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

Lot Number N15789

Device Problem Leak/Splash (1354)

Patient Problem Exposure to Body Fluids (1745)

Event Type  malfunction  

Event Description

This is a spontaneous report from a contactable consumer.A female patient of an unspecified age started to use thermacare heatwrap (thermacare neck, shoulder & wrist) device lot number n15789, expiration date feb2019, from an unspecified date at an unspecified frequency for neck stiffness, and neck pain.The patient medical history and concomitant medications were not reported.The consumer reported "i am reporting non-functioning of product.I opened wrap two of two in the box that failed to heat so far.I rely on this product immensely as i travel a lot and don't have access to microwave a rice sock that my friends keep reminding me work well, and have no expense compared to your product.The product failures of the heat wraps product that i have encountered over the years such as cell leakage and just failure to heat.When stuck in a hotel room with no car, at late hours, or even a foreign city, you can imagine my inability to fix the issue and the related frustration, not to mention the neck stiffness and pain that does not get treated and cycles to the next day and beyond.The action taken with thermacare and the outcome of the event were unknown.No follow-up attempts needed.No further information expected.Follow-up (15sep2016): this follow-up report is being submitted to upgrade this case to a reportable mdr.Company clinical evaluation comment the event 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 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

Summary: the root cause for never worked, too cool, did not last long enough and squeeze tube complaint sub classless is due to a pouch (primary packaging) that did not seal completely (open pouch).An open pouch will expose the wrap to air before the consumer gets it, causing it to be spent and not heating up.An open pouch is caused by equipment; specifically, ultrasonic technology.The corrective action is to purchase and install three (3) new heat seal flow wrapper machines in both production lines.The severity of pouch leaks is s1 no harm to customer.Reasonably suggest device malfunction was yes.Site sample status was not received.

Event Description

Event verbatim [preferred term] failed to heat so far/ cell leakage and just failure to heat [device leakage] ,.Case narrative:this is a spontaneous report from a contactable consumer.A female patient of an unspecified age started to use thermacare heatwrap (thermacare neck, shoulder & wrist) device lot number n15789, expiration date 28feb2019, from an unspecified date at an unspecified frequency for neck stiffness, and neck pain.The patient medical history and concomitant medications were not reported.The consumer reported "i am reporting non-functioning of product.I opened wrap two of two in the box that failed to heat so far.I rely on this product immensely as i travel a lot and don't have access to microwave a rice sock that my friends keep reminding me work well, and have no expense compared to your product.The product failures of the heat wraps product that i have encountered over the years such as cell leakage and just failure to heat.When stuck in a hotel room with no car, at late hours, or even a foreign city, you can imagine my inability to fix the issue and the related frustration, not to mention the neck stiffness and pain that does not get treated and cycles to the next day and beyond.The action taken with thermacare and the outcome of the event were unknown.The device was available for evaluation.Product investigation results were as follows: summary: the root cause for never worked, too cool, did not last long enough and squeeze tube complaint sub classless is due to a pouch (primary packaging) that did not seal completely (open pouch).An open pouch will expose the wrap to air before the consumer gets it, causing it to be spent and not heating up.An open pouch is caused by equipment; specifically, ultrasonic technology.The corrective action is to purchase and install three (3) new heat seal flow wrapper machines in both production lines.The severity of pouch leaks is s1 no harm to customer.Reasonably suggest device malfunction was yes.Site sample status was not received.No follow-up attempts needed.No further information expected.Follow-up (15sep2016): this follow-up report is being submitted to upgrade this case to a reportable mdr.Follow-up (23dec2019): follow-up attempts are completed.No further information is expected.Follow-up (07jan2020): new information received from a product quality complaint group includes product investigation summary and updated expiration date.Follow-up attempts are completed.No further information is expected.Company clinical evaluation comment the event 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, the root cause for this event was identified, corrective action was implemented, and no further action is recommended., comment: the event 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, the root cause for this event was identified, corrective action was implemented, and no further action is recommended.

• 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: 9257244
• MDR Text Key: 220049621
• Report Number: 1066015-2019-00314
• 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
• Report Date: 09/15/2016

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: 02/28/2019
• Device Lot Number: N15789
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/30/2019
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1