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

Lot Number T65624

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

Patient Problems Erythema (1840); Irritation (1941); Rash (2033); Swelling (2091); Partial thickness (Second Degree) Burn (2694)

Event Date 04/17/2019

Event Type  Injury  

Event Description

5 or 6 red circles from the heat of the patch on his lower back irritating his skin, more like a rash, has gotten bigger and has blistered up [burns second degree], it was just from the heat of the patch on his lower back [device issue].Case narrative: this is a spontaneous report from a contactable consumer reporting for himself.A (b)(6) male patient started to receive thermacare heatwrap (thermacare lower back & hip), device lot number t65624, expiration date nov2020, via an unspecified route of administration from an unspecified date for an unspecified indication.Medical history was reported as none.The patient's concomitant medications were not reported.The patient previously used thermacare heatwrap and he had no problems initially like.The reporter stated he used one of the thermacare back and hip wrap patches (it was the first time).He put it directly on his skin later that night ((b)(6) 2019) he had like 5 or 6 red circles from where he put directly on his skin, "i should not have done that".He just thought that it was just from the heat of the patch on his lower back, the next day ((b)(6) 2019, also reported as last thursday) the circles got a little bit bigger and it was irritating his skin more like a rash and each day since then irritation has gotten bigger and it has blistered up, start date of blisters would have been the (b)(6) 2019.He received hydrocortisone cream as treatment.He went to see a doctor on (b)(6) 2019 about the rash.He just happened to look online to see if that was typical that happened and to see if it was recalled some of the patches, the lot number was not one of the lot numbers that was recalled but he did not know if that was or still could be a potential issue with those, so he was calling to see if it is still possible that you did not recall it.He has already thrown the package away, but other than those who came with it.He had the lot number as t65624.The action taken for the product was unknown.The outcome of the event "5 or 6 red circles from where he put directly on his skin/ it has blistered up" and "it was just from the heat of the patch on his lower back" was not resolved and for other events was unknown.Additional information has been requested and will be provided as it becomes available.Company clinical evaluation comment: based on the information provided, the event of "5 or 6 red circles from the heat of the patch on his lower back irritating his skin, more like a rash, has gotten bigger and has blistered up" as described are considered serious bodily injury 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

Rsnbly suggest device malfunc?: no.Sample status: not requested.Complaint sub-class: adverse event safety request for investigation.Conclusion: the root cause category is non-assignable (complaint not confirmed as a quality defect).After a review of the batch thermal records, thermal results all met product release criteria.Consumer reports "i put it (thermacare back and hip wrap) directly on my skin later that night i had like 5 or 6 red circles and i just thought that it was just from the heat of the patch on my lower back, the next day the circles got a little bit bigger and it was irritating my skin more like a rash and that was last thursday and each day since then irritation has gotten bigger and it has blistered up".The cause of the blister is inconclusive since review of records does not provide evidence to support defective product.The product effect may vary with each individual.The plant has reviewed this batch from a manufacturing perspective.No quality issues were identified upon this review of batch records, release testing data or, inspection of retained samples.Retained samples met the product description and the product is within expiration date.The product quality for the batch is not impacted by this complaint.

Event Description

Event verbatim [preferred term] 5 or 6 red circles from the heat of the patch on his lower back irritating his skin, more like a rash, has gotten bigger and has blistered up [burns second degree] , it was just from the heat of the patch on his lower back [device issue] ,.Case narrative:this is a spontaneous report from a contactable consumer reporting for himself.A 44-year-old male patient started to receive thermacare heatwrap (thermacare lower back & hip), device lot number t65624, expiration date 30nov2020, via an unspecified route of administration from an unspecified date for an unspecified indication.Medical history was reported as none.The patient's concomitant medications were not reported.The patient previously used thermacare heatwrap and he had no problems initially.The reporter stated he used one of the thermacare back and hip wrap patches (it was the first time).He put it directly on his skin later that night ((b)(6) 2019) he had like 5 or 6 red circles from where he put directly on his skin, "i should not have done that".He just thought that it was just from the heat of the patch on his lower back, the next day ((b)(6) 2019, also reported as last thursday) the circles got a little bit bigger and it was irritating his skin more like a rash and each day since then irritation has gotten bigger and it has blistered up, start date of blisters would have been the (b)(6) 2019.He received hydrocortisone cream as treatment.He went to see a doctor on (b)(6) 2019 about the rash.He just happened to look online to see if that was typical that happened and to see if it was recalled some of the patches, the lot number was not one of the lot numbers that was recalled but he did not know if that was or still could be a potential issue with those, so he was calling to see if it is still possible that you did not recall it.He has already thrown the package away, but other than those who came with it.He had the lot number as t65624.The action taken for the product was unknown.The outcome of the event " 5 or 6 red circles from the heat of the patch on his lower back irritating his skin, more like a rash, has gotten bigger and has blistered up" and "it was just from the heat of the patch on his lower back" was not resolved.According to product quality complaint group: rsnbly suggest device malfunc?: no.Sample status: not requested.Complaint sub-class: adverse event safety request for investigation.Conclusion: the root cause category is non-assignable (complaint not confirmed as a quality defect).After a review of the batch thermal records, thermal results all met product release criteria.Consumer reports "i put it (thermacare back and hip wrap) directly on my skin later that night i had like 5 or 6 red circles and i just thought that it was just from the heat of the patch on my lower back, the next day the circles got a little bit bigger and it was irritating my skin more like a rash and that was last thursday and each day since then irritation has gotten bigger and it has blistered up".The cause of the blister is inconclusive since review of records does not provide evidence to support defective product.The product effect may vary with each individual.The plant has reviewed this batch from a manufacturing perspective.No quality issues were identified upon this review of batch records, release testing data or, inspection of retained samples.Retained samples met the product description and the product is within expiration date.The product quality for the batch is not impacted by this complaint.Follow-up (28jun2019): follow-up attempts completed.No further information is expected.Amendment: this follow-up report is being submitted to amend previously reported information: event onset date updated from (b)(6) 2018 to (b)(6) 2019; subsequently, patient age updated from 43-years-old to 44-years-old.Follow-up (03aug2019): new information received from product quality complaint group includes investigation results.Company clinical evaluation comment based on the information provided, the event of "5 or 6 red circles from the heat of the patch on his lower back irritating his skin, more like a rash, has gotten bigger and has blistered up" as described are considered serious bodily injury 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.The review of the lot/batch records does not suggest a defect or quality issue related to the manufacture of this lot.No device malfunction has been identified.No remedial action/corrective action/field safety corrective action is suggested at this time., comment: based on the information provided, the event of "5 or 6 red circles from the heat of the patch on his lower back irritating his skin, more like a rash, has gotten bigger and has blistered up" as described are considered serious bodily injury 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.The review of the lot/batch records does not suggest a defect or quality issue related to the manufacture of this lot.No device malfunction has been identified.No remedial action/corrective action/field safety corrective action is suggested at this time.

Event Description

Event verbatim [preferred term] 5 or 6 red circles from the heat of the patch on his lower back irritating his skin, more like a rash, has gotten bigger and has blistered up [burns second degree] , it was just from the heat of the patch on his lower back [device issue] ,.Case narrative:this is a spontaneous report from a contactable consumer reporting for himself.A 44-year-old male patient started to receive thermacare heatwrap (thermacare lower back & hip), device lot number t65624, expiration date nov2020, via an unspecified route of administration from an unspecified date for an unspecified indication.Medical history was reported as none.The patient's concomitant medications were not reported.The patient previously used thermacare heatwrap and he had no problems initially.The reporter stated he used one of the thermacare back and hip wrap patches (it was the first time).He put it directly on his skin later that night (17apr2019) he had like 5 or 6 red circles from where he put directly on his skin, "i should not have done that".He just thought that it was just from the heat of the patch on his lower back, the next day (18apr2019, also reported as last thursday) the circles got a little bit bigger and it was irritating his skin more like a rash and each day since then irritation has gotten bigger and it has blistered up, start date of blisters would have been the 18apr2019.He received hydrocortisone cream as treatment.He went to see a doctor on 22apr2019 about the rash.He just happened to look online to see if that was typical that happened and to see if it was recalled some of the patches, the lot number was not one of the lot numbers that was recalled but he did not know if that was or still could be a potential issue with those, so he was calling to see if it is still possible that you did not recall it.He has already thrown the package away, but other than those who came with it.He had the lot number as t65624.The action taken for the product was unknown.The outcome of the event "5 or 6 red circles from where he put directly on his skin/ it has blistered up" and "it was just from the heat of the patch on his lower back" was not resolved and for other events was unknown.Additional information has been requested and will be provided as it becomes available.Follow-up (28jun2019): follow-up attempts completed.No further information is expected.Amendment: this follow-up report is being submitted to amend previously reported information: event onset date updated from 17apr2018 to 17apr2019; subsequently, patient age updated from 43-years-old to 44-years-old.Company clinical evaluation comment based on the information provided, the event of "5 or 6 red circles from the heat of the patch on his lower back irritating his skin, more like a rash, has gotten bigger and has blistered up" as described are considered serious bodily injury 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 event of "5 or 6 red circles from the heat of the patch on his lower back irritating his skin, more like a rash, has gotten bigger and has blistered up" as described are considered serious bodily injury 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.

• 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: 8568675
• MDR Text Key: 143706487
• Report Number: 1066015-2019-00125
• 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: 04/22/2019

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
• Device Expiration Date: 11/30/2020
• Device Lot Number: T65624
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/01/2019
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 08/12/2019; 08/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 44 YR
• Patient Weight: 97