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

Device Problem Leak/Splash (1354)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

Thermacare broke and the contents got on a blanket [device leakage].Case description: this is a spontaneous report from a contactable non-healthcare professional.A patient of unspecified age and gender started to use thermacare heatwrap (thermacare heatwrap) from an unspecified date for an unspecified indication.The patient medical history and concomitant medications were not reported.The reporter was at the laundromat and he had a customer who's thermacare broke and the contents got on a blanket.He wanted to know how to wash it.Complainant does not have the product with them at the time of call.The action taken with thermacare heatwrap and the outcome of the event were unknown.No follow-up attempts needed.No further information expected.Follow-up (09jun2016): this follow-up report is being submitted to upgrade this case to a reportable mdr.Company clinical evaluation comment: the event "thermacare broke and the contents got on a blanket" (device leakage) was assessed as non-serious.No other adverse event was associated with the use of the device.This is a single potential device malfunction has a theoretical risk to cause skin burn.The event was assessed as associated with the use of the device.

Event Description

Event verbatim [preferred term] thermacare broke and the contents got on a blanket [device leakage].Case narrative:this is a spontaneous report from a contactable consumer.A patient of unspecified age and gender started to use thermacare heatwrap (thermacare heatwrap) from an unspecified date for an unspecified indication.The patient medical history and concomitant medications were not reported.The reporter was at the laundromat and he had a customer who's thermacare broke and the contents got on a blanket.He wanted to know how to wash it.Complainant does not have the product with them at the time of call.The action taken with thermacare heatwrap and the outcome of the event were unknown.According to the product quality complaint group: reasonably suggest device malfunction was yes and severity of harm was s3 for complaint sub-class: heat cells damaged/leaking.There is reasonable suspicion of a device malfunction.The impact is cell leakage and the severity is s3-skin burn- per rpt- # hazard analysis thermacare heat wrap product: 8 and 12 hour.Additional information has been requested and will be provided as it becomes available.Follow-up (09jun2016): this follow-up report is being submitted to upgrade this case to a reportable mdr.Follow-up (13nov2019 and 14nov2019): new information received from a contactable consumer and the product quality complaint group includes new reporter added, severity rating and malfunction assessment.Follow-up attempts are completed.No further information is expected.Follow-up (13nov2019): new information received from a product quality complaint group included: impact analysis and severity rating.Company clinical evaluation comment the event "thermacare broke and the contents got on a blanket" (device leakage) was assessed as non-serious.No other adverse event was associated with the use of the device.This is a single potential device malfunction has a theoretical risk to cause skin burn.The event was assessed as associated with the use of the device., comment: the event "thermacare broke and the contents got on a blanket" (device leakage) was assessed as non-serious.No other adverse event was associated with the use of the device.This is a single potential device malfunction has a theoretical risk to cause skin burn.The event was assessed as associated with the use of the device.

Event Description

Event verbatim [preferred term] thermacare broke and the contents got on a blanket [device leakage].Case narrative:this is a spontaneous report from a contactable consumer.A patient of unspecified age and gender started to use thermacare heatwrap (thermacare heatwrap) from an unspecified date for an unspecified indication.The patient medical history and concomitant medications were not reported.The reporter was at the laundromat and he had a customer who's thermacare broke and the contents got on a blanket.He wanted to know how to wash it.Complainant does not have the product with them at the time of call.The action taken with thermacare heatwrap and the outcome of the event were unknown.According to the product quality complaint group: reasonably suggest device malfunction was yes and severity of harm was s3 for complaint sub-class: heat cells damaged/leaking.Additional information has been requested and will be provided as it becomes available.Follow-up (09jun2016): this follow-up report is being submitted to upgrade this case to a reportable mdr.Follow-up (13nov2019 and 14nov2019): new information received from a contactable consumer and the product quality complaint group includes new reporter added, severity rating and malfunction assessment.Follow-up attempts are completed.No further information is expected.Company clinical evaluation comment: the event "thermacare broke and the contents got on a blanket" (device leakage) was assessed as non-serious.No other adverse event was associated with the use of the device.This is a single potential device malfunction has a theoretical risk to cause skin burn.The event was assessed as associated with the use of the device., comment: the event "thermacare broke and the contents got on a blanket" (device leakage) was assessed as non-serious.No other adverse event was associated with the use of the device.This is a single potential device malfunction has a theoretical risk to cause skin burn.The event was assessed as associated with the use of the device.

Event Description

Event verbatim [preferred term] thermacare broke and the contents got on a blanket [device leakage].Case narrative:this is a spontaneous report from a contactable consumer.A patient of unspecified age and gender started to use thermacare heatwrap (thermacare heatwrap) from an unspecified date for an unspecified indication.The patient medical history and concomitant medications were not reported.The reporter was at the laundromat and he had a customer who's thermacare broke and the contents got on a blanket.He wanted to know how to wash it.Complainant does not have the product with them at the time of call.The action taken with thermacare heatwrap and the outcome of the event were unknown.According to the product quality complaint group: reasonably suggest device malfunction was yes and severity of harm was s3 for complaint sub-class: heat cells damaged/leaking.There is reasonable suspicion of a device malfunction.The impact is cell leakage and the severity is s3-skin burn- per hazard analysis thermacare heat wrap product: 8 and 12 hour.Summary of investigation: this investigation was conducted for an unknown lot number lower back/hip (lbh) 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 product quality related trend identified for the subclass heat cells damaged/leaking.Regulatory impact: no.Process related?: no.Final confirmation status: not confirmed.Product quality impact: no.Market / clinical impact: no.Stability impact: no.Conclusion: the root cause category is non-assignable (complaint not confirmed as a quality defect).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 product quality related trend identified for the subclass heat cells damaged/leaking.The 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.Document review summary: there is no device history report (dhr) reviewed for an unknown batch number.Reserve sample evaluation and test required: no.Lot-specific trend identified?: no.Expedite trend identified?: no.Exped trend assessment and rationale: an evaluation was made by searching for possible trends for this subclass.The following complaint intake, triage and investigation (citi) search was performed: scope: date of contact: 09jun2013 through 09jun2016/manufacturing site: (site)/complaint class: product appearance /complaint sub class: heat cells damaged/leaking and cells damaged/leaking.The citi customizable search returned a total of 51 complaint for lower back and hip 8hr products during this time period for the class/subclass.5 of the 51 complaints were confirmed as having a manufacturing related root cause of the wrap having heat cells/ damaged/ leaking and cells damaged/leaking.Based on this citi search, there is not a trend identified for the subclass cells damaged/leaking and heat cells damaged/leaking for lbh 8hr products, 09jun2013 to 09jun2016.No further action is required.Other trend identified?: no.(parent) sample status: sample availability unknown.Site sample status: not received.Follow-up (09jun2016): this follow-up report is being submitted to upgrade this case to a reportable mdr.Follow-up (13nov2019 and 14nov2019): new information received from a contactable consumer and the product quality complaint group includes new reporter added, severity rating and malfunction assessment.Follow-up attempts are completed.No further information is expected.Follow-up (13nov2019): new information received from a product quality complaint group included: impact analysis and severity rating.Follow up (18nov2019): new information received from a product quality complaint group included: summary of investigation, conclusion and other investigation findings.Follow-up attempts are completed.No further information is expected.Company clinical evaluation comment: the event "thermacare broke and the contents got on a blanket" (device leakage) was assessed as non-serious.No other adverse event was associated with the use of the device.This is a single potential device malfunction has a theoretical risk to cause skin burn.The event was assessed as associated with the use of the device.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.Product effect varies with each individual.No remedial action/corrective action/field safety corrective action is suggested at this time., comment: the event "thermacare broke and the contents got on a blanket" (device leakage) was assessed as non-serious.No other adverse event was associated with the use of the device.This is a single potential device malfunction has a theoretical risk to cause skin burn.The event was assessed as associated with the use of the device.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.Product effect varies with each individual.No remedial action/corrective action/field safety corrective action is suggested at this time.

Manufacturer Narrative

Reasonably suggest device malfunction was yes and severity of harm was s3 for complaint sub-class: heat cells damaged/leaking.There is reasonable suspicion of a device malfunction.The impact is cell leakage and the severity is s3-skin burn- per hazard analysis thermacare heat wrap product: 8 and 12 hour.Summary of investigation: this investigation was conducted for an unknown lot number lower back/hip (lbh) 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 product quality related trend identified for the subclass heat cells damaged/leaking.Regulatory impact: no.Process related?: no.Final confirmation status: not confirmed.Product quality impact: no.Market / clinical impact: no.Stability impact: no.Conclusion: the root cause category is non-assignable (complaint not confirmed as a quality defect).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 product quality related trend identified for the subclass heat cells damaged/leaking.The 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.Document review summary: there is no device history report (dhr) reviewed for an unknown batch number.Reserve sample evaluation and test required: no.Lot-specific trend identified?: no.Expedite trend identified?: no.Exped trend assessment and rationale: an evaluation was made by searching for possible trends for this subclass.The following complaint intake, triage and i.

• 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: 9263825
• MDR Text Key: 220010420
• Report Number: 1066015-2019-00308
• 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: 06/09/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/09/2016
• Initial Date FDA Received: 10/31/2019
• Supplement Dates Manufacturer Received: 06/09/2016; 06/09/2016; 06/09/2016
• Supplement Dates FDA Received: 11/20/2019; 11/22/2019; 12/02/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1