MAUDE Adverse Event Report: PFIZER CONSUMER HEALTH CARE THERMACARE LOWER BACK & HIP; DISPOSABLE PACK, HOT

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

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

Event Type  malfunction  

Event Description

Event verbatim [preferred term] two heat wraps of a 6ct pack had damaged heat cells where the content leaked.[device leakage].Case narrative: this is a spontaneous report from a contactable pharmacist.A patient of unspecified age and gender started to receive thermacare heatwrap (thermacare lower back & hip), device lot number and expiration date were not provided, via an unspecified route of administration 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 'two heat wraps of a 6 ct.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.Additional information has been requested and will be provided as it becomes available.Company clinical evaluation comment: the event "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 "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.

Event Description

Event verbatim [preferred term] two heat wraps of a 6ct pack had damaged heat cells where the content leaked.[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 lower back & hip) (device lot number and expiration date were not provided) from an unspecified date to an unspecified date for an unspecified indication.The patient's medical history and concomitant medications were not reported.The patient experienced "two heat wraps of a 6 ct.Pack had damaged heat cells where the content leaked" on an unspecified date.Action taken with thermacare heatwrap and the outcome of the event was not reported.Severity ranking: s3.Additional information has been requested and will be provided as it becomes available.Follow-up (11nov2019): new information received from product quality complaints (pqc) group included: severity ranking: s3.Company clinical evaluation comment the event "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 "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 non-assignable (complaint not confirmed as a quality defect).There was limited device specific information provided, no batch number or return sample was available for evaluation.Without a batch reference number and/or return sample a manufacturing and technical evaluation cannot be completed for the wrap involved in this case.There is not a product quality related trend identified for the subclass cells damaged/leaking.The 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.

Event Description

Event verbatim [preferred term] two heat wraps of a 6ct pack had damaged heat cells where the content leaked.[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 lower back & hip) (device lot number and expiration date were not provided) from an unspecified date to an unspecified date for an unspecified indication.The patient's medical history and concomitant medications were not reported.The patient experienced "two heat wraps of a 6 ct.Pack had damaged heat cells where the content leaked" on an unspecified date.Action taken with thermacare heatwrap and the outcome of the event was unknown.Severity ranking: s3.According to the product quality complaint group: there is reasonable suspicion of a device malfunction.The impact is cell leakage and the severity is s3-skin burn- per rpt- (b)(4)hazard analysis thermacare heat wrap product: 8 and 12 hour.Investigational results: the root cause category is non-assignable (complaint not confirmed as a quality defect).There was limited device specific information provided, no batch number or return sample was available for evaluation.Without a batch reference number and/or return sample a manufacturing and technical evaluation cannot be completed for the wrap involved in this case.There is not a product quality related trend identified for the subclass cells damaged/leaking.The 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.Follow-up (11nov2019): new information received from product quality complaints (pqc) group included: severity ranking: s3.Follow-up (21nov2019): new information received from the product quality complaint group includes malfunction assessment and investigational results.No follow-up attempts are needed.No further information expected., comment: the event "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 which has a theoretical risk to cause skin burn.The event was assessed as associated with the use of the device.There was limited device specific information provided, no batch number or return sample was available for evaluation.Without a batch reference number and/or return sample a manufacturing and technical evaluation cannot be completed for the wrap involved in this case.Product effect varies with each individual.No further investigations or actions is suggested at this time.

• Brand Name: THERMACARE LOWER BACK & HIP
• Type of Device: DISPOSABLE PACK, HOT
• Manufacturer (Section D): PFIZER CONSUMER HEALTH CARE; 1231 wyandotte drive; albany GA 31705
• MDR Report Key: 9263325
• MDR Text Key: 219957106
• Report Number: 1066015-2019-00463
• 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: 07/27/2016

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
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1