MAUDE Adverse Event Report: PFIZER CONSUMER HEALTH CARE THERMACARE MENSTRUAL; 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] the contents came out in her sock and bed.[device leakage] , using the product on her foot [intentional device use issue] ,.Case narrative:this is a spontaneous report from a non-contactable consumer.A female patient of an unspecified age started to receive thermacare heatwrap (thermacare menstrual), on an unspecified date, for an unspecified indication.Medical history and concomitant medications were not reported.The patient stated that she was using the heatwrap on her foot and the contents came out in her sock and bed.The patient stated that her foot looked fine and it felt fine.The action taken with thermacare heatwrap and the outcome of the events was unknown.No follow up attempts are possible.No further information is expected.Follow-up (28dec2017): new information received from product quality complaints includes: this follow-up report is being submitted to upgrade this case to a reportable mdr.Company clinical evaluation comment the patient reported that the contents came out in her sock and bed.This is a single potential device malfunction which has a theoretical risk to cause skin burn.No other adverse event such as burn was associated with the use of the device.The events are medically assessed as associated with the use of the device.The company is conducting further review on this investigation and additional follow-up will be reported when the evaluation is completed., comment: the patient reported that the contents came out in her sock and bed.This is a single potential device malfunction which has a theoretical risk to cause skin burn.No other adverse event such as burn was associated with the use of the device.The events are medically assessed as associated with the use of the device.The company is conducting further review on this investigation and additional follow-up will be reported when the evaluation is completed.

Event Description

Event verbatim [preferred term] using the product on her foot [intentional device use issue] , the contents came out in her sock and bed.[device leakage].Case narrative:this is a spontaneous report from a non-contactable consumer.A female patient of an unspecified age started to receive thermacare heatwrap (thermacare menstrual), on an unspecified date, for an unspecified indication.Medical history and concomitant medications were not reported.The patient stated that she was using the heatwrap on her foot and the contents came out in her sock and bed.The patient stated that her foot looked fine and it felt fine.The action taken with thermacare heatwrap and the outcome of the events was unknown.Caller refused to provide information or transfer.No correspondence can be sent as there was no reporter information available.According to 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- # hazard analysis thermacare heat wrap product: 8 and 12 hour.Additional information has been requested and will be provided as it becomes available.Follow-up (28dec2017): new information received from product quality complaints includes: this follow-up report is being submitted to upgrade this case to a reportable mdr.Follow-up (12nov2019): new information received from product quality complaints group included: impact analysis and severity ranking.Company clinical evaluation comment: the patient reported that the contents came out in her sock and bed.This is a single potential device malfunction which has a theoretical risk to cause skin burn.No other adverse event such as burn was associated with the use of the device.The events are medically assessed as associated with the use of the device.The company is conducting further review on this investigation and additional follow-up will be reported when the evaluation is completed., comment: the patient reported that the contents came out in her sock and bed.This is a single potential device malfunction which has a theoretical risk to cause skin burn.No other adverse event such as burn was associated with the use of the device.The events are medically assessed as associated with the use of the device.The company is conducting further review on this investigation and additional follow-up will be reported when the evaluation is completed.

Manufacturer Narrative

Summary of investigation: this investigation was conducted for an unknown lot number of joint therapy/flexible use 8hr product.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.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.Lot trend assmt.& rationale: no lot number provided.

Event Description

Event verbatim [preferred term] using the product on her foot [intentional device use issue] , the contents came out in her sock and bed.[device leakage].Case narrative:this is a spontaneous report from a non-contactable consumer.A female patient of an unspecified age started to receive thermacare heatwrap (thermacare menstrual), on an unspecified date, for an unspecified indication.Medical history and concomitant medications were not reported.The patient stated that she was using the heatwrap on her foot and the contents came out in her sock and bed.The patient stated that her foot looked fine and it felt fine.The action taken with thermacare heatwrap and the outcome of the events was unknown.Caller refused to provide information or transfer.No correspondence can be sent as there was no reporter information available.According to 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- # hazard analysis thermacare heat wrap product: 8 and 12 hour.Summary of investigation: this investigation was conducted for an unknown lot number of joint therapy/flexible use 8hr product.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.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.Lot trend assmt.& rationale: no lot number provided.Follow-up (28dec2017): new information received from product quality complaints includes: this follow-up report is being submitted to upgrade this case to a reportable mdr.Follow-up (12nov2019): new information received from product quality complaints group included: impact analysis and severity ranking.Follow-up (15nov2019): new information received from a product quality complaint group included: investigation results.Company clinical evaluation comment: the patient reported that the contents came out in her sock and bed.This is a single potential device malfunction which has a theoretical risk to cause skin burn.No other adverse event such as burn was associated with the use of the device.The events are medically assessed as associated with the use of the device.The company is conducting further review on this investigation and additional follow-up will be reported when the evaluation is completed.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., comment: the patient reported that the contents came out in her sock and bed.This is a single potential device malfunction which has a theoretical risk to cause skin burn.No other adverse event such as burn was associated with the use of the device.The events are medically assessed as associated with the use of the device.The company is conducting further review on this investigation and additional follow-up will be reported when the evaluation is completed.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 MENSTRUAL
• Type of Device: DISPOSABLE PACK, HOT
• Manufacturer (Section D): PFIZER CONSUMER HEALTH CARE; 1231 wyandotte drive; albany GA 31705
• MDR Report Key: 9260663
• MDR Text Key: 220031851
• Report Number: 1066015-2019-00459
• 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: 12/28/2017

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
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/31/2019
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 11/21/2019; 12/02/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1