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

Lot Number L84042

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Bruise/Contusion (1754); Contusion (1787); Burning Sensation (2146); Burn, Thermal (2530)

Event Date 07/30/2015

Event Type  Injury  

Event Description

Severely bruised and burned [contusion].Severely bruised and burned [thermal burn] it felt hot like burning hot [burning sensation].Case description: this is a spontaneous report from a contactable consumer.This (b)(6) asian female patient started to use thermacare heatwrap (thermacare menstrual), device lot number l84042, expiration date mar2018, from (b)(6) 2015 to (b)(6) 2015 once for menstrual pain.The patient medical history was not reported.Concomitant medication included labetalol for six years for blood pressure.It was reported the patient bought a thermacare heat wrap menstrual pain therapy up to 8 hours for pain relief and she only applied for 8 minutes and she was severely bruised and burned and she had "photos" and it happened (b)(6) 2015, and she was crippled, very bruised and she only used it for 8 minutes and she does not know what would happen to anybody if they use up to 8 hours.The patient mentioned that it feels hot like burning hot, it's like bruise pain it's like severely bruised.The patient mentioned that when someone's lower abdominal is very thin, she mentioned that her lower abdominal skin as usually very thin so it could easily get burned it's not like shoulder or back, it's not like another part of the body.The action taken with thermacare heatwrap was permanently withdrawn on (b)(6) 2015.No treatment was received for the events.The outcome of the events was unknown.The patient mentioned that she does not have any of the following conditions like diabetes, poor circulation, heart disease and difficulty feeling heat or pain on your skin, rheumatoid arthritis, decreased sensation, or neuropathy.The patient mentioned that she had a medium skin color.The patient mentioned that she just had a normal skin.The patient mentioned that she don't have any abnormal skin conditions.The patient mentioned that she purchased the red box.The patient mentioned that she does not have any of the product remaining, she just returned it to the store.The patient mentioned that she started using the product on (b)(6) 2015 and she immediately stopped using the product.The patient mentioned that she hasn't used thermacare previously and she was worried about someone who uses it in their sleep for 8 hours, it would be very traumatic.The patient mentioned that she hasn't used previously any other heat products for pain relief like electric heating pad, hot water bottle, microwave gel pack but maybe she had used the traditional pillow heating with the microwave or rice bag and then microwave it.The patient mentioned that she hasn't had any problem with one of these products.Additional information has been requested and will be provided as it becomes available.

Manufacturer Narrative

No quality issues were identified upon this review of batch records, thermal test data or, inspection of retained samples.Retained samples met the product description and the product is within expiration date.Corrective action procedures for individual cell temperature were completed for run day one and two.Wrap samples were pulled from the same hour of production as the wrap with the out of specification thermal result.The resample wraps for run day one did not meet the required specification for thermal temperature; the finished product for that hour of production was scrapped.The resample wraps for run day two did meet the required specification for thermal temperature.All procedures were followed, and all criteria met; however, the possibility of this defect occurring is still present.In addition, there is no way to determine if the temperature of the actual wrap used by the customer was outside the thermal temperature in-process specification as "too hot" cannot be confirmed.Outside of the investigations discussed in this report, there was no other out of specification temperature events associated with this batch over the three day production run.

Event Description

Severely bruised and burned [thermal burn].Severely bruised and burned [contusion].It felt hot like burning hot [burning sensation].Case description: this is a spontaneous report from a contactable consumer.This (b)(6) asian female patient started to use thermacare heatwrap (thermacare menstrual) (device lot number: l84042, expiration date: mar2018) from (b)(6) 2015 once for menstrual pain.The patient's medical history was not reported.Concomitant medication included labetalol for six years for blood pressure.It was reported the patient bought a thermacare heat wrap menstrual pain therapy up to 8 hours for pain relief and she only applied for 8 minutes and she was severely bruised and burned.She stated she had "photos", it happened on (b)(6) 2015, and she was crippled, very bruised and she only used it for 8 minutes.The patient does not know what would happened to anybody if they use up to 8 hours.She reported it feels hot like burning hot, it's like bruise pain it's like severely bruised.The patient mentioned that when someone's lower abdominal is very thin, she mentioned that her lower abdominal skin as usually very thin so it could easily get burned it's not like shoulder or back, it's not like another part of the body.Action taken with thermacare heatwrap was permanently withdrawn on (b)(6) 2015.No treatment was received for the events.Clinical outcome of the events was unknown.The patient mentioned that she does not have any of the following conditions like diabetes, poor circulation, heart disease and difficulty feeling heat or pain on your skin, rheumatoid arthritis, decreased sensation, or neuropathy.The patient assessed her skin tone as medium.She mentioned that she just had a normal skin.The patient mentioned that she don't have any abnormal skin conditions.She reported she purchased the red box and she does not have any of the product remaining, she just returned it to the store.The patient mentioned that she started using the product on 30 july 2015 and she immediately stopped using the product.She indicated she hasn't used thermacare previously and she was worried about someone who uses it in their sleep for 8 hours, it would be very traumatic.The patient mentioned that she has not previously used other heat products for pain relief like electric heating pad, hot water bottle, microwave gel pack but maybe she had used the traditional pillow heating with the microwave or rice bag and then microwave it.The patient mentioned that she hasn't had any problem with one of these products.Additional information received from product quality complaint (pqc) group provided quality assurance (qa) investigation results.No quality issues were identified upon this review of batch records, thermal test data or, inspection of retained samples.Retained samples met the product description and the product is within expiration date.Corrective action procedures for individual cell temperature were completed for run day one and two.Wrap samples were pulled from the same hour of production as the wrap with the out of specification thermal result.The resample wraps for run day one did not meet the required specification for thermal temperature; the finished product for that hour of production was scrapped.The resample wraps for run day two did meet the required specification for thermal temperature.All procedures were followed, and all criteria met; however, the possibility of this defect occurring is still present.In addition, there is no way to determine if the temperature of the actual wrap used by the customer was outside the thermal temperature in-process specification as "too hot" cannot be confirmed.Outside of the investigations discussed in this report, there was no other out of specification temperature events associated with this batch over the three day production run.Additional information has been requested and will be provided as it becomes available.Follow up (19aug2015): new information received from product quality complaints (pqc) group included: quality assurance (qa) investigation results.Company clinical evaluation comment based on the information provided, the events severely bruised and burned as described in this case is considered a serious bodily injury 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 burning sensation is assessed as associated with device use.This case meets final 10-day eu and 30-day fda reportability.Case comment: based on the information provided, the events severely bruised and burned as described in this case is considered a serious bodily injury 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 burning sensation is assessed as associated with device use.This case meets final 10-day eu and 30-day fda reportability.Continued: evaluation summary no quality issues were identified upon this review of batch records, thermal test data or, inspection of retained samples.Retained samples met the product description and the product is within expiration date.Corrective action procedures for individual cell temperature were completed for run day one and two.Wrap samples were pulled from the same hour of production as the wrap with the out of specification thermal result.The resample wraps for run day one did not meet the required specification for thermal temperature; the finished product for that hour of production was scrapped.The resample wraps for run day two did meet the required specification for thermal temperature.All procedures were followed, and all criteria met; however, the possibility of this defect occurring is still present.In addition, there is no way to determine if the temperature of the actual wrap used by the customer was outside the thermal temperature in-process specification as "too hot" cannot be confirmed.Outside of the investigations discussed in this report, there was no other out of specification temperature events associated with this batch over the three day production run.

• Brand Name: THERMACARE MENSTRUAL
• Type of Device: DISPOSABLE PACK, HOT
• Manufacturer (Section D): PFIZER CONSUMER HEALTH CARE; albany GA
• Manufacturer (Section G): PFIZER CONSUMER HEALTH CARE; 1231 wyandotte drive; albany GA 31705
• Manufacturer Contact: 219 east 42nd street; new york, NY 10017 ; 2127335544
• MDR Report Key: 5008491
• MDR Text Key: 23227364
• Report Number: 1066015-2015-00103
• 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
• Report Date: 08/05/2015

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
• Device Expiration Date: 03/01/2018
• Device Lot Number: L84042
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/13/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 43 YR
• Patient Weight: 66