MAUDE Adverse Event Report: PFIZER CONSUMER HEALTH CARE THERMACARE MENSTRUAL; DISPOSABLE PACK, HOT

Device Problem Unintended Ejection (1234)

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

Event Type  malfunction  

Event Description

Event verbatim [preferred term] menstrual heatwrap busted open, got onto the patient and her bed/ burst [device leakage] , used the menstrual heatwrap on her back [device use issue] ,.Case narrative:this is spontaneous report from a non-contactable consumer reporting for self.This female patient used thermacare (thermacare menstrual) on an unspecified date for on unspecified indication.Medical history and concomitant medications were not reported.The patient was wearing a thermacare menstrual heatwrap while she was sleeping and it burst in her bed.The menstrual heat wrap busted open and got onto the patient and her bed.She used the menstrual heatwrap on her back.The action taken with thermacare and the clinical outcome of the events were not reported.No follow-up attempts are possible.No further information is expected.Follow-up (04jan2018): this follow-up report is being submitted to upgrade this case to a reportable mdr.Company clinical evaluation comment the patient reported that menstrual heatwrap busted open, got onto the patient and her bed/ burst.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 menstrual heatwrap busted open, got onto the patient and her bed/ burst.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] menstrual heatwrap busted open, got onto the patient and her bed/ burst [device leakage] , used the menstrual heatwrap on her back [device use issue].Case narrative:this is spontaneous report from a non-contactable consumer reporting for self.This female patient used thermacare (thermacare menstrual) on an unspecified date on her back.Medical history and concomitant medications were not reported.The patient was wearing a thermacare menstrual heatwrap while she was sleeping, and it burst in her bed.The menstrual heat wrap busted open and got onto the patient and her bed.She used the menstrual heatwrap on her back.The action taken with thermacare and the clinical outcome of the events were not reported.New information received from product quality complaint group included: there is reasonable suspicion of a device malfunction.The impact is cell leakage and the severity is s3-skin burn- per (b)(4) 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 (04jan2018): this follow-up report is being submitted to upgrade this case to a reportable mdr.Follow-up (11nov2019): new information received from a product quality complaint group includes severity ranking.Company clinical evaluation comment: the patient reported that menstrual heatwrap busted open, got onto the patient and her bed/ burst.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 menstrual heatwrap busted open, got onto the patient and her bed/ burst.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] menstrual heatwrap busted open, got onto the patient and her bed/ burst [device leakage] , used the menstrual heatwrap on her back [device use issue].Case narrative:this is spontaneous report from a non-contactable consumer reporting for self.This female patient used thermacare (thermacare menstrual) on an unspecified date on her back.Medical history and concomitant medications were not reported.The patient was wearing a thermacare menstrual heatwrap while she was sleeping, and it burst in her bed.The menstrual heat wrap busted open and got onto the patient and her bed.She used the menstrual heatwrap on her back.The action taken with thermacare and the clinical outcome of the events were not reported.New information received from product quality complaint group included: 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.Summary of investigation: this investigation was conducted for an unknown lot number menstrual 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 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: a lot trend was not performed as the lot number is unknown.Follow-up (04jan2018): this follow-up report is being submitted to upgrade this case to a reportable mdr.Follow-up (11nov2019): new information received from a product quality complaint group includes severity ranking.No follow-up attempts are possible.No further information is expected.Follow-up (26nov2019): new information received from a product quality complaint group includes investigation results.Company clinical evaluation comment: the patient reported that menstrual heatwrap busted open, got onto the patient and her bed/ burst.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 event "device use issue" is non-serious.The events are medically 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., comment: the patient reported that menstrual heatwrap busted open, got onto the patient and her bed/ burst.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 event "device use issue" is non-serious.The events are medically 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.

Manufacturer Narrative

Summary of investigation: this investigation was conducted for an unknown lot number menstrual 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 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: a lot trend was not performed as the lot number is unknown.

• 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: 9261826
• MDR Text Key: 220259067
• Report Number: 1066015-2019-00465
• 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: 01/04/2018

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
• 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: 11/22/2019; 12/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1