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

Device Problem Break (1069)

Patient Problem Skin Irritation (2076)

Event Type  malfunction  

Event Description

Event verbatim [preferred term] irritating her skin [skin irritation], product was coming apart [device breakage].Case narrative:this is a spontaneous report from a contactable consumer.A female patient of an unspecified age started to receive thermacare heatwrap (thermacare lower back & hip), from an unspecified date at unknown frequency for an unspecified indication.The patient medical history and concomitant medications were not reported.The patient got a phone call regarding the thermacare product recall.She had a package of the thermacare lower back and hip heatwraps.She cannot provide a lot number, because she threw the product away.It was unable to confirm if the patient had an affected lot.The patient stated the product was coming apart and the heat cells were irritating her skin.Device was not available for evaluation.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.Company clinical evaluation comment: based on the available information, the patient reported that the product was coming apart and the heat cells were irritating her skin.This is a potential device malfunction.The event irritating her skin was caused by heat cell which could be due to cell leakage.The events are medically assessed as associated with the use of the device.The case will be reassessed if relevant additional medical information becomes available.Comment: based on the available information, the patient reported that the product was coming apart and the heat cells were irritating her skin.This is a potential device malfunction.The event irritating her skin was caused by heat cell which could be due to cell leakage.The events are medically assessed as associated with the use of the device.The case will be reassessed if relevant additional medical information becomes available.

Manufacturer Narrative

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.

Event Description

Event verbatim [preferred term] irritating her skin [skin irritation] , product was coming apart [device breakage].Case narrative:this is a spontaneous report from a contactable consumer.A female patient of an unspecified age started to receive thermacare heatwrap (thermacare lower back & hip), from an unspecified date at unknown frequency for an unspecified indication.The patient medical history and concomitant medications were not reported.The patient got a phone call regarding the thermacare product recall.She had a package of the thermacare lower back and hip heatwraps.She cannot provide a lot number, because she threw the product away.It was unable to confirm if the patient had an affected lot.The patient stated the product was coming apart and the heat cells were irritating her skin.Device was not available for evaluation.The action taken in response to the events for thermacare heatwrap was unknown.The outcome of the events was unknown.According to investigation report from product quality complaints summary, 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.Follow-up (28may2019): new information received from product quality complaints group included: investigation results.Company clinical evaluation comment: based on the available information, the patient reported that the product was coming apart and the heat cells were irritating her skin.This is a potential device malfunction.The event irritating her skin was caused by heat cell which could be due to cell leakage.The events are medically assessed as associated with the use of the device.The case will be reassessed if relevant additional medical information becomes available.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: based on the available information, the patient reported that the product was coming apart and the heat cells were irritating her skin.This is a potential device malfunction.The event irritating her skin was caused by heat cell which could be due to cell leakage.The events are medically assessed as associated with the use of the device.The case will be reassessed if relevant additional medical information becomes available.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.

Event Description

Irritating her skin [skin irritation], product was coming apart [device breakage].Case narrative: this is a spontaneous report from a contactable consumer.A female patient of an unspecified age started to use thermacare heatwrap (thermacare lower back & hip) from an unspecified date at unknown frequency for an unspecified indication.The patient's medical history and concomitant medications were not reported.The patient got a phone call regarding the thermacare product recall.She had a package of the thermacare lower back and hip heatwraps.She cannot provide a lot number, because she threw the product away, and unable to confirm if the patient had an affected lot.The patient stated the product was coming apart and the heat cells were irritating her skin.Device was not available for evaluation.Action taken in response to the events for thermacare heatwrap was unknown.The outcome of the events was unknown.According to investigation report from product quality complaints summary, 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.Severity of harm: s3.Based on the complaint narrative, the patient experienced leaking heat cells that irritated the patient's skin.Review of complaint description concludes there is a device malfunction.Follow-up (28may2019): new information received from product quality complaints group included: investigation results.Follow-up (01jul2019): follow-up attempts are completed.No further information is expected.Follow-up (28oct2019): new information received from product quality complaints group included: severity of harm and pqc conclusion.Company clinical evaluation comment: based on the available information, the patient reported that the product was coming apart and the heat cells were irritating her skin.The event irritating her skin was caused by heat cell which could be due to cell leakage.The events are medically assessed as associated with the use of the device.This is a single potential device malfunction which has a theoretical risk to cause skin burn.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: based on the available information, the patient reported that the product was coming apart and the heat cells were irritating her skin.The event irritating her skin was caused by heat cell which could be due to cell leakage.The events are medically assessed as associated with the use of the device.This is a single potential device malfunction which has a theoretical risk to cause skin burn.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

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.

Event Description

Event verbatim [preferred term] : irritating her skin [skin irritation], product was coming apart [device breakage], , narrative: this is a spontaneous report from a contactable consumer.A female patient of an unspecified age started to use thermacare heatwrap (thermacare lower back & hip) from an unspecified date at unknown frequency for an unspecified indication.The patient's medical history and concomitant medications were not reported.The patient got a phone call regarding the thermacare product recall.She had a package of the thermacare lower back and hip heatwraps.She cannot provide a lot number, because she threw the product away, and unable to confirm if the patient had an affected lot.The patient stated the product was coming apart and the heat cells were irritating her skin.Device was not available for evaluation.Action taken in response to the events for thermacare heatwrap was unknown.The outcome of the events was unknown.According to investigation report from product quality complaints summary: 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.Severity of harm was s3.According to product complaint group on (b)(6) 2019, the root cause category is non-assignable (complaint not confirmed as a quality defect).This investigation was conducted for an unknown lot number lower back/hip 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 product quality related trend identified for the subclass came apart/separated/torn (excludes damaged cells).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.Lot trend assessment and rationale: a lot trend was not performed as the lot number is unknown.Reasonably suggest device malfunction was yes.Severity of harm was s1.Site sample status was not received.Follow-up ((b)(6) 2019): new information received from product quality complaints group included: investigation results.Follow-up ((b)(6) 2019): follow-up attempts are completed.No further information is expected.Follow-up ((b)(6) 2019): new information received from product quality complaints group included: severity of harm and pqc conclusion.Follow-up ((b)(6) 2019): new information received from a product complaint group included: investigation result for subclass came apart/separated/torn (excludes damaged cells).Follow-up attempts are completed.No further information is expected.

Manufacturer Narrative

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.Severity of harm was s3.The root cause category is non-assignable (complaint not confirmed as a quality defect).This investigation was conducted for an unknown lot number lower back/hip 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 product quality related trend identified for the subclass came apart/separated/torn (excludes damaged cells).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.Lot trend assessment and rationale: a lot trend was not performed as the lot number is unknown.Reasonably suggest device malfunction was yes.Severity of harm was s1.Site sample status was not received.

• 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: 8605681
• MDR Text Key: 204067463
• Report Number: 1066015-2019-00145
• 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: 05/01/2019

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
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/13/2019
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 06/05/2019; 11/15/2019; 08/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1