MAUDE Adverse Event Report: PFIZER CONSUMER HEALTH CARE THERMACARE MENSTRUAL; DISPOSABLE PACK, HOT

Lot Number J23219

Device Problems Leak/Splash (1354); Structural Problem (2506)

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

Event Type  malfunction  

Manufacturer Narrative

Our 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.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.The consumer returned sample shows the wraps had cells that were cut by the final knife allowing chemistry to leak out side of the wrap.A previous investigation was completed for this batch with confirmed cells cut and chemistry leaking to outside of wrap.The investigation determined the most probable root cause of this defect is classified as method/document does not exist.There is no manufacturing working instruction (mwi) that explains how to perform die-cutter re-adjustments during production.In addition, no procedure was identified that contains the instruction to open the cull station during the die-cutter re-adjustments to ensure all produced wraps are rejected and do not move to the packaging portion of the manufacturing line.During production of batch j23219 two different shifts noted die cutter openings due to issues keeping die phasing in time with the wraps.The electrical and instrumentation (e&i) technicians had to re-phase the die in order to prevent cutting cells.When re-phasing the die, the technician should open the cull station manually to ensure no defective wraps are allowed to transition to packaging.This phasing outage can develop during normal production operations due to web movement while transitioning through the manufacturing line.Preventative action was issued to create a manufacturing work instruction for die cutter calibration.

Event Description

Event verbatim [preferred term] heat wrap is cut wrong, so the granulate leaks out [device leakage].Case narrative: this is a spontaneous report from a contactable pharmacist.A patient of unspecified age and gender started to use thermacare heatwrap (thermacare menstrual) (device lot number j23219, expiration date aug2017) from an unspecified date for an unspecified indication.The patient's medical history and concomitant medications were not reported.On an unspecified date, the patient reported the heatwrap is cut wrong, so the granulate leaks out.Action taken with the suspect product was unknown.Clinical outcome of the event was unknown.Additional information received from product quality complaint (pqc) group included investigation results.Our 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.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.The consumer returned sample shows the wraps had cells that were cut by the final knife allowing chemistry to leak out side of the wrap.A previous investigation was completed for this batch with confirmed cells cut and chemistry leaking to outside of wrap.The investigation determined the most probable root cause of this defect is classified as method/document does not exist.There is no manufacturing working instruction (mwi) that explains how to perform die-cutter re-adjustments during production.In addition, no procedure was identified that contains the instruction to open the cull station during the die-cutter re-adjustments to ensure all produced wraps are rejected and do not move to the packaging portion of the manufacturing line.During production of batch j23219 two different shifts noted die cutter openings due to issues keeping die phasing in time with the wraps.The electrical and instrumentation (e&i) technicians had to re-phase the die in order to prevent cutting cells.When re-phasing the die, the technician should open the cull station manually to ensure no defective wraps are allowed to transition to packaging.This phasing outage can develop during normal production operations due to web movement while transitioning through the manufacturing line.Preventative action was issued to create a manufacturing work instruction for die cutter calibration.Follow-up (23feb2017): new information received from product quality complaints (pqc) group included: product quality investigation results.No follow-up attempts are needed/possible.No further information is expected.Company clinical evaluation comment the event "heatwrap is cut wrong, so the granulate leaks out" (device leakage) was assessed as non-serious.No other adverse event was associated with the use of the device.This is a single potential device malfunction has a theoretical risk to cause skin burn.The event was assessed as associated with the use of the device., comment: the event "heatwrap is cut wrong, so the granulate leaks out" (device leakage) was assessed as non-serious.No other adverse event was associated with the use of the device.This is a single potential device malfunction has a theoretical risk to cause skin burn.The event was assessed as associated with the use of the device.

Event Description

Event verbatim [preferred term] heat wrap is cut wrong, so the granulate leaks out [device leakage].Case narrative:this is a spontaneous report from a contactable pharmacist.A patient of unspecified age and gender started to use thermacare heatwrap (thermacare menstrual) (device lot number j23219, expiration date aug2017) from an unspecified date for an unspecified indication.The patient's medical history and concomitant medications were not reported.On an unspecified date, the patient experienced the heatwrap was cut wrong, so the granulate leaks out.Action taken with the suspect product was unknown.Clinical outcome of the event was unknown.Additional information received from product quality complaint (pqc) group included investigation results.Our 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.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.The consumer returned sample shows the wraps had cells that were cut by the final knife allowing chemistry to leak out side of the wrap.A previous investigation was completed for this batch with confirmed cells cut and chemistry leaking to outside of wrap.The investigation determined the most probable root cause of this defect is classified as method/document does not exist.There is no manufacturing working instruction (mwi) that explains how to perform die-cutter re-adjustments during production.In addition, no procedure was identified that contains the instruction to open the cull station during the die-cutter re-adjustments to ensure all produced wraps are rejected and do not move to the packaging portion of the manufacturing line.During production of batch j23219 two different shifts noted die cutter openings due to issues keeping die phasing in time with the wraps.The electrical and instrumentation (e&i) technicians had to re-phase the die in order to prevent cutting cells.When re-phasing the die, the technician should open the cull station manually to ensure no defective wraps are allowed to transition to packaging.This phasing outage can develop during normal production operations due to web movement while transitioning through the manufacturing line.Preventative action was issued to create a manufacturing work instruction for die cutter calibration.Follow-up (23feb2017): new information received from product quality complaints (pqc) group included: product quality investigation results.No follow-up attempts are needed/possible.No further information is expected.Follow-up (16dec2019): this follow-up report is being submitted as a final reportable mdr., comment: the event "heatwrap is cut wrong, so the granulate leaks out" (device leakage) was assessed as non-serious.No other adverse event was associated with the use of the device.This is a single potential device malfunction has a theoretical risk to cause skin burn.The event was assessed as associated with the use of the device.Company conducted an investigation, and the most probable root cause for this event was classified, capa was implemented, and no further action is recommended.

Manufacturer Narrative

Our 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.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.The consumer returned sample shows the wraps had cells that were cut by the final knife allowing chemistry to leak out side of the wrap.A previous investigation was completed for this batch with confirmed cells cut and chemistry leaking to outside of wrap.The investigation determined the most probable root cause of this defect is classified as method/document does not exist.There is no manufacturing working instruction (mwi) that explains how to perform die-cutter re-adjustments during production.In addition, no procedure was identified that contains the instruction to open the cull station during the die-cutter re-adjustments to ensure all produced wraps are rejected and do not move to the packaging portion of the manufacturing line.During production of batch j23219 two different shifts noted die cutter openings due to issues keeping die phasing in time with the wraps.The electrical and instrumentation (e&i) technicians had to re-phase the die in order to prevent cutting cells.When re-phasing the die, the technician should open the cull station manually to ensure no defective wraps are allowed to transition to packaging.This phasing outage can develop during normal production operations due to web movement while transitioning through the manufacturing line.Preventative action was issued to create a manufacturing work instruction for die cutter calibration.

• Brand Name: THERMACARE MENSTRUAL
• Type of Device: DISPOSABLE PACK, HOT
• Manufacturer (Section D): PFIZER CONSUMER HEALTH CARE; 1231 wyandotte drive; albany GA 31705
• MDR Report Key: 9263328
• MDR Text Key: 219955650
• Report Number: 1066015-2019-00451
• 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
• Report Date: 01/10/2017

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: 08/01/2017
• Device Lot Number: J23219
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/31/2019
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1