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

Device Problems Leak/Splash (1354); Material Split, Cut or Torn (4008)

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

Event Type  malfunction  

Event Description

Event verbatim [preferred term] has split at the bottom felt like gravel in my trousers [device leakage] , has split at the bottom felt like gravel in my trousers [accidental exposure to product] ,.Case narrative:this is a spontaneous report from a contactable consumer.A female patient of an unspecified age started to receive thermacare heatwrap (thermacare lower back & hip), from an unspecified date at unknown frequency for an unspecified indication.The patient medical history and concomitant medications were not reported.The patient said that the back wrap had a split at the bottom while being worn.She said she used this product quite frequently and found it very effective but she was disappointed to discover what felt like gravel inside her trousers.The action taken in response to the events for thermacare heatwrap was unknown.The outcome of the events was unknown.Additional information has been requested and will be provided as it becomes available.Company clinical evaluation comment: based on the available information, the patient identified that the heatwrap has split at the bottom felt like gravel in my trousers.There was "no adverse reaction" such as burn associated with the use of the device.This malfunction has a theoretical risk to cause skin burn.The company is conducting a further review on this investigation, and additional follow-up will be reported when the evaluation is completed., comment: based on the available information, the patient identified that the heatwrap has split at the bottom felt like gravel in my trousers.There was "no adverse reaction" such as burn associated with the use of the device.This malfunction has a theoretical risk to cause skin burn.The company is conducting a further review on this investigation, and additional follow-up will be reported when the evaluation is completed.

Manufacturer Narrative

Initial complaint assessment: the pcom search returned a total of 64 complaints for lower back and hip products during this time period for the class/subclass.There were 7 complaints confirmed to have a manufacturing process root cause for a complaint of cells damaged/leaking.The complaints were evaluated to identify any potential trend.The calculated complaints per million produced (cpmp) result of 674 complaints was above the upper control limit (ucl) of 14 complaints per sop-105746 "complaint trending guideline", effective 05 feb 2019.An evaluation of the 36 month trend chart did not show a significant increase over time.Based on this pcom search, there is not a trend identified for the subclass of cells damaged/leaking for lower back and hip products.This complaint could not be associated with the confirmed ones as there is limited information.There is no further action required.Investigation summary: 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.Severity ranking was s3.

Event Description

Event verbatim [preferred term] has split at the bottom felt like gravel in my trousers [device leakage].Case narrative:this is a spontaneous report from a contactable consumer.A female patient of an unspecified age started to receive thermacare heatwrap (thermacare lower back & hip), from an unspecified date at unknown frequency for an unspecified indication.The patient medical history and concomitant medications were not reported.The patient said that the back wrap had a split at the bottom while being worn.She said she used this product quite frequently and found it very effective but she was disappointed to discover what felt like gravel inside her trousers.The action taken in response to the events for thermacare heatwrap was unknown.The outcome of the events was unknown.According to the product quality complaint group: initial complaint assessment: the pcom search returned a total of 64 complaints for lower back and hip products during this time period for the class/subclass.There were 7 complaints confirmed to have a manufacturing process root cause for a complaint of cells damaged/leaking.The complaints were evaluated to identify any potential trend.The calculated complaints per million produced (cpmp) result of 674 complaints was above the upper control limit (ucl) of 14 complaints per sop-105746 "complaint trending guideline", effective 05 feb 2019.An evaluation of the 36 month trend chart did not show a significant increase over time.Based on this pcom search, there is not a trend identified for the subclass of cells damaged/leaking for lower back and hip products.This complaint could not be associated with the confirmed ones as there is limited information.There is no further action required.Investigation summary: 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.Severity ranking was s3.Follow-up (17apr2019 and 22apr2019): new information received from the product quality complaint group included investigational results., comment: based on the available information, the patient identified that the heatwrap has split at the bottom felt like gravel in my trousers.No adverse event was associated with the use of the device.This single event malfunction has a theoretical risk to cause skin burn.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 remedial action/corrective action/field safety corrective action 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: 8518681
• MDR Text Key: 152807297
• Report Number: 1066015-2019-00110
• 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: 04/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/16/2019
• Is this an Adverse Event Report?: Yes
• 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