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

Device Problems Unintended Ejection (1234); Leak/Splash (1354)

Patient Problem Chemical Exposure (2570)

Event Type  malfunction  

Event Description

Event verbatim [preferred term] heatwrap leaked into her crotch area/pc: heatwrap leaked [accidental exposure to product] , heatwrap leaked into her crotch area/pc: heatwrap leaked [device leakage] ,.Case narrative:this is a spontaneous report from a contactable consumer reported for herself.A female patient of an unspecified age started to receive thermacare heatwrap (thermacare menstrual) from an unspecified date at an unspecified frequency for menstrual cramps.The patient medical history and concomitant medications were not reported.The patient was using the heatwrap for menstrual cramps and it leaked onto her hip area on an unspecified date.The patient clarified hip area to mean crotch area.The patient reported there is a warning on the back of the box that said that she needed to go seek professional help.The patient reported that she washed it off.The action taken in response to the event for thermacare was unknown.The device was available for evaluation.The event outcome was 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 (30 may2018): this follow-up report is being submitted to upgrade this case to a reportable mdr.Company clinical evaluation comment the events "heat wrap leaked into her crotch 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 which has a theoretical risk to cause skin burn.The events were assessed as associated with the use of the device., comment: the events "heat wrap leaked into her crotch 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 which 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] heatwrap leaked into her crotch area/pc: heatwrap leaked [accidental exposure to product], heatwrap leaked into her crotch area/pc: heatwrap leaked [device leakage], , narrative: this is a spontaneous report from a contactable consumer reported for herself.A female patient of an unspecified age started to receive thermacare heatwrap (thermacare menstrual) from an unspecified date at an unspecified frequency for menstrual cramps.The patient medical history and concomitant medications were not reported.The patient was using the heatwrap for menstrual cramps and it leaked onto her hip area on an unspecified date.The patient clarified hip area to mean crotch area.The patient reported there is a warning on the back of the box that said that she needed to go seek professional help.The patient reported that she washed it off.The action taken in response to the event for thermacare was unknown.The device was available for evaluation.The event outcome was unknown.According to product quality complaints, reasonably suggest device malfunction was yes.Severity of harm was s3.Site sample status was not received.This investigation was conducted for an unknown lot number menstrual 8hr product.There is not a product quality related trend identified for the subclass heat cells damaged/leaking.A lot trend was not performed as the lot number is unknown.Conclusion was as follows 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.Follow-up (08mar2019): follow-up attempts are completed.No further information is expected.Follow-up (30 may2018): this follow-up report is being submitted to upgrade this case to a reportable mdr.Follow-up (17feb2020): new information received from product quality complaints group includes investigation results.Event term accidental exposure to product was recoded to accidental exposure to product related to device use.No follow-up attempts are possible.No further information is expected.

Manufacturer Narrative

Site sample status was not received.This investigation was conducted for an unknown lot number menstrual 8hr product.There is not a product quality related trend identified for the subclass heat cells damaged/leaking.A lot trend was not performed as the lot number is unknown.Conclusion was as follows 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.

• 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: 9260328
• MDR Text Key: 220025260
• Report Number: 1066015-2019-00347
• 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
• Report Date: 05/30/2018

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?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/31/2019
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1