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

Device Problem Leak/Splash (1354)

Patient Problem Chemical Exposure (2570)

Event Type  malfunction  

Event Description

Event verbatim [preferred term] the heat cells (thermacare menstrual heat wrap) bursted open and got on to her (consumer) vaginal area [device leakage] , the heat cells (thermacare menstrual heat wrap) bursted open and got on to her (consumer) vaginal area [accidental exposure to product] ,.Case narrative:this is a spontaneous report from a contactable consumer reporting on behalf of his girlfriend.A (b)(6) female patient started to receive thermacare heatwrap (thermacare menstrual), on (b)(6) 2018 for menstrual cycle, she was having cramps.There was no medical history and no concomitant medications.The patient used thermacare menstrual on (b)(6) 2018.This was actually a first time using it, she only used one.When she used the heat cells, they bursted open and got on to her vaginal area on (b)(6) 2018.The reporter wasn't able to provide lot# and expiration date because they threw the heat wraps and box away, and all of the packaging.There was no lab work and no medical intervention.The action taken in response to the event for thermacare heatwrap and the event outcome were unknown.Additional information has been requested and will be provided as it becomes available.Follow-up (08mar2019): follow-up attempts are completed.No further information is expected.Follow-up (10apr2018): this follow-up report is being submitted to upgrade this case to a reportable medical device report.Company clinical evaluation comment the event "they bursted open and got on to her vaginal area " (device leakage) and (accidental exposure to product) were 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 events were assessed as associated with the use of the device., comment: the event "they bursted open and got on to her vaginal area " (device leakage) and (accidental exposure to product) were 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 events were assessed as associated with the use of the device.

Event Description

Event verbatim [preferred term] the heat cells (thermacare menstrual heat wrap) burst open and got on to her (consumer) vaginal area [accidental exposure to product] , the heat cells (thermacare menstrual heat wrap) bursted open and got on to her (consumer) vaginal area [device leakage].Case narrative:this is a spontaneous report from a contactable consumer reporting on behalf of his girlfriend.A 21-year-old female patient started to receive thermacare heatwrap (thermacare menstrual), on (b)(6) 2018 for menstrual cycle, she was having cramps.There was no medical history and no concomitant medications.The patient used thermacare menstrual on (b)(6) 2018.This was actually a first time using it, she only used one.When she used the heat cells, they bursted open and got on to her vaginal area on (b)(6) 2018.The reporter wasn't able to provide lot# and expiration date because they threw the heat wraps and box away, and all of the packaging.There was no lab work and no medical intervention.The action taken in response to the event for thermacare heatwrap and the event outcome were unknown.According to product quality complaints, reasonably suggest device malfunction: yes.Severity of harm: s3.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.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.Follow-up (08mar2019): follow-up attempts are completed.No further information is expected.Follow-up (10apr2018): this follow-up report is being submitted to upgrade this case to a reportable medical device report.Follow up (12nov2019): new information received from product quality complaints includes: malfunction assessment and severity of harm ranking.Follow up (21nov2019): new information received from product quality complaints includes: investigation results, impact analysis and severity rating.Company clinical evaluation comment: the events "they bursted open and got on to her vaginal area " (device leakage) and (accidental exposure to product) were 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 events were 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.No remedial action/corrective action/field safety corrective action is suggested at this time., comment: the events "they bursted open and got on to her vaginal area " (device leakage) and (accidental exposure to product) were 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 events were 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.No remedial action/corrective action/field safety corrective action is suggested at this time.

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.

Event Description

Event verbatim [preferred term] the heat cells (thermacare menstrual heat wrap) burst open and got on to her (consumer) vaginal area [device leakage] , the heat cells (thermacare menstrual heat wrap) burst open and got on to her (consumer) vaginal area [accidental exposure to product].Case narrative:this is a spontaneous report from a contactable consumer reporting on behalf of his girlfriend.A 21-year-old female patient started to receive thermacare heatwrap (thermacare menstrual), on (b)(6) 2018 for menstrual cycle, she was having cramps.There was no medical history and no concomitant medications.The patient used thermacare menstrual on (b)(6) 2018.This was actually a first time using it, she only used one.When she used the heat cells, they burst open and got on to her vaginal area on (b)(6) 2018.The reporter wasn't able to provide lot# and expiration date because they threw the heat wraps and box away, and all of the packaging.There was no lab work and no medical intervention.The action taken in response to the event for thermacare heatwrap and the event outcome were unknown.According to product quality complaints, reasonably suggest device malfunction: yes.Severity of harm: s3.Additional information has been requested and will be provided as it becomes available.Follow-up (08mar2019): follow-up attempts are completed.No further information is expected.Follow-up (10apr2018): this follow-up report is being submitted to upgrade this case to a reportable medical device report.Follow up (12nov2019): new information received from product quality complaints includes: malfunction assessment and severity of harm ranking.Company clinical evaluation comment: the event "they burst open and got on to her vaginal area " (device leakage) and (accidental exposure to product) were 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 events were assessed as associated with the use of the device., comment: the event "they burst open and got on to her vaginal area " (device leakage) and (accidental exposure to product) were 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 events were assessed as associated with the use of the device.

• 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: 9259999
• MDR Text Key: 220278436
• Report Number: 1066015-2019-00344
• 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: 04/10/2018

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
• 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: 11/27/2019; 12/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 21 YR