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

Lot Number (L)S70434; (L)S68523

Device Problem Insufficient Information (3190)

Patient Problems Cramp(s) (2193); Partial thickness (Second Degree) Burn (2694)

Event Date 09/21/2018

Event Type  Injury  

Event Description

Event verbatim [preferred term] horrible burns [burns second degree].Case narrative: this is a spontaneous report from a contactable consumer.A female patient of an unspecified age started to receive thermacare heatwrap (thermacare menstrual), lot (l) s70434/expiration: mar2020 lot (l) s68523/ expiration: apr2020, on (b)(6) 2018 for an unspecified indication.Medical history and concomitant medications were not reported.The patient reported "i put it on my tank top and then tuck in my shirt and it ended up in the cramping area and when i went to use the bathroom 4 hours later i had horrible burns" on (b)(6) 2018.The patient further reported "i don't know how i got burns when i didn't bunch it up and wasn't on my skin at all" the action taken in response to the event for thermacare heatwrap and the outcome of the event was unknown.This report has been assessed as serious and reportable.Additional information has been requested and will be provided as it becomes available.Company clinical evaluation comment: based on the information provided, the event of "burns second degree" as described is considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.The event is medically assessed as associated with the use of the device.Comment: based on the information provided, the event of "burns second degree" as described is considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.The event is medically assessed as associated with the use of the device.

Manufacturer Narrative

The root cause category is non assignable (complaint not confirmed).Complaint is the result of an adverse event (a burn).The cause of the burn is inconclusive since review of records does not provide evidence to support defective product.The product effect may vary with each individual.The root cause category is non-assignable (complaint not confirmed).Our 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.No quality issues were identified upon this review of the batch device history record, in process attributes and variable quality checks or, inspection of retained samples.Retained samples met the product description and the product is within expiration date.The product quality for the batch is not impacted by this complaint.

Event Description

Event verbatim [preferred term] horrible burns [burns second degree] ,.Case narrative:this is a spontaneous report from a contactable consumer.A female patient of an unspecified age started to receive thermacare heatwrap (thermacare menstrual), lot (l) s70434/expiration: mar2020 lot (l) s68523/ expiration: apr2020, upc 305733020449, on 21sep2018 for an unspecified indication.Medical history and concomitant medications were not reported.The patient reported "i put it on my tank top and then tuck in my shirt and it ended up in the cramping area and when i went to use the bathroom 4 hours later i had horrible burns" on (b)(6) 2018.The patient further reported "i don't know how i got burns when i didn't bunch it up and wasn't on my skin at all" the action taken in response to the event for thermacare heatwrap and the outcome of the event was unknown.According to investigation report from product quality complaints for s70434 and s68523, the root cause category is non assignable (complaint not confirmed).Complaint is the result of an adverse event (a burn).The cause of the burn is inconclusive since review of records does not provide evidence to support defective product.The product effect may vary with each individual.The root cause category is non-assignable (complaint not confirmed).Our 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.No quality issues were identified upon this review of the batch device history record, in process attributes and variable quality checks or, inspection of retained samples.Retained samples met the product description and the product is within expiration date.The product quality for the batch is not impacted by this complaint.This report has been assessed as serious and reportable.Follow-up (28apr2019): follow-up attempts are completed.No further information is expected.Follow-up (29may2019): new information received from product quality complaints group included: investigation results.Follow-up (03jun2019): new information received from product quality complaints group included: additional investigation results for lot s68523.Company clinical evaluation comment based on the information provided, the event of "burns second degree" as described is considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.The event is medically assessed as associated with the use of the device.The review of the lot/batch records does not suggest a defect or quality issue related to the manufacture of this lot.No device malfunction has been identified.No remedial action/corrective action/field safety corrective action is suggested at this time., comment: based on the information provided, the event of "burns second degree" as described is considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.The event is medically assessed as associated with the use of the device.The review of the lot/batch records does not suggest a defect or quality issue related to the manufacture of this lot.No device malfunction has been identified.No remedial action/corrective action/field safety corrective action is suggested at this time.

Event Description

Event verbatim [preferred term] horrible burns [burns second degree] ,.Case narrative:this is a spontaneous report from a contactable consumer.A female patient of an unspecified age started to receive thermacare heatwrap (thermacare menstrual), lot (l) s70434/expiration: mar2020 lot (l) s68523/ expiration: apr2020, on 21sep2018 for an unspecified indication.Medical history and concomitant medications were not reported.The patient reported "i put it on my tank top and then tuck in my shirt and it ended up in the cramping area and when i went to use the bathroom 4 hours later i had horrible burns" on (b)(6) 2018.The patient further reported "i don't know how i got burns when i didn't bunch it up and wasn't on my skin at all" the action taken in response to the event for thermacare heatwrap and the outcome of the event was unknown.According to investigation report from product quality complaints, the root cause category is non assignable (complaint not confirmed).Complaint is the result of an adverse event (a burn).The cause of the burn is inconclusive since review of records does not provide evidence to support defective product.The product effect may vary with each individual.The root cause category is non-assignable (complaint not confirmed).Our 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.No quality issues were identified upon this review of the batch device history record, in process attributes and variable quality checks or, inspection of retained samples.Retained samples met the product description and the product is within expiration date.The product quality for the batch is not impacted by this complaint.This report has been assessed as serious and reportable.Follow-up (28apr2019): follow-up attempts are completed.No further information is expected.Follow-up (29may2019): new information received from product quality complaints group included: investigation results.Company clinical evaluation comment based on the information provided, the event of "burns second degree" as described is considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.The event is medically assessed as associated with the use of the device.The review of the lot/batch records does not suggest a defect or quality issue related to the manufacture of this lot.No device malfunction has been identified.No remedial action/corrective action/field safety corrective action is suggested at this time., comment: based on the information provided, the event of "burns second degree" as described is considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.The event is medically assessed as associated with the use of the device.The review of the lot/batch records does not suggest a defect or quality issue related to the manufacture of this lot.No device malfunction has been identified.No remedial action/corrective action/field safety corrective action is suggested at this time.

Manufacturer Narrative

The root cause category is non assignable (complaint not confirmed).Complaint is the result of an adverse event (a burn).The cause of the burn is inconclusive since review of records does not provide evidence to support defective product.The product effect may vary with each individual.The root cause category is non-assignable (complaint not confirmed).Our 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.No quality issues were identified upon this review of the batch device history record, in process attributes and variable quality checks or, inspection of retained samples.Retained samples met the product description and the product is within expiration date.The product quality for the batch is not impacted by this complaint.

• 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: 8558481
• MDR Text Key: 143420387
• Report Number: 1066015-2019-00124
• Device Sequence Number: 1
• Product Code: IMD
• UDI-Device Identifier: 00305733020449
• UDI-Public: 305733020449
• 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: 09/21/2018

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?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/01/2020
• Device Lot Number: (L)S70434; (L)S68523
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/26/2019
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 06/05/2019; 06/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention