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

Device Problems Fail-Safe Design Failure (1222); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Partial thickness (Second Degree) Burn (2694)

Event Date 11/25/2016

Event Type  Injury  

Event Description

I was burned [thermal burn] , have a bad blister on my pelvis [blister] , i have endometriosis and they are the only way i can get through a day when i'm not home [product use issue].Case narrative:this is a spontaneous report from a contactable consumer.A female patient of an unspecified age and ethnicity started to receive (b)(4) heatwrap ((b)(4) menstrual) via an unspecified route of administration from an unspecified date for endometriosis.The patient medical history was not reported.The patient's concomitant medications were not reported.The patient reported that "hello, i use the menstrual heating pads every month.I have endometriosis and they are the only way i can get through a day when i'm not home.I love the product but this weekend i was burned and have a bad blister on my pelvis.I had to go to the doctor for treatment.I used as directed as i have for a long time.This is the first time this happened and i just wanted to make you aware." events outcome was unknown.Additional information has been requested and will be provided as it becomes available.Company clinical evaluation comment: based on the information provided, the reported events thermal burn and blister as described in this case are considered serious bodily injuries potentially requiring medical intervention to prevent permanent damage or impairment of body structure, assessed as associated with the use of the device.The other event product use in unapproved indication is assessed as associated with the device.Comment: based on the information provided, the reported events thermal burn and blister as described in this case are considered serious bodily injuries potentially requiring medical intervention to prevent permanent damage or impairment of body structure, assessed as associated with the use of the device.The other event product use in unapproved indication is assessed as associated with the device.

Event Description

I was burned/it burned my pelvis [thermal burn] , have a bad blister on my pelvis/have a blister from the burn [blister] , i have endometriosis and they are the only way i can get through a day when i'm not home [product use issue] ,.Case narrative:this is a spontaneous report from a contactable consumer.A female patient of an unspecified age and ethnicity started to receive thermacare heatwrap (thermacare menstrual) via an unspecified route of administration from an unspecified date for endometriosis.The patient medical history was not reported.Concomitant medication included ibuprofen 800mg, salbutamol (albuterol) inhaler and nebulizer solution.The patient reported that "hello, i use the menstrual heating pads every month.I have endometriosis and they are the only way i can get through a day when i'm not home.I love the product but this weekend i was burned and have a bad blister on my pelvis ((b)(6) 2016).I had to go to the doctor for treatment.I used as directed as i have for a long time.This is the first time this happened and i just wanted to make you aware." events outcome was unknown.Additional information has been requested and will be provided as it becomes available.Follow-up ((b)(6) 2016): new information received from a contactable consumer via us fda with regulatory authority report number mw5066466 included: concomitant drug information and events onset date.Company clinical evaluation comment based on the information provided, the reported events thermal burn and blister as described in this case are considered serious bodily injuries potentially requiring medical intervention to prevent permanent damage or impairment of body structure, assessed as associated with the use of the device.The other event product use in unapproved indication is assessed as associated with the device., comment: based on the information provided, the reported events thermal burn and blister as described in this case are considered serious bodily injuries potentially requiring medical intervention to prevent permanent damage or impairment of body structure, assessed as associated with the use of the device.The other event product use in unapproved indication is assessed as associated with the device.

Manufacturer Narrative

Summary of investigation: this investigation was conducted for an unknown lot number menstrual 8 hour product.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 adverse event safety request for investigation.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.

Event Description

Event verbatim [preferred term].I was burned/it burned my pelvis [thermal burn], have a bad blister on my pelvis/have a blister from the burn [blister], i have endometriosis and they are the only way i can get through a day when i'm not home [device use issue], , narrative: this is a spontaneous report from a contactable consumer and from a contactable consumer via us fda (regulatory authority report number mw5066466).A female patient of an unspecified age started to receive thermacare heatwrap (thermacare menstrual) from an unspecified date for endometriosis.The patient medical history was not reported.Concomitant medication included ibuprofen 800 mg at 800 mg (unknown frequency), salbutamol (albuterol) inhaler and nebulizer solution.The patient reported that "hello, i use the menstrual heating pads every month.I have endometriosis and they are the only way i can get through a day when i'm not home.I love the product but this weekend i was burned and have a bad blister on my pelvis (25nov2016).I had to go to the doctor for treatment.I used as directed as i have for a long time.This is the first time this happened and i just wanted to make you aware.".Action taken and events outcome were unknown.The product quality complaint group provided the following investigation results.Reasonably suggest device malfunction was no, severity of harm was not applicable and site sample status was not received.Summary of investigation: this investigation was conducted for an unknown lot number menstrual 8 hour product.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 adverse event safety request for investigation.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 (19dec2016): new information received from a contactable consumer via us fda with regulatory authority report number mw5066466 included: concomitant drug information and events onset date.Follow-up (27jan2017): follow-up attempts are completed.No further information is expected.Follow-up (26jun2020): new information received from the product quality complaint group included: investigation results.Follow-up attempts are completed.No further information is expected., comment: based on the information provided, the reported events thermal burn and blister as described in this case are considered serious bodily injuries potentially requiring medical intervention to prevent permanent damage or impairment of body structure, assessed as associated with the use of the device.The other event product use in unapproved indication is assessed as associated with 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: 6169293
• MDR Text Key: 62312831
• Report Number: 1066015-2016-00163
• 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: 11/30/2016

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?: No
• Device Operator: Lay User/Patient
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/13/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 12/22/2016; 06/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ALBUTEROL [DOSAGE FORM:].; IBUPROFEN [DOSAGE FORM:].
• Patient Outcome(s): Required Intervention