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

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Purulent Discharge (1812); Itching Sensation (1943); Pain (1994); Rash (2033)

Event Type  Injury  

Manufacturer Narrative

This investigation was conducted for an unknown lot number of lbh.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/serious/unknown.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/serious/unknown.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.Exped trend actions taken: based on this citi customizable search for the subclass of adverse event/serious/unknown for lbh products the data did not show an increase over time (36 months).There is not a trend identified for the subclass of adverse event/serious/unknown for lbh product.Severity of harm: s3.

Event Description

Clusters of blisters along the affected area [blister], painful, itchy rash/inflamed rash [rash] , painful, itchy rash/inflamed rash [rash pruritic], blemishes [skin discolouration], inflamed rash [dermatitis] , uncomfortable [discomfort].Case narrative: this is a spontaneous report from a contactable consumer.A patient of unspecified age and gender started to use thermacare heatwrap (thermacare lower back & hip) (device lot number not reported) from an unspecified date for an unspecified indication.The patient's medical history and concomitant medications were not reported.The patient experienced clusters of blisters along the affected area on an unspecified date, painful, itchy rash on an unspecified date, blemishes on an unspecified date, inflamed rash on an unspecified date, and uncomfortable on an unspecified date.The patient stated 'it began about a week ago when i first noticed weird blemishes along the treated area.Assuming this was a normality, i ignored it.Until 2 days later when i started to notice the skin rising and beginning to form clusters of blisters along the affected area.I have since thrown away the product but i can guarantee you this is the last time i will purchase one of your products again.I have literally never had a rash in the 29 years that i've walked this earth until now.And this painful, itchy rash is ruining my ability to celebrate my father's 50th birthday.' action taken with thermacare heatwrap was unknown.The outcome of the events was unknown.Additional information received from product quality complaint (pqc) group included investigation results.This investigation was conducted for an unknown lot number of lbh.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/serious/unknown.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/serious/unknown.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.Exped trend actions taken: based on this citi customizable search for the subclass of adverse event/serious/unknown for lbh products the data did not show an increase over time (36 months).There is not a trend identified for the subclass of adverse event/serious/unknown for lbh product.Severity of harm: s3.Additional information has been requested and will be provided as it becomes available.Follow-up (02aug2019 and 22aug2019): new information received from the product quality complaint group included investigational results.Follow-up (05nov2019): this follow-up report is being submitted to upgrade this case to a reportable mdr.Company clinical evaluation comment: based on the information provided, the events blister, rash, rash pruritic, skin discolouration, dermatitis and discomfort as described are considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.The events are medically assessed as associated with the use of the device., comment: based on the information provided, the events blister, rash, rash pruritic, skin discolouration, dermatitis and discomfort as described are considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.The events are medically assessed as associated with the use of the device.

Manufacturer Narrative

This investigation was conducted for an unknown lot number of lbh.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/serious/unknown.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.Exped trend actions taken: based on this citi customizable search for the subclass of adverse event/serious/unknown for lbh products the data did not show an increase over time (36 months).There is not a trend identified for the subclass of adverse event/serious/unknown for lbh product, refer to attachment lbh adverse event serious unknown aug2016 to aug2019.Severity of harm: s3.Evaluation of complaints related to non-defect subclass introduction 1.Introduction thermacare heat wraps are premium topical heat therapy products.The heat wraps are worn against the body or over a layer of clothing to relieve minor muscular and joint aches and pains.The albany site is the sole manufacturing location for thermacare heat wraps.They are produced on two manufacturing lines; the b line produces the larger products which wrap around the body with stretch materials, and the m line produces the smaller products that are attached for use with pressure sensitive adhesives.The purpose of this document is to summarize customer complaints where there is no quality defect.Non-defect complaint represents a suggestion/concern about the existing product that does not include a product quality issue, but is related to a suggestion for improvement.2.Complai.

Event Description

Event verbatim [preferred term] clusters of blisters along the affected area [blister] , painful, itchy rash/inflamed rash [rash] , painful, itchy rash/inflamed rash [rash pruritic] , blemishes [skin discolouration] , inflamed rash [dermatitis] , uncomfortable [discomfort] ,.Case narrative:this is a spontaneous report from a contactable consumer.A patient of unspecified age and gender started to use thermacare heatwrap (thermacare lower back & hip) (device lot number not reported) from an unspecified date for an unspecified indication.The patient's medical history and concomitant medications were not reported.The patient experienced clusters of blisters along the affected area on an unspecified date, painful, itchy rash on an unspecified date, blemishes on an unspecified date, inflamed rash on an unspecified date, and uncomfortable on an unspecified date.The patient stated 'it began about a week ago when i first noticed weird blemishes along the treated area.Assuming this was a normality, i ignored it.Until 2 days later when i started to notice the skin rising and beginning to form clusters of blisters along the affected area.I have since thrown away the product but i can guarantee you this is the last time i will purchase one of your products again.I have literally never had a rash in the 29 years that i've walked this earth until now.And this painful, itchy rash is ruining my ability to celebrate my father's 50th birthday.' action taken with thermacare heatwrap was unknown.The outcome of the events was unknown.Additional information received from product quality complaint (pqc) group included investigation results.This investigation was conducted for an unknown lot number of lbh.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/serious/unknown.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.Exped trend actions taken: based on this citi customizable search for the subclass of adverse event/serious/unknown for lbh products the data did not show an increase over time (36 months).There is not a trend identified for the subclass of adverse event/serious/unknown for lbh product, refer to attachment lbh adverse event serious unknown aug2016 to aug2019.Severity of harm: s3.According to the product quality complaint group: evaluation of complaints related to non-defect subclass introduction 1.Introduction thermacare heat wraps are premium topical heat therapy products.The heat wraps are worn against the body or over a layer of clothing to relieve minor muscular and joint aches and pains.The albany site is the sole manufacturing location for thermacare heat wraps.They are produced on two manufacturing lines; the b line produces the larger products which wrap around the body with stretch materials, and the m line produces the smaller products that are attached for use with pressure sensitive adhesives.The purpose of this document is to summarize customer complaints where there is no quality defect.Non-defect complaint represents a suggestion/concern about the existing product that does not include a product quality issue but is related to a suggestion for improvement.2.Complaint handling for non-defect subclass complaints received at the site in the global complaint database related to non-defect will not be investigated in the global complaint database.These complaints will be evaluated in the global complaint database to ensure they are due to a non-defect issue.No additional investigation will be required for these complaints based on the following: released batches met specification criteria at the time of release.There is no severity assigned to a non-defect.This document will be attached to the complaint record in the global database and closed with no further action taken.Follow-up (02aug2019 and 22aug2019): new information received from the product quality complaint group included investigational results.Follow-up (05nov2019): this follow-up report is being submitted to upgrade this case to a reportable mdr.Follow-up (08aug2019): new information received from the product quality complaint group includes investigational results.Follow-up attempts completed.No further information expected.Company clinical evaluation comment: based on the information provided, the events blister, rash, rash pruritic, skin discolouration, dermatitis and discomfort as described are considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.A causal relationship between the device and the events cannot be ruled out.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.Follow-up (08nov2019): follow-up attempts are completed.No further information is expected., comment: based on the information provided, the events blister, rash, rash pruritic, skin discolouration, dermatitis and discomfort as described are considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.A causal relationship between the device and the events cannot be ruled out.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 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: 9301402
• MDR Text Key: 187162567
• Report Number: 1066015-2019-00474
• 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
• Report Date: 07/14/2019

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
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/08/2019
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention