MAUDE Adverse Event Report: PFIZER CONSUMER HEALTH CARE THERMACARE HEATWRAPS MULTI-PURPOSE JOINT PAIN; DISPOSABLE PACK, HOT

Lot Number 05733017

Device Problems Leak/Splash (1354); Device Slipped (1584)

Patient Problem Foreign Body Sensation in Eye (1869)

Event Type  Injury  

Event Description

I got the scare of my life when i felt gritty grain on my buttock after taking heat wrap off [sensation of foreign body] , it had come loose [device leakage].Case narrative: this is a spontaneous report from a contactable consumer.An (b)(6) year-old female patient started to use thermacare heatwrap (thermacare heatwraps multi-purpose joint pain) (device lot #: 05733017) from an unspecified date and ongoing at unknown frequency for an unspecified indication.Medical history and concomitant medications were not reported.On an unspecified date, the patient returned the heatwrap in a zip lock bag and stated "i have used theramcare heatwraps with good results but this time i got the scare of my life when i felt gritty grain on my buttock after taking heat wrap off.It had come loose".She no longer had any product information.She had thrown the box and the outer wrapper away already.Device was not available for evaluation.The patient reported being hospitalized as a result of the event got the scare of her life when she felt gritty grain on her buttock after taking heat wrap off.No therapeutic measures were taken as a result of the event got the scare of her life when she felt gritty grain on her buttock after taking heat wrap off.The action taken in response to the events for thermacare heatwrap was dose not changed.The outcome of the events was resolved on an unspecified date.Follow-up (28nov2016): new information reported from a contactable consumer includes: suspect data (clarified as thermacare heatwraps multi-purpose joint pain).Follow-up (27dec2016): new information received from a contactable consumer includes: patient age, suspect product lot number, action taken with suspect product, patient hospitalization and events outcome.Follow-up attempts are completed.No further information is expected.Follow-up (03nov2016): this follow-up report is being submitted to upgrade this case to a reportable mdr.Company clinical evaluation comment: based on the available information, the events of "felt gritty grain on my buttock after taking heat wrap off" it had come loose" are considered serious requiring hospitalization.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.A causal relationship between the suspect device and the events cannot be ruled out., comment: based on the available information, the events of "felt gritty grain on my buttock after taking heat wrap off" it had come loose" are considered serious requiring hospitalization.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.A causal relationship between the suspect device and the events cannot be ruled out.

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 heat 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.Document review summary: there is no device history report (dhr) reviewed for an unknown batch number.Lot trend assmt.& rationale: a lot trend was not performed as the lot number is unknown.Pr state: closed.

Event Description

Event verbatim [preferred term] i got the scare of my life when i felt gritty grain on my buttock after taking heat wrap off [sensation of foreign body] , it had come loose [device leakage].Case narrative:this is a spontaneous report from a contactable consumer.An 82-year-old female patient started to use thermacare heatwrap (thermacare heatwraps multi-purpose joint pain) from an unspecified date and ongoing at unknown frequency for an unspecified indication.Medical history and concomitant medications were not reported.On an unspecified date, the patient returned the heatwrap in a zip lock bag and stated "i have used theramcare heatwraps with good results but this time i got the scare of my life when i felt gritty grain on my buttock after taking heat wrap off.It had come loose".She no longer had any product information.She had thrown the box and the outer wrapper away already.Device was not available for evaluation.The patient reported being hospitalized as a result of the event got the scare of her life when she felt gritty grain on her buttock after taking heat wrap off.No therapeutic measures were taken as a result of the event got the scare of her life when she felt gritty grain on her buttock after taking heat wrap off.The action taken in response to the events for thermacare heatwrap was dose not changed.The outcome of the events was resolved on an unspecified date.According to the product quality complaint group: reasonably suggest device malfunction was yes and severity of harm was s3 for complaint sub-class: heat cells damaged/leaking.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- 38832 hazard analysis thermacare heat wrap product: 8 and 12 hour.Manufactory site 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 heat 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.Lot trend assmt.& rationale: a lot trend was not performed as the lot number is unknown.Pr state: closed.Follow-up (28nov2016): new information reported from a contactable consumer includes: suspect data (clarified as thermacare heatwraps multi-purpose joint pain).Follow-up (27dec2016): new information received from a contactable consumer includes: patient age, suspect product lot number, action taken with suspect product, patient hospitalization and events outcome.Follow-up (03nov2016): this follow-up report is being submitted to upgrade this case to a reportable mdr.Follow-up (10nov2019): new information received from the product quality complaint group includes severity rating and malfunction assessment.Follow-up (11nov2019 and 13nov2019): new information received from the product quality complaint group includes: severity rating and malfunction assessment, investigation results from manufacturing site.Company clinical evaluation comment: based on the available information, the events of "felt gritty grain on my buttock after taking heat wrap off" it had come loose" are considered serious requiring hospitalization.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.A causal relationship between the suspect device and the events cannot be ruled out., comment: based on the available information, the events of "felt gritty grain on my buttock after taking heat wrap off" it had come loose" are considered serious requiring hospitalization.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.A causal relationship between the suspect device and the events cannot be ruled out.The review of the lot/batch records does not suggest a defect or quality issue related to the manufacture of this lot.No further investigations or actions is suggested at this time.

Event Description

Event verbatim [preferred term] i got the scare of my life when i felt gritty grain on my buttock after taking heat wrap off [sensation of foreign body] , it had come loose [device leakage] ,.Case narrative: this is a spontaneous report from a contactable consumer.An 82-year-old female patient started to use thermacare heatwrap (thermacare heatwraps multi-purpose joint pain) (device lot #: 05733017) from an unspecified date and ongoing at unknown frequency for an unspecified indication.Medical history and concomitant medications were not reported.On an unspecified date, the patient returned the heatwrap in a zip lock bag and stated "i have used theramcare heatwraps with good results but this time i got the scare of my life when i felt gritty grain on my buttock after taking heat wrap off.It had come loose".She no longer had any product information.She had thrown the box and the outer wrapper away already.Device was not available for evaluation.The patient reported being hospitalized as a result of the event got the scare of her life when she felt gritty grain on her buttock after taking heat wrap off.No therapeutic measures were taken as a result of the event got the scare of her life when she felt gritty grain on her buttock after taking heat wrap off.The action taken in response to the events for thermacare heatwrap was dose not changed.The outcome of the events was resolved on an unspecified date.According to the product quality complaint group: reasonably suggest device malfunction was yes and severity of harm was s3 for complaint sub-class: heat cells damaged/leaking.Additional information has been requested and will be provided as it becomes available.Follow-up (28nov2016): new information reported from a contactable consumer includes: suspect data (clarified as thermacare heatwraps multi-purpose joint pain).Follow-up (27dec2016): new information received from a contactable consumer includes: patient age, suspect product lot number, action taken with suspect product, patient hospitalization and events outcome.Follow-up (03nov2016): this follow-up report is being submitted to upgrade this case to a reportable mdr.Follow-up (10nov2019): new information received from the product quality complaint group includes severity rating and malfunction assessment.Company clinical evaluation comment: based on the available information, the events of "felt gritty grain on my buttock after taking heat wrap off" it had come loose" are considered serious requiring hospitalization.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.A causal relationship between the suspect device and the events cannot be ruled out., comment: based on the available information, the events of "felt gritty grain on my buttock after taking heat wrap off" it had come loose" are considered serious requiring hospitalization.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.A causal relationship between the suspect device and the events cannot be ruled out.

• Brand Name: THERMACARE HEATWRAPS MULTI-PURPOSE JOINT PAIN
• Type of Device: DISPOSABLE PACK, HOT
• Manufacturer (Section D): PFIZER CONSUMER HEALTH CARE; 1231 wyandotte drive; albany GA 31705
• MDR Report Key: 9257384
• MDR Text Key: 181964291
• Report Number: 1066015-2019-00317
• 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,Followup
• Report Date: 11/03/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Lot Number: 05733017
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/30/2019
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 11/15/2019; 12/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 82 YR