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

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

Patient Problems Pain (1994); Patient Problem/Medical Problem (2688)

Event Type  Injury  

Event Description

Other thermacare heatwraps hurt to have stuck to body [pain].Case narrative: this is a spontaneous report from a contactable consumer (patient).A (b)(6) female patient started to receive thermacare heatwrap (thermacare heatwrap) from unknown date and ongoing at unknown frequency for unknown indication.Medical history was none.Concomitant medications were none.Consumer had used other thermacare heatwraps and it hurt to have them stuck to her body, she was unsure of the name of the other thermacare heatwraps that hurt to have them stuck to her body, stated she used them for a while and then tried the thermacare menstrual pain therapy heatwraps and noticed those were perfect and stated those did not hurt her.Consumer stated the ones that hurt her to stick on her body were the same size but had the sticky on them and she did not have those anymore, stated she used them a long time ago, and did not have the lot number, expiry date, or upc numbers to provide.Consumer could not recall exact start and stop dates of thermacare heatwraps that hurt to stick to her body but stated it was when she first started using them at about age (b)(6).Consumer further reported that she was admitted to hospital for the event thermacare heatwraps hurt to have stuck to body and did not receive treatment.Consumer would like to see more of products that stick to clothing instead of skin.The action taken in response to the event of the product was unknown.The outcome of the event was resolved.Additional information has been requested and will be provided as it becomes available.Follow-up (13mar2019): new information received from a contactable consumer includes device information, deny of treatment, hospitalization information and case upgraded to be serious, reportable mdr.Company clinical evaluation comment: based on the information provided, the event 'pain' with hospitalization as described in this case is considered as serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure, assessed as associated with the use of the device.

Manufacturer Narrative

Summary of investigation: this investigation was conducted for an unknown lot number joint therapy 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 adverse event safety request for investigation.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.

Event Description

Event verbatim [preferred term] other thermacare heatwraps hurt to have stuck to body [pain] ,.Case narrative:this is a spontaneous report from a contactable consumer (patient).A 55-years-old female patient started to receive thermacare heatwrap (thermacare heatwrap) from unknown date and ongoing at unknown frequency for unknown indication.Medical history was none.Concomitant medications were none.Consumer had used other thermacare heatwraps and it hurt to have them stuck to her body, she was unsure of the name of the other thermacare heatwraps that hurt to have them stuck to her body, stated she used them for a while and then tried the thermacare menstrual pain therapy heatwraps and noticed those were perfect and stated those did not hurt her.Consumer stated the ones that hurt her to stick on her body were the same size but had the sticky on them and she did not have those anymore, stated she used them a long time ago, and did not have the lot number, expiry date, or upc numbers to provide.Consumer could not recall exact start and stop dates of thermacare heatwraps that hurt to stick to her body but stated it was when she first started using them at about age 55.Consumer further reported that she was admitted to hospital for the event thermacare heatwraps hurt to have stuck to body and did not receive treatment.Consumer would like to see more of products that stick to clothing instead of skin.The action taken in response to the event of the product was unknown.The outcome of the event was resolved.According to product quality complaint group: summary of investigation: this investigation was conducted for an unknown lot number joint therapy 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 adverse event safety request for investigation.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.Follow-up (13mar2019): new information received from a contactable consumer includes device information, deny of treatment, hospitalization information and case upgraded to be serious, reportable mdr.Follow-up (01aug2019): new information received from a product quality complaint group included: investigation results.Company clinical evaluation comment based on the information provided, the event 'pain' with hospitalization as described in this case is considered as serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure, 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: based on the information provided, the event 'pain' with hospitalization as described in this case is considered as serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure, 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

This investigation was conducted for an unknown lot number joint therapy 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 adverse event safety request for investigation.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.Severity of harm: s3 - serious, injury, which could result in the need for medical treatment and hospitalization.

Event Description

Event verbatim [preferred term] other thermacare heatwraps hurt to have stuck to body [pain] ,.Case narrative:this is a spontaneous report from a contactable consumer (patient).A 55-years-old female patient started to use thermacare heatwrap (thermacare heatwrap) from unknown date and ongoing at unknown frequency for unknown indication.Medical history was none.Concomitant medications were none.The patient had used other thermacare heatwraps and it hurt to have them stuck to her body, she was unsure of the name of the other thermacare heatwraps that hurt to have them stuck to her body, stated she used them for a while and then tried the thermacare menstrual pain therapy heatwraps and noticed those were perfect and stated those did not hurt her.The patient stated the ones that hurt her to stick on her body were the same size but had the sticky on them and she did not have those anymore, stated she used them a long time ago, and did not have the lot number, expiry date, or upc numbers to provide.She could not recall exact start and stop dates of thermacare heatwraps that hurt to stick to her body but stated it was when she first started using them at about age 55.The patient further reported that she was admitted to hospital for the event the heatwraps hurt to have stuck to body and did not receive treatment.Consumer would like to see more of products that stick to clothing instead of skin.The action taken in response to the event of the product was unknown.The outcome of the event was resolved.According to product quality complaint group: summary of investigation: this investigation was conducted for an unknown lot number joint therapy 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 adverse event safety request for investigation.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.Severity of harm: s3 - serious, injury, which could result in the need for medical treatment and hospitalization.Follow-up (13mar2019): new information received from a contactable consumer includes device information, deny of treatment, hospitalization information and case upgraded to be serious, reportable mdr.Follow-up (01aug2019): new information received from a product quality complaint group included: investigation results.Follow up (06aug2019): new information received from product quality complaints (pqc) group included: severity ranking was provided as s3.Company clinical evaluation comment based on the information provided, the event 'pain' with hospitalization as described in this case is considered as serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure, 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: based on the information provided, the event 'pain' with hospitalization as described in this case is considered as serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure, 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.

• 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: 8457054
• MDR Text Key: 140149029
• Report Number: 1066015-2019-00077
• 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
• Report Date: 01/30/2019

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?: No
• Device Operator: Lay User/Patient
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/27/2019
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 08/12/2019; 08/27/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 55 YR
• Patient Weight: 54