MAUDE Adverse Event Report: PFIZER CONSUMER HEALTH CARE THERMACARE MUSCLE & JOINT; DISPOSABLE PACK, HOT

Lot Number S68516

Device Problem Temperature Problem (3022)

Patient Problems Pain (1994); Rash (2033); Partial thickness (Second Degree) Burn (2694)

Event Date 10/22/2018

Event Type  Injury  

Event Description

Event verbatim [preferred term] got a red lining where patch was placed that started to burn and then the next day it was blistered [burns second degree], skin rash [rash], it turned into a nasty scab [application site scab].Case narrative: this is a spontaneous report based on the information received by pfizer via us fda (mw5081842) from a contactable consumer.A patient of unspecified age and gender started to receive thermacare heatwrap (thermacare heatwraps multi-purpose muscle pain), device lot number s68516 , expiration date 01jul2020 , from 2018 at unknown frequency for pain.The patient medical history was not reported.The patient's concomitant medications were not reported.The patient got a red lining where patch was placed that started to burn and then the next day it was blistered and then after that it turned into a nasty scab on (b)(6) 2018.Skin rash that burned on (b)(6) 2018.Fda assessed events report type as serious injury, events as disability/permanent damage.Other serious (important medical event).The device was available for evaluation.The action taken in response to the events was unknown.The outcome of the event was unknown.Additional information has been requested and will be provided as it becomes available.

Manufacturer Narrative

The root cause category is non assignable (complaint not confirmed).There is not a product quality complaint associated with this complaint, consumer stated that "they did not leak".Our manufacturing operations employ quality control procedures which include in process testing, and visual inspection, to ensure the quality of the product being packaged.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.Investigation (b)(4) t26691, t26693, t26686 & s68516 menstrual & muscle joint us cells damaged/leaking was conducted for the sub-class of cells damaged/leaking.This batch: s68516 was reviewed at aqrt and the outcome determination was to recall the four batches (t26691, t26693, and t26686 & s68516) per investigation (b)(4).This current complaint does not involve cell pack damage/leaking.

Event Description

Got a red lining where patch was placed that started to burn and then the next day it was blistered [burns second degree], skin rash [rash] , it turned into a nasty scab [application site scab].Case narrative: this is a spontaneous report based on the information received by pfizer via us fda (mw5081842) from a contactable consumer.A patient of unspecified age and gender started to receive thermacare heatwrap (thermacare heatwraps multi-purpose muscle pain), device lot number: s68516 , expiration date 01jul2020 , from 2018 at unknown frequency for pain.The patient medical history was not reported.The patient's concomitant medications were not reported.The patient got a red lining where patch was placed that started to burn and then the next day it was blistered and then after that it turned into a nasty scab on (b)(6) 2018.Skin rash that burned on (b)(6) 2018.Fda assessed events report type as serious injury, events as disability/permanent damage.Other serious (important medical event).The device was available for evaluation.The action taken in response to the events was unknown.The outcome of the event was unknown.According to product quality complaint group: the root cause category is non assignable (complaint not confirmed).There is not a product quality complaint associated with this complaint, consumer stated that "they did not leak".Our manufacturing operations employ quality control procedures which include in process testing, and visual inspection, to ensure the quality of the product being packaged.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.Investigation (b)(4) t26691, t26693, t26686 & s68516 menstrual & muscle joint us cells damaged/leaking was conducted for the sub-class of cells damaged/leaking.This batch: s68516 was reviewed at aqrt and the outcome determination was to recall the four batches (t26691, t26693, and t26686 & s68516) per investigation (b)(4).This current complaint does not involve cell pack damage/leaking.Follow-up (11jan2019): new information received from a product quality complaint group included: investigation results.

Manufacturer Narrative

The root cause category is non assignable (complaint not confirmed).There is not a product quality complaint associated with this complaint, consumer stated that "they did not leak".Our manufacturing operations employ quality control procedures which include in process testing, and visual inspection, to ensure the quality of the product being packaged.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.Investigation (b)(4) t26691, t26693, t26686 & s68516 menstrual & muscle joint us cells damaged/leaking was conducted for the sub-class of cells damaged/leaking.This batch s68516 was reviewed at aqrt and the outcome determination was to recall the four batches (t26691, t26693, and t26686 & s68516) per investigation (b)(4).This current complaint does not involve cell pack damage/leaking.

Event Description

Got a red lining where patch was placed that started to burn and then the next day it was blistered [burns second degree], skin rash [rash], it turned into a nasty scab [application site scab].Case narrative: this is a spontaneous report based on the information received by pfizer via us fda (mw5081842) from a contactable consumer.A patient of unspecified age and gender started to receive thermacare heatwrap (thermacare muscle & joint), device lot number s68516 , expiration date 01jul2020 , from 2018 at unknown frequency for pain.The patient medical history was not reported.The patient's concomitant medications were not reported.The patient got a red lining where patch was placed that started to burn and then the next day it was blistered and then after that it turned into a nasty scab on (b)(6) 2018.Skin rash that burned on (b)(6) 2018.Fda assessed events report type as serious injury, events as disability/permanent damage.Other serious (important medical event).The device was available for evaluation.The action taken in response to the events was unknown.The outcome of the event was unknown.According to product quality complaint group: the root cause category is non assignable (complaint not confirmed).There is not a product quality complaint associated with this complaint, consumer stated that "they did not leak".Our manufacturing operations employ quality control procedures which include in process testing, and visual inspection, to ensure the quality of the product being packaged.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.Investigation (b)(4) t26691, t26693, t26686 & s68516.Menstrual & muscle joint us cells damaged/leaking was conducted for the sub-class of cells damaged/leaking.This batch s68516 was reviewed at aqrt and the outcome determination was to recall the four batches (t26691, t26693, and t26686 & s68516) per investigation (b)(4).This current complaint does not involve cell pack damage/leaking.Follow-up (11jan2019): new information received from a product quality complaint group included: investigation results.Amendment: this follow-up is being submitted to amend previously reported information: suspect product brand name (updated to thermacare muscle & joint).No follow-up attempts are possible.No further information is expected.

Manufacturer Narrative

Batch s68516 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.The visual inspection of retain samples included one carton, and the four pouched wraps inside each (4 wraps total).Inspection shows no obvious defects to the cartons or pouches.All wraps have cell packs with good seals, with no damage or leaking.Retain inspection was completed on 27mar2018 for a previous unrelated complaint.An evaluation of the complaint history confirms that this is the sixth complaint for the sub class adverse event safety request for investigation received at the albany site requiring an evaluation for this batch.One of the previous complaints (#; pr #) was confirmed to have a manufacturing related root cause for the complaint equipment, other.On the basis of this evaluation, a trend does not exist for this batch.Based on this pcom search for the subclass of adverse event safety request for investigation for muscle and joint products the data did not show an increase over time (36 months).There is not a trend identified for the subclass adverse event safety request for investigation for muscle and joint products.Review of the batch device history record for this batch concludes all release requirements were met.The review of the manufacturing attributes and variables quality checks associated with this batch indicates that all required in process inspections were performed and all inspection criteria were met.There were no wrap attribute or variable defects recorded for the batch.Thermal data for the batch shows all wraps met the required wrap batch average temperatures per muscle and joint formula card #, effective date: 28nov2016.This batch has been reviewed from a manufacturing perspective.There are no known site investigations associated with this batch at the time of release.Investigation summary: the root cause category is non assignable (complaint not.

Event Description

Event verbatim [preferred term]: got a red lining where patch was placed that started to burn and then the next day it was blistered [burns second degree] , skin rash [rash] , it turned into a nasty scab [application site scab].Case narrative:this is a spontaneous report based on the information received by pfizer via us fda (mw5081842) from a contactable consumer.A patient of unspecified age and gender started to receive thermacare heatwrap (thermacare muscle & joint), device lot number s68516 , expiration date 01jul2020 , from 2018 at unknown frequency for pain.The patient medical history was not reported.The patient's concomitant medications were not reported.The patient got a red lining where patch was placed that started to burn and then the next day it was blistered and then after that it turned into a nasty scab on (b)(6)2018.Skin rash that burned on (b)(6)2018.Fda assessed events report type as serious injury, events as disability/permanent damage.Other serious (important medical event).The device was available for evaluation.The action taken in response to the events was unknown.The outcome of the event was unknown.According to product quality complaint group: initial complaint assessment: batch s68516 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.The visual inspection of retain samples included one carton, and the four pouched wraps inside each (4 wraps total).Inspection shows no obvious defects to the cartons or pouches.All wraps have cell packs with good seals, with no damage or leaking.Retain inspection was completed on 27mar2018 for a previous unrelated complaint.An evaluation of the complaint history confirms that this is the sixth complaint for the sub class adverse event safety request for investigation received at the albany site requiring an evaluation for this batch.One of the previous complaints (#; pr #) was confirmed to have a manufacturing related root cause for the complaint equipment, other.On the basis of this evaluation, a trend does not exist for this batch.Based on this pcom search for the subclass of adverse event safety request for investigation for muscle and joint products the data did not show an increase over time (36 months).There is not a trend identified for the subclass adverse event safety request for investigation for muscle and joint products.Review of the batch device history record for this batch concludes all release requirements were met.The review of the manufacturing attributes and variables quality checks associated with this batch indicates that all required in process inspections were performed and all inspection criteria were met.There were no wrap attribute or variable defects recorded for the batch.Thermal data for the batch shows all wraps met the required wrap batch average temperatures per muscle and joint formula card #, effective date: 28nov2016.This batch has been reviewed from a manufacturing perspective.There are no known site investigations associated with this batch at the time of release.Investigation summary: the root cause category is non assignable (complaint not confirmed).There is not a product quality complaint associated with this complaint, consumer stated that "they did not leak".Our manufacturing operations employ quality control procedures which include in process testing, and visual inspection, to ensure the quality of the product being packaged.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.Investigation (b)(4) t26691, t26693, t26686 & s68516 menstrual & muscle joint us cells damaged/leaking was conducted for the sub-class of cells damaged/leaking.This batch s68516 was reviewed at aqrt and the outcome determination was to recall the four batches (t26691, t26693, and t26686 & s68516) per investigation (b)(4).This current complaint does not involve cell pack damage/leaking.Site sample status was not received.Final confirmation status was not confirmed.Follow-up (11jan2019): new information received from a product quality complaint group included: investigation results.Amendment: this follow-up is being submitted to amend previously reported information: suspect product brand name (updated to thermacare muscle & joint).No follow-up attempts are possible.No further information is expected.Amendment: this follow-up report is being submitted to amend previously reported information: indication "pain" was added for thermacare heatwrap and initial complaint assessment was added.

• Brand Name: THERMACARE MUSCLE & JOINT
• Type of Device: DISPOSABLE PACK, HOT
• Manufacturer (Section D): PFIZER CONSUMER HEALTH CARE; 1231 wyandotte drive; albany GA 31705
• MDR Report Key: 8195767
• MDR Text Key: 131476844
• Report Number: 1066015-2018-00205
• 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: 12/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/26/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/01/2020
• Device Lot Number: S68516
• Was Device Available for Evaluation?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention; Disability