot be ruled out.

Event Description

Event verbatim [preferred term].Applied the product for 8 hours and her lower back got burned,her skin was now peeling off [thermal burn].Narrative: this is a spontaneous report from a contactable consumer via call centre.A female patient of an unspecified age started to receive thermacare heatwrap (thermacare lower back & hip) on an unspecified date for an unspecified indication.Device lot number w03753 and expiry date nov2020.Relevant medical history and concomitant medications were not reported.On an unspecified date the patient applied the product for 8 hours and her lower back got burned, her skin was now peeling off.The action taken in response to the events for thermacare heatwrap was unknown.The outcome of the events was unknown.A sample of the product was available to be returned (not yet collected as of 16apr2020 follow-up).Product quality complaints (pqc) group reported: reasonably suggest device malfunction: yes, severity of harm: s3.Additional information has been requested and will be provided as it becomes available.Follow-up (23mar2020): new information reported from the product quality complaints group includes: manufacturing site severity and malfunction assessment provided.Follow-up (16apr2020 and 20apr2020): new information from the same contactable reporter includes: sample status (available for return) and product lot/ expiry.Additionally, this follow-up is being submitted to amend the following previously reported information: event information (updated to "burn of unspecified degree of back any part").Comment: based on the information provided, the event of "applied the product for 8 hours and her lower back got burned, her skin was now peeling off" as described is considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.A causal relationship between the device and event cannot be ruled out.

Event Description

Event verbatim [preferred term].Applied the product for 8 hours and her lower back got burned,her skin was now peeling off [thermal burn].Narrative: this is a spontaneous report from a contactable consumer via call centre.A female patient of an unspecified age started to receive thermacare heatwrap (thermacare lower back & hip) on an unspecified date for an unspecified indication.Device lot number w03753 and expiry date nov2020.Relevant medical history and concomitant medications were not reported.On an unspecified date the patient applied the product for 8 hours and her lower back got burned, her skin was now peeling off.The action taken in response to the events for thermacare heatwrap was unknown.The outcome of the events was unknown.A sample of the product was available to be returned (not yet collected as of 16apr2020 follow-up).Product quality complaints (pqc) group reported: reasonably suggest device malfunction: yes, severity of harm: s3.The following investigation results were reported: a full investigation is not required, complaint not confirmed.This investigation was conducted for an unknown lot number lower back/hip (lbh) 8-hour product.There was limited device specific information provided, no batch number or return sample was available for evaluation.Without a batch reference number and /or return sample a manufacturing and technical evaluation cannot be completed for the wrap involved in this case.There is not a trend identified related for the subclass adverse event/serious/unknown.Follow-up (23mar2020): new information reported from the product quality complaints group includes: manufacturing site severity and malfunction assessment provided.Follow-up (16apr2020 and 20apr2020): new information from the same contactable reporter includes: sample status (available for return) and product lot/ expiry.Additionally, this follow-up is being submitted to amend the following previously reported information: event information (updated to "burn of unspecified degree of back any part").Follow-up (22apr2020): new information from product quality complaints includes investigation results.Comment: based on the information provided, the event of "applied the product for 8 hours and her lower back got burned, her skin was now peeling off" as described is considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.A causal relationship between the device and event cannot be ruled out.

Manufacturer Narrative

A full investigation is not required, complaint not confirmed.This investigation was conducted for an unknown lot number lower back/hip (lbh) 8-hour product.There was limited device specific information provided, no batch number or return sample was available for evaluation.Without a batch reference number and /or return sample a manufacturing and technical evaluation cannot be completed for the wrap involved in this case.There is not a trend identified related for the subclass adverse event/serious/unknown.

Manufacturer Narrative

The root cause category is non assignable (complaint not confirmed as a quality defect).A return sample is not available at the site for evaluation.After a review of the batch thermal records, thermal results all met product release criteria.Consumer reports the wrap caused "burned her skin ".The cause of the consumer stating the wrap caused burned her skin is inconclusive since review of records does not provide evidence to support 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 batchrecords, 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.

Event Description

Event verbatim [preferred term].Applied the product for 8 hours and her lower back got burned,her skin was now peeling off [thermal burn], , narrative: this is a spontaneous report from a contactable consumer via call centre.A female patient of an unspecified age started to receive thermacare heatwrap (thermacare lower back & hip) on an unspecified date for an unspecified indication.Device lot number w03753 and expiry date nov2020.Relevant medical history and concomitant medications were not reported.On an unspecified date the patient applied the product for 8 hours and her lower back got burned, her skin was now peeling off.The action taken in response to the event for thermacare heatwrap was unknown.The outcome of the event was unknown.A sample of the product was available to be returned (not yet collected as of 16apr2020 follow-up).Product quality complaints (pqc) group reported: reasonably suggest device malfunction: yes, severity of harm: s3.The following investigation results were reported: a full investigation is not required, complaint not confirmed.This investigation was conducted for an unknown lot number lower back/hip (lbh) 8-hour product.There was limited device specific information provided, no batch number or return sample was available for evaluation.Without a batch reference number and /or return sample a manufacturing and technical evaluation cannot be completed for the wrap involved in this case.There is not a trend identified related for the subclass adverse event/serious/unknown.Additional information from the product quality group includes: the root cause category is non assignable (complaint not confirmed as a quality defect).A return sample is not available at the site for evaluation.After a review of the batch thermal records, thermal results all met product release criteria.Consumer reports the wrap caused "burned her skin ".The cause of the consumer stating the wrap caused burned her skin is inconclusive since review of records does not provide evidence to support 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, 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 (23mar2020): new information reported from the product quality complaints group includes: manufacturing site severity and malfunction assessment provided.Follow-up (16apr2020 and 20apr2020): new information from the same contactable reporter includes: sample status (available for return) and product lot/ expiry.Additionally, this follow-up is being submitted to amend the following previously reported information: event information (updated to "burn of unspecified degree of back (any part)").Follow-up (22apr2020): new information from product quality complaints includes investigation results.Follow-up (15sep2020): new information from product quality complaints includes: additional investigation results.

Manufacturer Narrative

Summary of investigation: batch w03753 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.The device history record (dhr), and trending were evaluated.No quality issues were identified.Conclusion: the root cause category is non assignable (complaint not confirmed as a quality defect).A return sample is not available at the site for evaluation.After a review of the batch thermal records, thermal results all met product release criteria.Consumer reports the wrap caused "burned her skin ".The cause of the consumer stating the wrap caused burned her skin is inconclusive since review of records does not provide evidence to support 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, 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.Lot trend assmt.& rationale: lot trend actions taken: an evaluation of the complaint history confirms that this is the a trend does not exist for this batch 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 requiring investigation by the site.Exped trend actions taken: based on this citi search, there is not a trend identified for the subclass of adverse event/serious/unknown.Refer to the 36-month trending chart attachment lbh adverse event-serious-unknown (b)(6) 2020.There was deviation from sop-105746, complaint trending guidelines, effective 24-feb-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-(b)(4) action item pr-(b)(4).

Event Description

Applied the product for 8 hours and her lower back got burned,her skin was now peeling off [thermal burn], narrative: this is a spontaneous report from a contactable consumer via call centre.A female patient of an unspecified age started to receive thermacare heatwrap (thermacare lower back & hip) on an unspecified date for an unspecified indication.Device lot number w03753 and expiry date nov2020.Relevant medical history and concomitant medications were not reported.On an unspecified date the patient applied the product for 8 hours and her lower back got burned, her skin was now peeling off.The action taken in response to the event for thermacare heatwrap was unknown.The outcome of the event was unknown.A sample of the product was available to be returned (not yet collected as of 16apr2020 follow-up).Product quality complaints (pqc) group reported: reasonably suggest device malfunction: yes, severity of harm: s3.The following investigation results were reported: a full investigation is not required, complaint not confirmed.This investigation was conducted for an unknown lot number lower back/hip (lbh) 8-hour product.There was limited device specific information provided, no batch number or return sample was available for evaluation.Without a batch reference number and /or return sample a manufacturing and technical evaluation cannot be completed for the wrap involved in this case.There is not a trend identified related for the subclass adverse event/serious/unknown.Additional information from the product quality group includes: summary of investigation: batch w03753 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.The device history record (dhr), and trending were evaluated.No quality issues were identified.Conclusion: the root cause category is non assignable (complaint not confirmed as a quality defect).A return sample is not available at the site for evaluation.After a review of the batch thermal records, thermal results all met product release criteria.Consumer reports the wrap caused "burned her skin ".The cause of the consumer stating the wrap caused burned her skin is inconclusive since review of records does not provide evidence to support 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, 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.Lot trend assmt.& rationale: lot trend actions taken: an evaluation of the complaint history confirms that this is the a trend does not exist for this batch 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 requiring investigation by the site.Exped trend actions taken: based on this citi search, there is not a trend identified for the subclass of adverse event/serious/unknown.Refer to the 36-month trending chart lbh adverse event-serious-unknown b)(4) 2020.There was deviation from sop-105746, complaint trending guidelines, effective 24-feb-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-(b)(4), action item pr-b)(4).Follow-up (23mar2020): new information reported from the product quality complaints group includes: manufacturing site severity and malfunction assessment provided.Follow-up (16apr2020 and 20apr2020): new information from the same contactable reporter includes: sample status (available for return) and product lot/ expiry.Additionally, this follow-up is being submitted to amend the following previously reported information: event information (updated to "burn of unspecified degree of back (any part)").Follow-up (22apr2020): new information from product quality complaints includes investigation results.Follow-up (15sep2020): new information from product quality complaints includes: additional investigation results.Follow-up (14oct2020): new information from product quality complaints includes: updated trend information.

• 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: 9884607
• MDR Text Key: 189151799
• Report Number: 1066015-2020-00084
• 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,other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 03/16/2020

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: 11/01/2020
• Device Lot Number: W03753
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/26/2020
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 04/08/2020; 04/29/2020; 04/30/2020; 09/30/2020; 10/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention