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

PFIZER CONSUMER HEALTH CARE THERMACARE MENSTRUAL; DISPOSABLE PACK, HOT

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Lot Number W36662

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Erythema (1840); Pain (1994); Cramp(s) (2193)

Event Date 12/01/2018

Event Type Injury

Event Description

Event verbatim [preferred term]: raised redness in the pattern of the heatwrap and a blister that popped [blister], raised redness in the pattern of the heatwrap and a blister that popped [erythema], she felt a bad stinging [pain].Case narrative: this is a spontaneous report from a contactable consumer (patient).A (b)(6) female patient started to receive thermacare heatwrap (thermacare menstrual), device lot number w36662, expiration date apr2021, (b)(4), on (b)(6) 2018 or (b)(6) 2018 used in 1 day for 7 hours approximately (8am until 3pm) for menstrual cramps.The patient medical history was not reported.Concomitant medication included ibuprofen, paracetamol (b)(6) strength 500mg, 2 tablets daily for menstrual cramps.The patient has used thermacare heatwrap about 10 years and did not experience the same problem/symptom below.The patient previously used other heat products for pain relief (electric heating pad, hot water bottle, microwave gel pack) and did not experience a problem/symptom.She used the product on her skin when she got up around 8am and was wearing leggings and a tee shirt.She worked from home.Around 3pm she felt a bad stinging and went to the bathroom to check under the heatwrap.She experienced raised redness in the pattern of the heatwrap and a blister that popped.The raised redness resolved, but the popped blister got pretty bad/started looking worse like it was infected.She was going to go to urgent care, but her mom is a retired nurse and she sent her a picture.Her mom told her to keep it clean and use (b)(6) and a bandage.It has since improved.The patient is not currently under the care of a physician for any medical condition.The patient classifies her skin tone as very light or fair.She does not have sensitive skin and abnormal skin.The color of the box you purchased was red box.She attached the adhesive to body.She did not engage in exercise while using the product.She did check her skin under the product while wearing thermacare.She read the usage instructions on thermacare before she used the product.She did consult a healthcare professional (her mother is a retired nurse) for the problem(s)/symptom(s).The action taken in response to the events for thermacare heatwrap was permanently withdrawn on (b)(6) 2018 or (b)(6) 2018.The outcome of raised redness in the pattern of the heatwrap and a blister that popped, she felt a bad stinging was resolving.The outcome of other event was unknown.Device was available for evaluation, she has one wrap remaining.The packaging was sealed and intact.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 blister, erythema and pain as described are considered serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure.The events are medically assessed as associated with the use of the device., comment: based on the information provided, the events of blister, erythema and pain as described are considered serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure.The events are medically assessed as associated with the use of the device.

Manufacturer Narrative

Investigation summary: the root cause category is non-assignable (complaint not confirmed).After a review of the batch thermal records, thermal results all met product release criteria.Consumer reports she received "raised redness and a blister" from a wrap.The cause of the raised redness and a blister" 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.The product quality for the batch is not impacted by this complaint.Process related: no; complaint confirmed: no.

Event Description

Raised redness in the pattern of the heatwrap and a blister that popped [blister], raised redness in the pattern of the heatwrap and a blister that popped [erythema], she felt a bad stinging [pain].Case narrative:this is a spontaneous report from a contactable consumer (patient).A 44-year-old female patient started to receive thermacare heatwrap (thermacare menstrual), device lot number: w36662, expiration date apr2021, upc number: 305733020029, on (b)(6) 2018 or on (b)(6) 2018 used in 1 day for 7 hours approximately (8am until 3pm) for menstrual cramps.The patient medical history was not reported.Concomitant medication included ibuprofen, paracetamol (midol) strength 500mg, 2 tablets daily for menstrual cramps.The patient has used thermacare heatwrap about 10 years and did not experience the same problem/symptom below.The patient previously used other heat products for pain relief (electric heating pad, hot water bottle, microwave gel pack) and did not experience a problem/symptom.She used the product on her skin when she got up around 8am and was wearing leggings and a tee shirt.She worked from home.Around 3pm she felt a bad stinging and went to the bathroom to check under the heatwrap.She experienced raised redness in the pattern of the heatwrap and a blister that popped.The raised redness resolved, but the popped blister got pretty bad/started looking worse like it was infected.She was going to go to urgent care, but her mom is a retired nurse and she sent her a picture.Her mom told her to keep it clean and use neosporin and a bandage.It has since improved.The patient is not currently under the care of a physician for any medical condition.The patient classifies her skin tone as very light or fair.She does not have sensitive skin and abnormal skin.The color of the box you purchased was red box.She attached the adhesive to body.She did not engage in exercise while using the product.She did check her skin under the product while wearing thermacare.She read the usage instructions on thermacare before she used the product.She did consult a healthcare professional (her mother is a retired nurse) for the problem(s)/symptom(s).The action taken in response to the events for thermacare heatwrap was permanently withdrawn on (b)(6) 2018 or on (b)(6) 2018.The outcome of raised redness in the pattern of the heatwrap and a blister that popped, she felt a bad stinging was resolving.The outcome of other event was unknown.Device was available for evaluation, she has one wrap remaining.The packaging was sealed and intact.Upon follow-up, product quality complaint group provided the following investigation summary: the root cause category is non-assignable (complaint not confirmed).After a review of the batch thermal records, thermal results all met product release criteria.Consumer reports she received "raised redness and a blister" from a wrap.The cause of the raised redness and a blister" 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.The product quality for the batch is not impacted by this complaint.Process related: no; complaint confirmed: no.Additional information has been requested and will be provided as it becomes available.Follow-up (24jan2019): new information from the product quality complaint group includes: investigation summary.Company clinical evaluation comment: based on the information provided, the events of blister, erythema and pain as described are considered serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure.The events are 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 events of blister, erythema and pain as described are considered serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure.The events are 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

Event Description

Event verbatim [preferred term] a blister that popped [blister] , raised redness in the pattern of the heatwrap [erythema] , she felt a bad stinging [pain] ,.Case narrative:this is a spontaneous report from a contactable consumer (patient).A 44-year-old female patient started to receive thermacare heatwrap (thermacare menstrual), device lot number w36662, expiration date 30apr2021, udi number: (b)(4), on (b)(6) 2018 or (b)(6) 2018 used in 1 day for 7 hours approximately (8am until 3pm) for menstrual cramps.The patient medical history included menstrual cramps.Concomitant medication included ibuprofen, paracetamol (midol) strength 500mg, 2 tablets daily for menstrual cramps.The patient had used thermacare heatwraps about 10 years and did not experience the same problem/symptom below.The patient previously used other heat products for pain relief (electric heating pad, hot water bottle, microwave gel pack) and did not experience a problem/symptom.She used the product when she got up around 8am and was wearing leggings and a tee shirt.She worked from home.Around 3pm she felt a bad stinging and went to the bathroom to check under the heatwrap.She experienced raised redness in the pattern of the heatwrap and a blister that popped in (b)(6) 2018.The raised redness resolved, but the popped blister got pretty bad/started looking worse like it was infected.She was going to go to urgent care, but her mom was a retired nurse and she sent her a picture.Her mom told her to keep it clean and used neosporin and a bandage.It had since improved.The patient was not currently under the care of a physician for any medical condition.The patient classified her skin tone as very light or fair.She did not have sensitive skin and abnormal skin.The color of the box she purchased was red.The patient reported that she followed the directions on how you were supposed to attach it and she was wearing leggings and a t-shirt as clothing.The patient did not provide that she had the heat wrap attached to her body.She did not engage in exercise while using the product.She did check her skin under the product while wearing thermacare.She read the usage instructions on thermacare before she used the product.She did consult a healthcare professional (her mother was a retired nurse) for the problem.The action taken in response to the events for thermacare heatwrap was permanently withdrawn on (b)(6) 2018 or (b)(6) 2018.The outcome of event raised redness in the pattern of the heatwrap was resolved.The outcome of the other events was resolving.Device was available for evaluation, she had one wrap remaining.The packaging was sealed and intact.Product quality complaint group provided the following investigation summary: the root cause category is non-assignable (complaint not confirmed).After a review of the batch thermal records, thermal results all met product release criteria.Consumer reports she received "raised redness and a blister" from a wrap.The cause of the raised redness and a blister" 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.The product quality for the batch is not impacted by this complaint.Process related: no; complaint confirmed: no.Follow-up (24jan2019): new information from the product quality complaint group includes: investigation summary.Follow-up (17apr2019): follow-up attempts are completed.No further information is expected.Follow-up (30jul2019): new information received in response to the confirmation regarding if the patient attached the adhesive to body: it was confirmed that "the patient reported that she followed the directions on how you are supposed to attach it and she was wearing leggings and a t-shirt as clothing.The patient did not provide that she had the heat wrap attached to her body".Narrative was updated.Follow-up attempts are completed.No further information is expected.Follow-up (06aug2019): new information received from the product quality complaint group includes updated expiration date.Follow-up attempts are completed.No further information is expected.Company clinical evaluation comment: based on the information provided, the events of blister, erythema and pain as described are considered serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure.The events are 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 events of blister, erythema and pain as described are considered serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure.The events are 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] a blister that popped [blister] , raised redness in the pattern of the heatwrap [erythema] , she felt a bad stinging [pain] ,.Case narrative:this is a spontaneous report from a contactable consumer (patient).A 44-year-old female patient started to receive thermacare heatwrap (thermacare menstrual), device lot number w36662, expiration date apr2021, upc number: 305733020029, on 04dec2018 or 05dec2018 used in 1 day for 7 hours approximately (8am until 3pm) for menstrual cramps.The patient medical history included menstrual cramps.Concomitant medication included ibuprofen, paracetamol (midol) strength 500mg, 2 tablets daily for menstrual cramps.The patient has used thermacare heatwraps about 10 years and did not experience the same problem/symptom below.The patient previously used other heat products for pain relief (electric heating pad, hot water bottle, microwave gel pack) and did not experience a problem/symptom.She used the product on her skin when she got up around 8am and was wearing leggings and a tee shirt.She worked from home.Around 3pm she felt a bad stinging and went to the bathroom to check under the heatwrap.She experienced raised redness in the pattern of the heatwrap and a blister that popped.The raised redness resolved, but the popped blister got pretty bad/started looking worse like it was infected.She was going to go to urgent care, but her mom is a retired nurse and she sent her a picture.Her mom told her to keep it clean and use neosporin and a bandage.It has since improved.The patient is not currently under the care of a physician for any medical condition.The patient classifies her skin tone as very light or fair.She does not have sensitive skin and abnormal skin.The color of the box you purchased was red box.The patient reported that she followed the directions on how you are supposed to attach it and she was wearing leggings and a t-shirt as clothing.The patient did not provide that she had the heat wrap attached to her body.She did not engage in exercise while using the product.She did check her skin under the product while wearing thermacare.She read the usage instructions on thermacare before she used the product.She did consult a healthcare professional (her mother is a retired nurse) for the problem(s)/symptom(s).The action taken in response to the events for thermacare heatwrap was permanently withdrawn on 04dec2018 or 05dec2018.The outcome of event raised redness in the pattern of the heatwrap was recovered.The outcome of the other events was resolving.Device was available for evaluation, she has one wrap remaining.The packaging was sealed and intact.Upon follow-up, product quality complaint group provided the following investigation summary: the root cause category is non-assignable (complaint not confirmed).After a review of the batch thermal records, thermal results all met product release criteria.Consumer reports she received "raised redness and a blister" from a wrap.The cause of the raised redness and a blister" 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.The product quality for the batch is not impacted by this complaint.Process related: no; complaint confirmed: no.Follow-up (24jan2019): new information from the product quality complaint group includes: investigation summary.Follow-up (17apr2019): follow-up attempts are completed.No further information is expected.Follow-up (30jul2019): new information received in response to the confirmation regarding if the patient attached the adhesive to body: it was confirmed that "the patient reported that she followed the directions on how you are supposed to attach it and she was wearing leggings and a t-shirt as clothing.The patient did not provide that she had the heat wrap attached to her body".Narrative was updated.Follow-up attempts are completed.No further information is expected.Company clinical evaluation comment: based on the information provided, the events of blister, erythema and pain as described are considered serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure.The events are 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 events of blister, erythema and pain as described are considered serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure.The events are 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

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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

8206591

MDR Text Key

131788481

Report Number

1066015-2018-00216

Device Sequence Number

Product Code

IMD

UDI-Device Identifier

00305733020029

UDI-Public

305733020029

Combination Product (y/n)

PMA/PMN Number

K953442

Number of Events Reported

Summary Report (Y/N)

Report Source

Manufacturer

Source Type

consumer

Type of Report

Initial,Followup,Followup,Followup

Report Date

12/20/2018

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?

Device Operator

Lay User/Patient

Device Expiration Date

04/30/2021

Device Lot Number

W36662

Was Device Available for Evaluation?

Yes

Initial Date Manufacturer Received

Not provided

Initial Date FDA Received

12/31/2018

Supplement Dates Manufacturer Received

Not provided
Not provided
Not provided

Supplement Dates FDA Received

01/31/2019
08/12/2019
08/20/2019

Is This a Reprocessed and Reused Single-Use Device?

Patient Sequence Number

Treatment

MIDOL [IBUPROFEN,PARACETAMOL].; MIDOL [IBUPROFEN,PARACETAMOL].; MIDOL [IBUPROFEN,PARACETAMOL].; MIDOL [IBUPROFEN,PARACETAMOL].

Patient Outcome(s)

Required Intervention;

Patient Age

44 YR

Patient Weight

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

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