MAUDE Adverse Event Report: PFIZER CONSUMER HEALTH CARE THERMACARE FUER FLEXIBLE ANWENDUNG; DISPOSABLE PACK, HOT

Lot Number T48921

Device Problem Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

It is confirmed that there was leakage from the cells [device leakage] ,.Case narrative:the initial case was missing the following minimum criteria: no adverse event.Upon receipt of follow-up information on (b)(6) 2019, this case now contains all required information to be considered valid.This is a spontaneous report from a contactable pharmacist.A patient of unspecified age and gender started to use thermacare heatwrap (thermacare fuer flexible anwendung), device lot number t48921, expiration date nov2020, from an unspecified date for an unspecified indication.The patient's medical history and concomitant medications were not reported.The patient experienced it is confirmed that there was leakage from the cells on an unspecified date.The action taken with thermacare heatwrap was unknown.The outcome of the event was unknown.Additional information has been requested and will be provided as it becomes available.Company clinical evaluation comment.The patient reported "it is confirmed that there was leakage from the cells".No adverse event was associated with the use of the device.This is a single potential device malfunction which has a theoretical risk to cause skin burn.The company is conducting further review and additional follow-up will be reported when it becomes available., comment: the patient reported "it is confirmed that there was leakage from the cells".No adverse event was associated with the use of the device.This is a single potential device malfunction which has a theoretical risk to cause skin burn.The company is conducting further review and additional follow-up will be reported when it becomes available.

Event Description

Event verbatim [preferred term] it is confirmed that there was leakage from the cells [device leakage].Case narrative:the initial case was missing the following minimum criteria: no adverse event.Upon receipt of follow-up information on 19jul2019, this case now contains all required information to be considered valid.This is a spontaneous report from a contactable pharmacist.A patient of unspecified age and gender started to use thermacare heatwrap (thermacare fuer flexible anwendung), device lot number t48921, expiration date nov2020, from an unspecified date for an unspecified indication.The patient's medical history and concomitant medications were not reported.The patient experienced it is confirmed that there was leakage from the cells on an unspecified date.The action taken with thermacare heatwrap was unknown.The outcome of the event was unknown.The severity rank was s3 (the impact is cell leakage and the severity is s3-skin burn- per rpt- 38832 hazard analysis thermacare heat wrap product: 8 and 12 hour).Additional information has been requested and will be provided as it becomes available.Follow-up (12aug2019): new information received via dsu us includes severity assessment.Company clinical evaluation comment the patient reported "it is confirmed that there was leakage from the cells." no adverse event was associated with the use of the device.This is a single potential device malfunction which has a theoretical risk to cause skin burn.The company is conducting further review and additional follow-up will be reported when it becomes available., comment: the patient reported "it is confirmed that there was leakage from the cells".No adverse event was associated with the use of the device.This is a single potential device malfunction which has a theoretical risk to cause skin burn.The company is conducting further reviewand additional follow-up will be reported when it becomes available.

Event Description

Event verbatim [preferred term] it is confirmed that there was leakage from the cells [device leakage] ,.Case narrative:the initial case was missing the following minimum criteria: no adverse event.Upon receipt of follow-up information on (b)(6) 2019, this case now contains all required information to be considered valid.This is a spontaneous report from a contactable pharmacist.A patient of unspecified age and gender started to use thermacare heatwrap (thermacare fuer flexible anwendung), device lot number t48921, expiration date (b)(6) 2020, from an unspecified date for an unspecified indication.The patient's medical history and concomitant medications were not reported.The patient experienced it is confirmed that there was leakage from the cells on an unspecified date.The action taken with thermacare heatwrap was unknown.The outcome of the event was unknown.According to product quality complaint group: the severity rank was s3 (the impact is cell leakage and the severity is s3-skin burn- per rpt- 38832 hazard analysis thermacare heat wrap product: 8 and 12 hour).Conclusion: the most probable root cause category for this event is "method / document doesn't exist".The fulm cut wraps could be produced because the operator after the die registration recalibration put back the line cull from manual to auto mode and he did not wait enough time to let the blow off system to eject all wraps produced during the recalibration process.This allowed to the potential cut wraps located on the overhead conveyor passed downstream to the pack system.There is not a document or method that establishes how to calibrate the die for the flex use large muscle (fulm) product.Therefore, the most probable cause of this incident is method.Commitment (b)(4) was issued to create a document that establishes how to calibrate the die registration for the flex use large muscle (fulm) product.The document should establish how to manage the product produced during the die registration re-calibration.No market action is recommended because batch t48921 met all product release criteria and it will remain in release status.There are specific product use instructions on the carton, pouch film and insert stating, "do not use if the heat cell contents leak and/or wrap is damaged or torn".Batch t48921 remains in release status.Batch t48921 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.The visual inspection of a retain sample included four cartons, eight pouches and the eight wraps inside and shows no obvious defects.There are no cells damaged or leaking.Form-46455 retain sample inspection form documented the retain evaluation performed on (b)(6) 2018.An evaluation of the complaint history confirms that this is the first complaint for the sub class cells damaged/leaking for this batch.On the basis of this evaluation, a trend does not exist for this batch.An evaluation was made by searching for possible trends for this subclass requiring investigation by the site.The following pcom (pfizer global complaint database) search was performed.Scope: date contacted: (b)(6) 2016 through (b)(6) 2018/manufacturing site: pfizer albany/complaint class: wrap/patch/pad/ complaint sub class: cells damaged/leaking.The pcom search returned a total of four complaints for flex use large muscle (flex use xl) products during this time period for the class/subclass.Of the four complaints; two complaints have batch number recorded as "unknown".The two remaining complaints were evaluated.One of the previous complaints ((b)(4)) was confirmed to have a manufacturing process root cause for cells damaged/leaking complaint; equipment-mechanical failure.Based on this pcom search, there is not a trend identified for the subclass of cells damaged/leaking for flex use xl 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 was one wrap attribute defect recorded for the batch; dead cell (an individual cell not dosed with brine solution will not heat up).The brine pump was replaced and calibrated to correct the dead cell defect.There was one wrap variable defect recorded for the batch.Neither of the defects mentioned above would cause a cells damaged or leaking defect.Shiftly transition production notes were reviewed.There was one occurrence of vision machine direction faults, the die was opened until the wed tracked back into proper position and then production was resumed.This batch has been reviewed from a manufacturing perspective.There are no known site investigations associated with this batch involving cells damaged/leaking defects.The visual inspection of a retain sample included four cartons, eight pouches and the eight wraps inside and shows no obvious defects.There are no cells damaged or leaking.Form-46455 retain sample inspection form documented the retain evaluation performed on (b)(6) 2018.Follow-up ((b)(6) 2019): new information received via dsu us includes severity assessment.Follow-up ((b)(6) 2019): new information received from product quality complaint group included: investigation results., comment: the patient reported "it is confirmed that there was leakage from the cells".No adverse event was associated with the use of the device.This is a single potential device malfunction which has a theoretical risk to cause skin burn.The company is conducting further reviewand additional follow-up will be reported when it becomes available.

Manufacturer Narrative

The severity rank was s3 (the impact is cell leakage and the severity is s3-skin burn- per rpt- 38832 hazard analysis thermacare heat wrap product: 8 and 12 hour).Conclusion: the most probable root cause category for this event is "method / document doesn't exist".The fulm cut wraps could be produced because the operator after the die registration recalibration put back the line cull from manual to auto mode and he did not wait enough time to let the blow off system to eject all wraps produced during the recalibration process.This allowed to the potential cut wraps located on the overhead conveyor passed downstream to the pack system.There is not a document or method that establishes how to calibrate the die for the flex use large muscle (fulm) product.Therefore, the most probable cause of this incident is method.Commitment (b)(4) was issued to create a document that establishes how to calibrate the die registration for the flex use large muscle (fulm) product.The document should establish how to manage the product produced during the die registration re-calibration.No market action is recommended because batch t48921 met all product release criteria and it will remain in release status.There are specific product use instructions on the carton, pouch film and insert stating, "do not use if the heat cell contents leak and/or wrap is damaged or torn".Batch t48921 remains in release status.Batch t48921 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.The visual inspection of a retain sample included four cartons, eight pouches and the eight wraps inside and shows no obvious defects.There are no cells damaged or leaking.Form-46455 retain sample inspection form documented the retain evaluation performed on (b)(6) 2018.An evaluation of the complaint history confirms that this is the first complaint for the sub class cells damaged/leaking for this batch.On the basis of this evaluation, a trend.

• Brand Name: THERMACARE FUER FLEXIBLE ANWENDUNG
• Type of Device: DISPOSABLE PACK, HOT
• Manufacturer (Section D): PFIZER CONSUMER HEALTH CARE; 1231 wyandotte drive; albany GA 31705
• MDR Report Key: 8874450
• MDR Text Key: 216597804
• Report Number: 1066015-2019-00211
• 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: foreign,health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 05/25/2018

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: 11/01/2020
• Device Lot Number: T48921
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/08/2019
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 08/28/2019; 08/30/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1