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

Lot Number S16666

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Emotional Changes (1831); Hemorrhage/Bleeding (1888); Menstrual Irregularities (1959); Scarring (2061); Skin Discoloration (2074); Burning Sensation (2146); Cramp(s) (2193); Anxiety (2328); Burn, Thermal (2530); Decreased Sensitivity (2683)

Event Date 06/27/2017

Event Type  Injury  

Event Description

Event verbatim [preferred term]; she got a really bad burn from it/she thought her insides were on fire/she didn't think it was going to scar, it did bleed though [thermal burn], she doesn't think it is going to scar, it did bleed though [haemorrhage], the patient had the following medical history conditions of poor circulation, difficulty feeling heat or pain on skin and commented lost feelings in under 75 degree weather [device use error] , started panicking [panic reaction] , got scared [scar].Case narrative:this is a spontaneous report from a contactable consumer.A (b)(6) year-old other ethnic european non-pregnant and non-post-menopausal female patient started to receive thermacare heatwrap (thermacare menstrual), device lot number s16666s01/25, expiration date dec2019, via an unspecified route of administration from an unspecified date to an unspecified date at unk for extremely bad menstrual pain/cramps.The patient was not currently under the care of a physician for any medical condition.The patient had the following medical history conditions of poor circulation, difficulty feeling heat or pain on skin and commented lost feelings in under 75 degree weather.The patient classified her skin tone as very light or fair, did not have sensitive skin, and did not have any abnormal skin conditions.The patient denied other medical history, concomitant medications, or investigations.The patient previously used the thermacare heatwraps for your knees and that one did justice for her, but this was the first time she had used the menstrual ones.She also previously usually took acetylsalicylic acid (midol) for her menstrual pain.The patient bought the package a few days before the report and used it today for the first time and it said to check skin frequently and she got a really bad burn from it on (b)(6) 2017.She was thinking about going and getting it checked out.She couldn't even keep it on for an hour and only had it on for about 35 minutes.She wanted to report it.She wasn't sure if we were aware, but she knew everybody had different skin and it was not going to work the same on every type of skin.She hadn't gone to the doctor for the problems/symptoms, but her mom was telling her to go.It was just a little burn.The burn was on her lower stomach, where the corner of the heatwrap was.It didn't hurt as much anymore, but in the beginning she thought that this was so dangerous.It was a burn, it was not something that was going away.Now she didn't feel her skin burning.She could see it there, but she didn't feel it.It was about the size of her finger tip.She would be scared to use it again.Her cramps would have to be really bad, it scared her, she thought her insides were on fire.She would consider this a permanent stop.She was fine, she felt fine, her mother was just over exaggerating and wanted her to call.She was glad she took it off when she did.The patient used the product just the way it explained.She stuck it to her panties.The box did state to not put anything holding it down and not to sleep with it, so she didn't.She had a loose dress on with it.It was the first time she was checking her skin when she saw the burn, so she took it off.She started panicking and got scared when she saw it on (b)(6) 2017.She didn't think it was going to scar, it did bleed though on (b)(6) 2017.It was probably because her body wasn't used to it.It could just be different skin types.Her friend told her about them and she used it just fine.Product strength and count size dispensed: pack of 3.The sample of the product was available to be returned.Action taken for thermacare heatwraps in response to the events was permanently discontinued on (b)(6) 2017.The outcomes for she got a really bad burn from it/she thought her insides were on fire/she didn't think it was going to scar, it did bleed though was resolving.The outcomes of events were unknown.Additional information has been requested and will be provided as it becomes available.Company clinical evaluation comment: based on the information provided, the events of "burn" "bleeding" "the patient was not currently under the care of a physician for any medical condition.The patient had the following medical history conditions of poor circulation, difficulty feeling heat or pain on skin and commented lost feelings in under 75 degree weather" as described are considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.The events of "started panicking and got scared" are non-serious.The events are medically assessed as associated with the use of the device.The device use error which most likely contributed to this incident., comment: based on the information provided, the events of "burn" "bleeding" "the patient was not currently under the care of a physician for any medical condition.The patient had the following medical history conditions of poor circulation, difficulty feeling heat or pain on skin and commented lost feelings in under 75 degree weather" as described are considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.The events of "started panicking and got scared" are non-serious.The events are medically assessed as associated with the use of the device.The device use error which most likely contributed to this incident.

Event Description

Event verbatim [preferred term] she got a really bad burn from it; she thought her insides were on fire [thermal burn] , she doesn't think it is going to scar, it did bleed though [haemorrhage] , the patient had the following medical history conditions of poor circulation, difficulty feeling heat or pain on skin and commented lost feelings in under 75 degree weather [device use error] , started panicking [panic reaction] , got scared [scar] ,.Case narrative:this is a spontaneous report from a contactable consumer.A (b)(6) non-pregnant and non-post-menopausal female patient started to receive thermacare heatwrap (thermacare menstrual), device lot number s16666s01/25, expiration date dec2019, via an unspecified route of administration from an unspecified date to an unspecified date at unk for extremely bad menstrual pain/cramps.The patient was not currently under the care of a physician for any medical condition.The patient had the following medical history conditions of poor circulation, difficulty feeling heat or pain on skin and commented lost feelings in under 75 degree weather.The patient classified her skin tone as very light or fair, did not have sensitive skin, and did not have any abnormal skin conditions.The patient denied other medical history, concomitant medications, or investigations.The patient previously used the thermacare heatwraps for your knees and that one did justice for her, but this was the first time she had used the menstrual ones.She also previously usually took acetylsalicylic acid (midol) for her menstrual pain.The patient bought the package a few days before the report and used it today for the first time and it said to check skin frequently and she got a really bad burn from it on (b)(6) 2017.She was thinking about going and getting it checked out.She couldn't even keep it on for an hour and only had it on for about 35 minutes.She wanted to report it.She wasn't sure if we were aware, but she knew everybody had different skin and it was not going to work the same on every type of skin.She hadn't gone to the doctor for the problems/symptoms, but her mom was telling her to go.It was just a little burn.The burn was on her lower stomach, where the corner of the heatwrap was.It didn't hurt as much anymore, but in the beginning she thought that this was so dangerous.It was a burn, it was not something that was going away.Now she didn't feel her skin burning.She could see it there, but she didn't feel it.It was about the size of her finger tip.She would be scared to use it again.Her cramps would have to be really bad, it scared her, she thought her insides were on fire.She would consider this a permanent stop.She was fine, she felt fine, her mother was just over exaggerating and wanted her to call.She was glad she took it off when she did.The patient used the product just the way it explained.She stuck it to her panties.The box did state to not put anything holding it down and not to sleep with it, so she didn't.She had a loose dress on with it.It was the first time she was checking her skin when she saw the burn, so she took it off.She started panicking and got scared when she saw it on (b)(6) 2017.She didn't think it was going to scar, it did bleed though on (b)(6) 2017.It was probably because her body wasn't used to it.It could just be different skin types.Her friend told her about them and she used it just fine.Product strength and count size dispensed: pack of 3.The sample of the product was available to be returned.Action taken for thermacare heatwraps in response to the events was permanently discontinued on (b)(6) 2017.The outcome of event she got a really bad burn from it; she thought her insides were on fire was resolving.The outcomes of the other events were unknown.Additional information has been requested and will be provided as it becomes available.Amendment: this follow-up report is being submitted to amend previously reported information: updated events verbatim term and outcomes statement in narrative.Company clinical evaluation comment: based on the information provided, the events of "burn" "bleeding" "the patient was not currently under the care of a physician for any medical condition.The patient had the following medical history conditions of poor circulation, difficulty feeling heat or pain on skin and commented lost feelings in under 75 degree weather" as described are considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.The events of "started panicking and got scared" are non-serious.The events are medically assessed as associated with the use of the device.The device use error which most likely contributed to this incident., comment: based on the information provided, the events of "burn" "bleeding" "the patient was not currently under the care of a physician for any medical condition.The patient had the following medical history conditions of poor circulation, difficulty feeling heat or pain on skin and commented lost feelings in under 75 degree weather" as described are considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.The events of "started panicking and got scared" are non-serious.The events are medically assessed as associated with the use of the device.The device use error which most likely contributed to this incident.

Manufacturer Narrative

The root cause category is non-assignable (complaint not confirmed).The consumer reports she "she got a really bad burn" when wearing a wrap, the cause of the alleged burn is inconclusive since review of records does not provide evidence to support defective product.The product effect may vary with each individual.The plant has reviewed this batch from a manufacturing perspective.No quality issues were identified upon this review of batch records, release testing data or, inspection of retained samples.Retained samples met the product description and the product is within expiration date.After a review of the batch thermal records, thermal results all met product release criteria as per spec-22087, effective date: 28nov2016.

Event Description

Event verbatim [preferred term] she got a really bad burn from it; she thought her insides were on fire [thermal burn] , she doesn't think it is going to scar, it did bleed though [haemorrhage] , the patient had the following medical history conditions of poor circulation, difficulty feeling heat or pain on skin and commented lost feelings in under 75 degree weather [device use error] , started panicking [panic reaction] , got scared [scar] ,.Case narrative:this is a spontaneous report from a contactable consumer.A (b)(6) other ethnic european non-pregnant and non-post-menopausal female patient started to use thermacare heatwrap (thermacare menstrual) (device lot number s16666, expiration date dec2019) from an unspecified date for extremely bad menstrual pain/cramps.The patient was not currently under the care of a physician for any medical condition.The patient had the following medical history conditions of poor circulation, difficulty feeling heat or pain on skin and commented lost feelings in under 75 degree weather.The patient classified her skin tone as very light or fair, did not have sensitive skin, and did not have any abnormal skin conditions.The patient denied other medical history, concomitant medications, or investigations.The patient previously used the thermacare heatwraps for your knees and that one did justice for her, but this was the first time she had used the menstrual ones.She also previously usually took acetylsalicylic acid (midol) for her menstrual pain.The patient bought the package a few days before the report and used it today for the first time and it said to check skin frequently and she got a really bad burn from it on (b)(6) 2017.She was thinking about going and getting it checked out.She couldn't even keep it on for an hour and only had it on for about 35 minutes.She wanted to report it.She wasn't sure if we were aware, but she knew everybody had different skin and it was not going to work the same on every type of skin.She hadn't gone to the doctor for the problems/symptoms, but her mom was telling her to go.It was just a little burn.The burn was on her lower stomach, where the corner of the heatwrap was.It didn't hurt as much anymore, but in the beginning she thought that this was so dangerous.It was a burn, it was not something that was going away.Now she didn't feel her skin burning.She could see it there, but she didn't feel it.It was about the size of her finger tip.She would be scared to use it again.Her cramps would have to be really bad, it scared her, she thought her insides were on fire.She would consider this a permanent stop.She was fine, she felt fine, her mother was just over exaggerating and wanted her to call.She was glad she took it off when she did.The patient used the product just the way it explained.She stuck it to her panties.The box did state to not put anything holding it down and not to sleep with it, so she didn't.She had a loose dress on with it.It was the first time she was checking her skin when she saw the burn, so she took it off.She started panicking and got scared when she saw it on (b)(6) 2017.She didn't think it was going to scar, it did bleed though on (b)(6) 2017.It was probably because her body wasn't used to it.It could just be different skin types.Her friend told her about them and she used it just fine.Product strength and count size dispensed: pack of 3.The sample of the product was available to be returned.Action taken for thermacare heatwraps in response to the events was permanently discontinued on (b)(6) 2017.The outcome of event she got a really bad burn from it; she thought her insides were on fire was resolving.The outcomes of the other events were unknown.Additional information received from product quality complaint (pqc) group included investigation results.The root cause category is non-assignable (complaint not confirmed).The consumer reports she "she got a really bad burn" when wearing a wrap, the cause of the alleged burn is inconclusive since review of records does not provide evidence to support defective product.The product effect may vary with each individual.The plant has reviewed this batch from a manufacturing perspective.No quality issues were identified upon this review of batch records, release testing data or, inspection of retained samples.Retained samples met the product description and the product is within expiration date.After a review of the batch thermal records, thermal results all met product release criteria as per spec-22087, effective date: 28nov2016.Additional information has been requested and will be provided as it becomes available.Amendment: this follow-up report is being submitted to amend previously reported information: updated events verbatim term and outcomes statement in narrative.Follow-up (30sep2017): follow-up attempts are completed.No further information is expected.Follow up (08jan2018): new information received from product quality complaints (pqc) group included: product quality investigation results.Follow-up attempts are completed.No further information is expected.Company clinical evaluation comment based on the information provided, the events of "burn" "bleeding" "the patient was not currently under the care of a physician for any medical condition.The patient had the following medical history conditions of poor circulation, difficulty feeling heat or pain on skin and commented lost feelings in under 75 degree weather" as described are considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.The events of "started panicking and got scared" are non-serious.The events are medically assessed as associated with the use of the device.The device use error which most likely contributed to this incident, comment: based on the information provided, the events of "burn" "bleeding" "the patient was not currently under the care of a physician for any medical condition.The patient had the following medical history conditions of poor circulation, difficulty feeling heat or pain on skin and commented lost feelings in under 75 degree weather" as described are considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.The events of "started panicking and got scared" are non-serious.The events are medically assessed as associated with the use of the device.The device use error which most likely contributed to this incident.

• Brand Name: THERMACARE MENSTRUAL
• Type of Device: DISPOSABLE PACK, HOT
• Manufacturer (Section D): PFIZER CONSUMER HEALTH CARE; 1231 wyandotte drive; albany GA 31705
• Manufacturer Contact: b green ; 235 e42nd street; new york, NY 10017
• MDR Report Key: 6697920
• MDR Text Key: 79521728
• Report Number: 1066015-2017-00118
• Device Sequence Number: 1
• Product Code: IMD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K953442
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 06/27/2017

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: 12/01/2019
• Device Lot Number: S16666
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/10/2017
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 07/27/2017; 02/05/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 23 YR
• Patient Weight: 47