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

Lot Number T11466C

Device Problems Break (1069); Leak/Splash (1354)

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

Event Type  malfunction  

Manufacturer Narrative

The root cause category is equipment.Evaluation of the return sample shows the wrap is leaking stray chemistry between the cell pack and sca laminate.A previous investigation for the same defect, same batch; determined the most probable root cause is equipment category, mechanical failure.The returned wrap, found that the defect was caused due to pre-mix powder (chemistry) between two layers of the heatwrap (sca/ cell pack).This powder prevented the glue from bonding the two layers of the heatwrap.Shiftly transitions notes stated that the drive side (d/s) edge of the powder dosing belt was found cracked making contact with the vibratory tray preventing the tray from conveying the excess pre-mix powder from the recycling belt through the vibratory tray.Instead, this was causing the powder accumulation on the drive side of the platens where it was transported downstream to the discharge of the hpm cart and it fell onto the sca web.This contamination to the sca is just prior to the sca material and the cell pack being combined together where it encapsulated the powder preventing the glue from adhering the two materials.There is one confirmed complaint for this batch for the subclass of cells damaged/leaking.A full investigation was completed for the defect.There are no additional actions to be completed at this time.

Event Description

Event verbatim [preferred term] the heat wrap of a 1ct pack had damaged heat cells where the content leaked [device leakage] ,.Case narrative:this is a spontaneous report from a non-contactable consumer.A patient of unspecified age and gender started to receive thermacare heatwrap (thermacare neck, shoulder & wrist) , device lot number t11466c, expiration date apr2020 , from an unspecified date to an unspecified date for an unspecified indication.The patient medical history and concomitant medications were not reported.The patient experienced the heat wrap of a 1ct pack had damaged heat cells where the content leaked on an unspecified date.The action taken with thermacare heatwrap and the outcome of the event was not reported.According to the product quality group a summary of pfizer albany investigation: the root cause category is equipment.Evaluation of the return sample shows the wrap is leaking stray chemistry between the cell pack and sca laminate.A previous investigation for the same defect, same batch; determined the most probable root cause is equipment category, mechanical failure.The returned wrap found that the defect was caused due to pre-mix powder (chemistry) between two layers of the heatwrap (sca/ cell pack).This powder prevented the glue from bonding the two layers of the heatwrap.Shiftly transitions notes stated that the drive side (d/s) edge of the powder dosing belt was found cracked making contact with the vibratory tray preventing the tray from conveying the excess pre-mix powder from the recycling belt through the vibratory tray.Instead, this was causing the powder accumulation on the drive side of the platens where it was transported downstream to the discharge of the hpm cart and it fell onto the sca web.This contamination to the sca is just prior to the sca material and the cell pack being combined together where it encapsulated the powder preventing the glue from adhering the two materials.There is one confirmed complaint for this batch for the subclass of cells damaged/leaking.A full investigation was completed for the defect.There are no additional actions to be completed at this time.Company clinical evaluation comment the event "ct pack had damaged heat cells where the content leaked " (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 "ct pack had damaged heat cells where the content leaked " (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.

Manufacturer Narrative

The root cause category is equipment.Evaluation of the return sample shows the wrap is leaking stray chemistry between the cell pack and sca laminate.A previous investigation for the same defect, same batch; determined the most probable root cause is equipment category, mechanical failure.The returned wrap, found that the defect was caused due to pre-mix powder (chemistry) between two layers of the heatwrap (sca/ cell pack).This powder prevented the glue from bonding the two layers of the heatwrap.Shiftly transitions notes stated that the drive side (d/s) edge of the powder dosing belt was found cracked making contact with the vibratory tray preventing the tray from conveying the excess pre-mix powder from the recycling belt through the vibratory tray.Instead, this was causing the powder accumulation on the drive side of the platens where it was transported downstream to the discharge of the hpm cart and it fell onto the sca web.This contamination to the sca is just prior to the sca material and the cell pack being combined together where it encapsulated the powder preventing the glue from adhering the two materials.There is one confirmed complaint for this batch for the subclass of cells damaged/leaking.A full investigation was completed for the defect.There are no additional actions to be completed at this time.

Event Description

Event verbatim [preferred term] the heat wrap of a 1ct pack had damaged heat cells where the content leaked [device leakage].Case narrative:this is a spontaneous report from a non-contactable consumer.A patient of unspecified age and gender started to receive thermacare heatwrap (thermacare neck, shoulder & wrist) , device lot number t11466c, expiration date apr2020 , from an unspecified date to an unspecified date for an unspecified indication.The patient medical history and concomitant medications were not reported.The patient experienced the heat wrap of a 1ct pack had damaged heat cells where the content leaked on an unspecified date.The action taken with thermacare heatwrap and the outcome of the event was not reported.According to the product quality group a summary of pfizer albany investigation: the root cause category is equipment.Evaluation of the return sample shows the wrap is leaking stray chemistry between the cell pack and sca laminate.A previous investigation for the same defect, same batch; determined the most probable root cause is equipment category, mechanical failure.The returned wrap found that the defect was caused due to pre-mix powder (chemistry) between two layers of the heatwrap (sca/ cell pack).This powder prevented the glue from bonding the two layers of the heatwrap.Shiftly transitions notes stated that the drive side (d/s) edge of the powder dosing belt was found cracked making contact with the vibratory tray preventing the tray from conveying the excess pre-mix powder from the recycling belt through the vibratory tray.Instead, this was causing the powder accumulation on the drive side of the platens where it was transported downstream to the discharge of the hpm cart and it fell onto the sca web.This contamination to the sca is just prior to the sca material and the cell pack being combined together where it encapsulated the powder preventing the glue from adhering the two materials.There is one confirmed complaint for this batch for the subclass of cells damaged/leaking.A full investigation was completed for the defect.There are no additional actions to be completed at this time.Follow-up (16dec2019): this follow-up report is being submitted as a final reportable mdr., comment: the event "1ct pack had damaged heat cells where the content leaked " (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.The root cause category is equipment.There is one confirmed complaint for this batch for the subclass of cells damaged/leaking.A full investigation was completed for the defect.There are no additional actions to be completed at this time.

• Brand Name: THERMACARE 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: 9263355
• MDR Text Key: 220258655
• Report Number: 1066015-2019-00436
• 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
• Report Date: 05/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/31/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/01/2020
• Device Lot Number: T11466C
• Was Device Available for Evaluation?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1