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

PFIZER CONSUMER HEALTH CARE THERMACARE LOWER BACK & HIP; DISPOSABLE PACK, HOT

Device Problems Nonstandard Device (1420); Overheating of Device (1437); Excessive Heating (4030)

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

Event Type malfunction

Manufacturer Narrative

Samples available: no.Sample status: not available.Severity of harm: n/a.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 adverse event safety request for investigation.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 adverse event safety request for investigation.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.Reserve sample evaluation and test required: no, unknown lot number.Lot-specific trend identified: no.A lot trend was not performed as the lot number is unknown.

Event Description

Event verbatim [preferred term] noticed a lot of the thermacare wraps were getting too hot [device issue].Case narrative:this is a spontaneous report from a non-contactable consumer.A male patient of an unspecified age started to use thermacare heatwrap (thermacare lower back & hip, lot r15312), via an unspecified route of administration from an unspecified date, for an unspecified indication.Medical history and concomitant medications were not reported.The patient gets 30 wraps a month and "a bunch of them are no good" on unknown dates.The patient received a letter that they had been recalled, and the week before he received the letter regarding the recall, he noticed a lot of the thermacare wraps were getting too hot.The action taken with thermacare heatwrap in response to the event and the outcome of the event were both unknown.On 01oct2019, product quality complaint group provided following investigation findings: samples available: no.Sample status: not available.Severity of harm: n/a.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 adverse event safety request for investigation.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 adverse event safety request for investigation.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.Reserve sample evaluation and test required: no, unknown lot number.Lot-specific trend identified: no.A lot trend was not performed as the lot number is unknown.No follow up attempts are possible; information about batch number cannot be obtained.No further information is expected.Follow up (01oct2019): new information received from a product quality complaint group includes: investigation summary and conclusion, and other investigation findings.This case was upgraded to a reportable mdr.No follow up attempts are possible.No further information is expected.Company clinical evaluation comment: the patient reported that "he noticed that a lot of the thermacare wraps were getting too hot".No adverse event was associated with the use of the device.This is a single potential device malfunction which has a theoretical risk to cause skin burn.No further investigations or actions is suggested at this time.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.No remedial action/corrective action/field safety corrective action is suggested at this time., comment: the patient reported that "he noticed that a lot of the thermacare wraps were getting too hot".No adverse event was associated with the use of the device.This is a single potential device malfunction which has a theoretical risk to cause skin burn.No further investigations or actions is suggested at this time.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.No remedial action/corrective action/field safety corrective action is suggested at this time.

Event Description

Event verbatim [preferred term] noticed a lot of the thermacare wraps were getting too hot [device issue].Case narrative:this is a spontaneous report from a non-contactable consumer.A male patient of an unspecified age started to use thermacare heatwrap (thermacare lower back & hip), via an unspecified route of administration from an unspecified date, for an unspecified indication.Medical history and concomitant medications were not reported.The patient gets 30 wraps a month and "a bunch of them are no good" on unknown dates.The patient received a letter that they had been recalled, and the week before he received the letter regarding the recall, he noticed a lot of the thermacare wraps were getting too hot.The action taken with thermacare heatwrap in response to the event and the outcome of the event were both unknown.On 01oct2019, product quality complaint group provided following investigation findings: samples available: no.Sample status: not available.Severity of harm: n/a.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 adverse event safety request for investigation.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 adverse event safety request for investigation.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.Reserve sample evaluation and test required: no, unknown lot number.Lot-specific trend identified: no.A lot trend was not performed as the lot number is unknown.Upon follow-up 05nov2019, product quality complaints provided severity of harm ranking: s3.Follow up (01oct2019): new information received from a product quality complaint group includes: investigation summary and conclusion, and other investigation findings.This case was upgraded to a reportable mdr.Amendment: this follow-up report is being submitted to amend previously reported information: lot number (did not belong to this report) removed from narrative.Follow-up (31oct2019 and 05nov2019): this case is being submitted to notify that the prior amendment information for this case was first received by the company on 31oct2019 and not on 05nov2019 as previously reported.New information from product quality complaints reported on 05nov2019 includes: severity ranking.No follow-up attempts are possible.No further information is expected.Company clinical evaluation comment: the patient reported that "he noticed that a lot of the thermacare wraps were getting too hot".No adverse event was associated with the use of the device.This is a single potential device malfunction which has a theoretical risk to cause skin burn.No further investigations or actions is suggested at this time.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.No remedial action/corrective action/field safety corrective action is suggested at this time., comment: the patient reported that "he noticed that a lot of the thermacare wraps were getting too hot".No adverse event was associated with the use of the device.This is a single potential device malfunction which has a theoretical risk to cause skin burn.No further investigations or actions is suggested at this time.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.No remedial action/corrective action/field safety corrective action is suggested at this time.

Manufacturer Narrative

Event Description

Event verbatim [preferred term] noticed a lot of the thermacare wraps were getting too hot [device issue].Case narrative:this is a spontaneous report from a non-contactable consumer.A male patient of an unspecified age started to use thermacare heatwrap (thermacare lower back & hip), via an unspecified route of administration from an unspecified date, for an unspecified indication.Medical history and concomitant medications were not reported.The patient gets 30 wraps a month and "a bunch of them are no good" on unknown dates.The patient received a letter that they had been recalled, and the week before he received the letter regarding the recall, he noticed a lot of the thermacare wraps were getting too hot.The action taken with thermacare heatwrap in response to the event and the outcome of the event were both unknown.On 01oct2019, product quality complaint group provided following investigation findings: samples available: no.Sample status: not available.Severity of harm: n/a.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 adverse event safety request for investigation.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 adverse event safety request for investigation.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.Reserve sample evaluation and test required: no, unknown lot number.Lot-specific trend identified: no.A lot trend was not performed as the lot number is unknown.Follow up (01oct2019): new information received from a product quality complaint group includes: investigation summary and conclusion, and other investigation findings.This case was upgraded to a reportable mdr.Amendment: this follow-up report is being submitted to amend previously reported information: lot number (did not belong to this report) removed from narrative.Company clinical evaluation comment: the patient reported that "he noticed that a lot of the thermacare wraps were getting too hot".No adverse event was associated with the use of the device.This is a single potential device malfunction which has a theoretical risk to cause skin burn.No further investigations or actions is suggested at this time.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.No remedial action/corrective action/field safety corrective action is suggested at this time., comment: the patient reported that "he noticed that a lot of the thermacare wraps were getting too hot".No adverse event was associated with the use of the device.This is a single potential device malfunction which has a theoretical risk to cause skin burn.No further investigations or actions is suggested at this time.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.No remedial action/corrective action/field safety corrective action is suggested at this time.

Event Description

Noticed a lot of the thermacare wraps were getting too hot [device issue], narrative: this is a spontaneous report from a non-contactable consumer.A male patient of an unspecified age started to use thermacare heatwrap (thermacare lower back & hip), via an unspecified route of administration from an unspecified date, for an unspecified indication.Medical history and concomitant medications were not reported.The patient gets 30 wraps a month and "a bunch of them are no good" on unknown dates.The patient received a letter that they had been recalled, and the week before he received the letter regarding the recall, he noticed a lot of the thermacare wraps were getting too hot.The action taken with thermacare heatwrap in response to the event and the outcome of the event were both unknown.On 01oct2019, product quality complaint group provided following investigation findings: samples available: no.Sample status: not available.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 adverse event safety request for investigation.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 adverse event safety request for investigation.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.Reserve sample evaluation and test required: no, unknown lot number.Lot-specific trend identified: no.A lot trend was not performed as the lot number is unknown.Product quality complaints provided severity of harm ranking: s3.Follow up (01oct2019): new information received from a product quality complaint group includes: investigation summary and conclusion, and other investigation findings.This case was upgraded to a reportable mdr.Amendment: this follow-up report is being submitted to amend previously reported information: lot number (did not belong to this report) removed from narrative.Follow-up (31oct2019 and 05nov2019): this case is being submitted to notify that the prior amendment information for this case was first received by the company on 31oct2019 and not on 05nov2019 as previously reported.New information from product quality complaints reported on 05nov2019 includes: severity ranking.No follow-up attempts are possible.No further information is expected.No follow-up attempts are possible.No further information is expected., comment: the patient reported that "he noticed that a lot of the thermacare wraps were getting too hot".No adverse event was associated with the use of the device.This is a single potential device malfunction which has a theoretical risk to cause skin burn.No further investigations or actions is suggested at this time.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.No remedial action / corrective action/field safety corrective action is suggested at this time.

Manufacturer Narrative

Samples available: no.Sample status: not available.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 adverse event safety request for investigation.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 adverse event safety request for investigation.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.Reserve sample evaluation and test required: no, unknown lot number.Lot-specific trend identified: no.A lot trend was not performed as the lot number is unknown.Product quality complaints provided severity of harm ranking: s3.

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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

9263993

MDR Text Key

220335613

Report Number

1066015-2019-00469

Device Sequence Number

Product Code

IMD

Combination Product (y/n)

PMA/PMN Number

K953442

Number of Events Reported

Summary Report (Y/N)

Report Source

Manufacturer

Source Type

consumer

Type of Report

Initial,Followup,Followup,Followup

Report Date

05/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

Date FDA Received

10/31/2019

Is this an Adverse Event Report?

Is this a Product Problem Report?

Yes

Device Operator

Lay User/Patient

Was Device Available for Evaluation?

Is This a Reprocessed and Reused Single-Use Device?

Patient Sequence Number

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

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