MAUDE Adverse Event Report: PFIZER CONSUMER HEALTH CARE THERMACARE JOINT & ARTHRITIS PAIN NECK, SHOULDER & WRIST; DISPOSABLE PACK, HOT

Lot Number M74984

Device Problem Leak/Splash (1354)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

The information in this report was regarded as either involving an event or a malfunction associated with an s3 or greater severity.Investigation summary: the root cause category is non-assignable (complaint not confirmed).The alleged defective sample has not been received at the site.Without the defective wrap for evaluation, the complaint cannot be confirmed.A photograph of the defective wrap was attached to the pcom (pfizer global complaint database) file by the affiliate at intake, the photograph does not provide enough information to determine a root cause for a defect.Our manufacturing operations employ quality control procedures which include statistical sampling, thermal testing and visual inspection, to ensure the quality of the product being packaged.No quality issues were identified upon this review of the batch device history record, in process attributes and variable quality checks or, inspection of retained samples.Retained samples met the product description and the product is within expiration date.If the defective samples are received at the site, the complaint file will be reopened and the file revised to include the return sample results.

Event Description

Event verbatim [preferred term] wraps seemed to be expose already/inside the wrap looked like they had oozed some green discharge [device leakage] ,.Case narrative:this is a spontaneous report from a non-contactable consumer.A patient of unspecified age and gender, started to use thermacare heatwrap (thermacare joint & arthritis pain neck, shoulder & wrist) (device lot: m74984, expiration date: oct2016) from an unknown date and for chronic pain.No relevant medical history or concomitant medication were reported.The person complained about the purchased product, as when the patient opened 2 boxes at the morning of the reporting, the wraps seemed to have been exposed to air already.It was reported that they did not heat and the pockets were very hard rather than soft as usual.Also when the patient looked at the inside the wrap looked like they had oozed some green discharge.The action taken with the thermacare and the outcome of the event were unknown.The product quality complaint group provided summary dated 07jul2016, as follows: the information in this report was regarded as either involving an event or a malfunction associated with an s3 or greater severity.Investigation summary: the root cause category is non-assignable (complaint not confirmed).The alleged defective sample has not been received at the site.Without the defective wrap for evaluation, the complaint cannot be confirmed.A photograph of the defective wrap was attached to the pcom (pfizer global complaint database) file by the affiliate at intake, the photograph does not provide enough information to determine a root cause for a defect.Our manufacturing operations employ quality control procedures which include statistical sampling, thermal testing and visual inspection, to ensure the quality of the product being packaged.No quality issues were identified upon this review of the batch device history record, in process attributes and variable quality checks or, inspection of retained samples.Retained samples met the product description and the product is within expiration date.If the defective samples are received at the site, the complaint file will be reopened and the file revised to include the return sample results.No follow-up attempts are possible.No further information is expected.Company clinical evaluation comment based on the available information, the report of suspected device leakage (wraps seemed to be expose already/inside the wrap looked like they had oozed some green discharge) has been identified prior to use of the device and the consumer did not use the device.No adverse event was associated with the use of the device.This single event malfunction has a theoretical risk to cause skin burn.This case will be re-assessed should additional information becomes available., comment: based on the available information, the report of suspected device leakage (wraps seemed to be expose already/inside the wrap looked like they had oozed some green discharge) has been identified prior to use of the device and the consumer did not use the device.No adverse event was associated with the use of the device.This single event malfunction has a theoretical risk to cause skin burn.This case will be re-assessed should additional information becomes available.

Manufacturer Narrative

The information in this report was regarded as either involving an event or a malfunction associated with an s3 or greater severity.Investigation summary: the root cause category is non-assignable (complaint not confirmed).The alleged defective sample has not been received at the site.Without the defective wrap for evaluation, the complaint cannot be confirmed.A photograph of the defective wrap was attached to the pcom (pfizer global complaint database) file by the affiliate at intake, the photograph does not provide enough information to determine a root cause for a defect.Our manufacturing operations employ quality control procedures which include statistical sampling, thermal testing and visual inspection, to ensure the quality of the product being packaged.No quality issues were identified upon this review of the batch device history record, in process attributes and variable quality checks or, inspection of retained samples.Retained samples met the product description and the product is within expiration date.If the defective samples are received at the site, the complaint file will be reopened and the file revised to include the return sample results.

Event Description

Event verbatim [preferred term] wraps seemed to be expose already/inside the wrap looked like they had oozed some green discharge [device leakage] ,.Case narrative:this is a spontaneous report from a non-contactable consumer.A patient of unspecified age and gender, started to use thermacare heatwrap (thermacare joint & arthritis pain neck, shoulder & wrist) (device lot: m74984, expiration date: oct2016) from an unknown date and for chronic pain.No relevant medical history or concomitant medication were reported.The person complained about the purchased product, as when the patient opened 2 boxes at the morning of the reporting, the wraps seemed to have been exposed to air already.It was reported that they did not heat and the pockets were very hard rather than soft as usual.Also when the patient looked at the inside the wrap looked like they had oozed some green discharge.The action taken with the thermacare and the outcome of the event were unknown.The product quality complaint group provided summary dated 07jul2016, as follows: the information in this report was regarded as either involving an event or a malfunction associated with an s3 or greater severity.Investigation summary: the root cause category is non-assignable (complaint not confirmed).The alleged defective sample has not been received at the site.Without the defective wrap for evaluation, the complaint cannot be confirmed.A photograph of the defective wrap was attached to the pcom (pfizer global complaint database) file by the affiliate at intake, the photograph does not provide enough information to determine a root cause for a defect.Our manufacturing operations employ quality control procedures which include statistical sampling, thermal testing and visual inspection, to ensure the quality of the product being packaged.No quality issues were identified upon this review of the batch device history record, in process attributes and variable quality checks or, inspection of retained samples.Retained samples met the product description and the product is within expiration date.If the defective samples are received at the site, the complaint file will be reopened and the file revised to include the return sample results.No follow-up attempts are possible.No further information is expected.Follow-up (24dec2019): this follow-up is being submitted to notify that an investigation of the device is ongoing.Company clinical evaluation comment based on the available information, the report of suspected device leakage (wraps seemed to be expose already/inside the wrap looked like they had oozed some green discharge) has been identified prior to use of the device and the consumer did not use the device.No adverse event was associated with the use of the device.This single event malfunction has a theoretical risk to cause skin burn.This case will be re-assessed should additional information becomes available., comment: based on the available information, the report of suspected device leakage (wraps seemed to be expose already/inside the wrap looked like they had oozed some green discharge) has been identified prior to use of the device and the consumer did not use the device.No adverse event was associated with the use of the device.This single event malfunction has a theoretical risk to cause skin burn.This case will be re-assessed should additional information becomes available.

Event Description

Event verbatim [preferred term] wraps seemed to be expose already/inside the wrap looked like they had oozed some green discharge [device leakage] ,.Case narrative:this is a spontaneous report from a non-contactable consumer.A patient of unspecified age and gender, started to use thermacare heatwrap (thermacare joint & arthritis pain neck, shoulder & wrist) (device lot: m74984, expiration date: oct2016) from an unknown date and for chronic pain.No relevant medical history or concomitant medication were reported.The person complained about the purchased product, as when the patient opened 2 boxes at the morning of the reporting (b)(6) 2016, the wraps seemed to have been exposed to air already.It was reported that they did not heat and the pockets were very hard rather than soft as usual.Also when the patient looked at the inside the wrap looked like they had oozed some green discharge.The action taken with the thermacare and the outcome of the event were unknown.The product quality complaint group provided summary dated 07jul2016, as follows: the information in this report was regarded as either involving an event or a malfunction associated with an s3 or greater severity.Investigation summary: the root cause category is non-assignable (complaint not confirmed).The alleged defective sample has not been received at the site.Without the defective wrap for evaluation, the complaint cannot be confirmed.A photograph of the defective wrap was attached to the pcom (pfizer global complaint database) file by the affiliate at intake, the photograph does not provide enough information to determine a root cause for a defect.Our manufacturing operations employ quality control procedures which include statistical sampling, thermal testing and visual inspection, to ensure the quality of the product being packaged.No quality issues were identified upon this review of the batch device history record, in process attributes and variable quality checks or, inspection of retained samples.Retained samples met the product description and the product is within expiration date.If the defective samples are received at the site, the complaint file will be reopened and the file revised to include the return sample results.No follow-up attempts are possible.No further information is expected.Follow-up (24dec2019): this follow-up is being submitted to notify that an investigation of the device is ongoing.Follow-up (19feb2020): this follow-up report is being submitted to upgrade this case to a final reportable mdr., comment: based on the available information, the report of suspected device leakage (wraps seemed to be expose already/inside the wrap looked like they had oozed some green discharge) has been identified prior to use of the device and the consumer did not use the device.No adverse event was associated with the use of the device.This single event malfunction has a theoretical risk to cause skin burn.The event was assessed associated with the use of the device.This case will be re-assessed should additional information becomes available.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.

Manufacturer Narrative

The information in this report was regarded as either involving an event or a malfunction associated with an s3 or greater severity.Investigation summary: the root cause category is non-assignable (complaint not confirmed).The alleged defective sample has not been received at the site.Without the defective wrap for evaluation, the complaint cannot be confirmed.A photograph of the defective wrap was attached to the pcom (pfizer global complaint database) file by the affiliate at intake, the photograph does not provide enough information to determine a root cause for a defect.Our manufacturing operations employ quality control procedures which include statistical sampling, thermal testing and visual inspection, to ensure the quality of the product being packaged.No quality issues were identified upon this review of the batch device history record, in process attributes and variable quality checks or, inspection of retained samples.Retained samples met the product description and the product is within expiration date.If the defective samples are received at the site, the complaint file will be reopened and the file revised to include the return sample results.

• Brand Name: THERMACARE JOINT & ARTHRITIS PAIN NECK, SHOULDER & WRIST
• Type of Device: DISPOSABLE PACK, HOT
• Manufacturer (Section D): PFIZER CONSUMER HEALTH CARE; 1231 wyandotte drive; albany GA 31705
• MDR Report Key: 9263344
• MDR Text Key: 219211417
• Report Number: 1066015-2019-00452
• 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,foreign
• Type of Report: Initial,Followup,Followup
• Report Date: 05/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/01/2016
• Device Lot Number: M74984
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/31/2019
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 12/31/2019; 03/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1