MAUDE Adverse Event Report: PFIZER CONSUMER HEALTH CARE ROBAX LOWER BACK & HIP HEATWRAP; 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

I was unable to test this product as a few of the pads had ruptured and there contents had leaked [device leakage].Case narrative: this is a spontaneous report from a pfizer-sponsored program robax website product reviews.A contactable consumer reported a patient of unspecified age and gender started to use thermacare heatwrap (robax lower back & hip heatwrap) 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 "i was unable to test this product as a few of the pads had ruptured and there contents had leaked".Action taken with the suspect product was unknown.Clinical outcome of the event was unknown.Additional information has been requested and will be provided as it becomes available.Company clinical evaluation comment: the event "a few of the pads had ruptured and there contents had 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 "a few of the pads had ruptured and there contents had 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] i was unable to test this product as a few of the pads had ruptured and there contents had leaked [device leakage].Case narrative:this is a spontaneous report from a pfizer-sponsored program robax website product reviews.A contactable consumer reported a patient of unspecified age and gender started to use thermacare heatwrap (robax lower back & hip heatwrap) 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 "i was unable to test this product as a few of the pads had ruptured and there contents had leaked".Action taken with the suspect product was unknown.Clinical outcome of the event was unknown.On (b)(6) 2019, it was reported that there was reasonable suspicion of a device malfunction.The impact is cell leakage and the severity is s3- skin burn - per hazard analysis thermacare heat wrap product: 8 and 12 hour.The site investigation is in process.Complaint subclass: heat cells damaged/leaking.Additional information has been requested and will be provided as it becomes available.Follow-up (11nov2019): new information received from product quality complaint group at glaxosmithkline included: severity rank, complaint subclass, and suspicion of a device malfunction.Company clinical evaluation comment: the event "a few of the pads had ruptured and there contents had 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 "a few of the pads had ruptured and there contents had 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] i was unable to test this product as a few of the pads had ruptured and there contents had leaked [device leakage].Case narrative:this is a spontaneous report from a pfizer-sponsored program robax website product reviews.A contactable consumer reported a patient of unspecified age and gender started to use thermacare heatwrap (robax lower back & hip heatwrap) 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 "i was unable to test this product as a few of the pads had ruptured and their contents had leaked".Action taken with the suspect product was unknown.Clinical outcome of the event was unknown.On 11nov2019, it was reported that there was reasonable suspicion of a device malfunction.The impact is cell leakage and the severity is s3- skin burn - per hazard analysis thermacare heat wrap product: 8 and 12 hour.Complaint subclass: heat cells damaged/leaking.According to the product quality complaint group: conclusion: 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 complaint group at glaxosmithkline included: severity rank, complaint subclass, and suspicion of a device malfunction.Follow-up (14nov2019): new information received from the product quality complaint group includes investigational results.No follow-up attempts possible.No further information expected., comment: based on the available information, the device leakage (contents had leaked) 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.A causal relationship between the device and the event cannot be ruled out.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.

Manufacturer Narrative

Conclusion: 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.

• Brand Name: ROBAX LOWER BACK & HIP HEATWRAP
• Type of Device: DISPOSABLE PACK, HOT
• Manufacturer (Section D): PFIZER CONSUMER HEALTH CARE; 1231 wyandotte drive; albany GA 31705
• MDR Report Key: 9263335
• MDR Text Key: 220010864
• Report Number: 1066015-2019-00443
• 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,Followup
• Report Date: 09/14/2016

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