MAUDE Adverse Event Report: PFIZER CONSUMER HEALTH CARE THERMACARE HEATWRAP; DISPOSABLE PACK, HOT

Lot Number S87383

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Erythema (1840); Swelling (2091); Partial thickness (Second Degree) Burn (2694)

Event Date 12/27/2018

Event Type  Injury  

Event Description

Event verbatim [preferred term] burns at the application site/burns/blister development and severe redness on the back [burns second degree].Case narrative: this is a spontaneous report from a contactable unspecified healthcare professional.A (b)(6)-years-old female patient started to receive thermacare heatwrap (thermacare heatwrap) (device lot number s87383, expiration date mar2020), via transdermal from an unspecified date at an unspecified dose for muscle tension.The patient medical history was not reported.There were no concomitant medications.No other medications have been administered at the time of the event.The patient never administered before.The patient experienced burns at the application site after application of the product.It was reported that "the burns have been shown to us by photo and were significant." the patient experienced burns on (b)(6) 2018.The event was described as blister development and severe redness on the back.An operation was not necessary, whether another treatment was necessary was unknown.It was unknown whether the patient would experience any lasting damage.The action taken in response to the events for thermacare heatwrap and outcome of the events were unknown.Follow-up ((b)(6) 2019): new information received from the same contactable healthcare professional included: patient age, suspect product details (including route of administration and indication), no concomitant medications, reaction data (including event details, event updated to burn blister, event onset date).This medical device report is upgrade to a serious and reportable mdr.No follow-up attempts are needed.No further information expected.Company clinical evaluation comment: based on the information provided, the event of burns second degree as described are considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.The event is medically assessed as associated with the use of the device., comment: based on the information provided, the event of burns second degree as described are considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.The event is medically assessed as associated with the use of the device.

Event Description

Event verbatim [preferred term] burns at the application site/burns/blister development and severe redness on the back [burns second degree] ,.Case narrative:this is a spontaneous report from a contactable unspecified healthcare professional.A 30-year-old female patient started to receive thermacare heatwrap (thermacare heatwrap) (device lot number s87383, expiration date mar2020) via transdermal from an unspecified date at an unspecified dose for muscle tension.The patient's medical history was not reported.There were no concomitant medications.No other medications have been administered at the time of the event.The patient never administered before.The patient experienced burns at the application site after application of the product.It was reported that "the burns have been shown to us by photo and were significant." the patient experienced burns on (b)(6) 2018.The event was described as blister development and severe redness on the back.An operation was not necessary, whether another treatment was necessary was unknown.It was unknown whether the patient would experience any lasting damage.Action taken in response to the events for thermacare heatwrap and outcome of the events were unknown.Additional information received from product quality complaint (pqc) group included investigation results.The root cause category is non assignable (complaint not confirmed as quality defect).After a review of the batch thermal records, thermal results all met product release criteria.Sample is not available to confirm a defect.The consumer reported a "heat wrap caused burned blisters on the skin." the cause of the heat wrap causing "burned blisters on the skin" is inconclusive since it is not clear what caused a device malfunction.The 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, following all safety and use information as provided with the wrap to any avoid the risks.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.Batch s87383 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.The device history record (dhr), reserved samples, and trending were evaluated.No quality issues were identified.Results of product quality investigation for lot number s87383: severity of harm: s3.Summary of investigation: conclusion: based on the complaint narrative, the patient sustained a burn injuries with product use.Review of complaint description concludes there is no device malfunction.Follow-up (b)(6)2019): new information received from the same contactable healthcare professional included: patient age, suspect product details (including route of administration and indication), no concomitant medications, reaction data (including event details, event updated to burn blister, event onset date).This medical device report is upgrade to a serious and reportable mdr.Follow-up (b)(6)2019): new information received from product quality complaints (pqc) group included: product quality investigation results.Follow-up (b)(6)2019): new information received from product quality complaints (pqc) group included: severity of harm, summary of investigation.No follow-up attempts are needed.No further information expected.Company clinical evaluation comment: based on the information provided, the event of burns second degree as described are considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.The event is 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.No remedial action/corrective action/field safety corrective action is suggested at this time., comment: based on the information provided, the event of burns second degree as described are considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.The event is 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.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 as quality defect).After a review of the batch thermal records, thermal results all met product release criteria.Sample is not available to confirm a defect.The consumer reported a "heat wrap caused burned blisters on the skin." the cause of the heat wrap causing "burned blisters on the skin" is inconclusive since it is not clear what caused a device malfunction.The 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, following all safety and use information as provided with the wrap to any avoid the risks.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.Batch s87383 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.The device history record (dhr), reserved samples, and trending were evaluated.No quality issues were identified.Results of product quality investigation for lot number s87383: severity of harm: s3.Summary of investigation: conclusion: based on the complaint narrative, the patient sustained a burn injuries with product use.Review of complaint description concludes there is no device malfunction.

Manufacturer Narrative

The root cause category is non assignable (complaint not confirmed as quality defect).After a review of the batch thermal records, thermal results all met product release criteria.Sample is not available to confirm a defect.The consumer reported a "heat wrap caused burned blisters on the skin." the cause of the heat wrap causing "burned blisters on the skin" is inconclusive since it is not clear what cause a device malfunction.The 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, following all safety and use information as provided with the wrap to any avoid the risks.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.Batch s87383 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.The device history record (dhr), reserved samples, and trending were evaluated.No quality issues were identified.

Event Description

Burns at the application site/burns/blister development and severe redness on the back [burns second degree].Case narrative: this is a spontaneous report from a contactable unspecified healthcare professional.A 30-year-old female patient started to receive thermacare heatwrap (thermacare heatwrap) (device lot number s87383, expiration date mar2020) via transdermal from an unspecified date at an unspecified dose for muscle tension.The patient's medical history was not reported.There were no concomitant medications.No other medications have been administered at the time of the event.The patient never administered before.The patient experienced burns at the application site after application of the product.It was reported that "the burns have been shown to us by photo and were significant." the patient experienced burns on (b)(6) 2018.The event was described as blister development and severe redness on the back.An operation was not necessary, whether another treatment was necessary was unknown.It was unknown whether the patient would experience any lasting damage.Action taken in response to the events for thermacare heatwrap and outcome of the events were unknown.Additional information received from product quality complaint (pqc) group included investigation results.The root cause category is non assignable (complaint not confirmed as quality defect).After a review of the batch thermal records, thermal results all met product release criteria.Sample is not available to confirm a defect.The consumer reported a "heat wrap caused burned blisters on the skin." the cause of the heat wrap causing "burned blisters on the skin" is inconclusive since it is not clear what caused a device malfunction.The 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, following all safety and use information as provided with the wrap to any avoid the risks.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.Batch s87383 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.The device history record (dhr), reserved samples, and trending were evaluated.No quality issues were identified.Follow-up (27feb2019): new information received from the same contactable healthcare professional included: patient age, suspect product details (including route of administration and indication), no concomitant medications, reaction data (including event details, event updated to burn blister, event onset date).This medical device report is upgrade to a serious and reportable mdr.Follow-up (07oct2019): new information received from product quality complaints (pqc) group included: product quality investigation results.No follow-up attempts are needed.No further information expected.Company clinical evaluation comment: based on the information provided, the event of burns second degree as described are considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.The event is 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.No remedial action/corrective action/field safety corrective action is suggested at this time.Comment: based on the information provided, the event of burns second degree as described are considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.The event is 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.No remedial action/corrective action/field safety corrective action is suggested at this time.

• Brand Name: THERMACARE HEATWRAP
• Type of Device: DISPOSABLE PACK, HOT
• Manufacturer (Section D): PFIZER CONSUMER HEALTH CARE; 1231 wyandotte drive; albany GA 31705
• MDR Report Key: 8396119
• MDR Text Key: 138072982
• Report Number: 1066015-2019-00056
• 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: foreign,health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 01/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/01/2020
• Device Lot Number: S87383
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 30 YR