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

PFIZER CONSUMER HEALTH CARE THERMACARE MENSTRUAL; DISPOSABLE PACK, HOT

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

Patient Problems Burning Sensation (2146); Burn, Thermal (2530)

Event Date 12/12/2019

Event Type Injury

Event Description

Blisters/felt it burning/ location of the burn is to the left of her belly button on the lower part of the abdomen/her skin was really red [burns second degree].Case narrative: this is a spontaneous report from a contactable consumer.A (b)(6) non-pregnant female patient started to receive thermacare heatwrap (thermacare menstrual), lot number and expiration date not provided, upc (b)(4) from (b)(6) 2019 for cramping really bad.Medical history included sensitive skin, poor circulation, she wonders if she has difficulty feeling heat or pain on your skin, and rheumatoid arthritis.Concomitant medications included midol the equate brand, she took 2 of them, lot: p114644, expiry: mar2021.Past drug history included using thermacare knee for which no adverse event was reported.The patient previously took thermacare knee heatwraps and experienced no adverse event.The patient experienced blisters on (b)(6) 2019, her skin was really red on (b)(6) 2019, was a little sore on (b)(6) 2019, and felt it burning/ location of the burn is to the left of her belly button on the lower part of the abdomen on an unspecified date.The patient stated that she left it on for 8 hours and when she got home and checked the status of the patch, her skin was really red.Her skin was noticed to be really, really red and she was a little sore.Later she noticed her skin was blistered.On thursday, (b)(6) 2019 she only saw that her skin was really red.It was on friday, (b)(6) 2019 that the blisters were noticed.She states currently they are doing about the same.She has applied neosporin and burn cream for treatment.The patient is not currently under the care of a physician for any medical condition.Her skin tone was carmel colored and she does not have any abnormal skin conditions.The color of the box she purchased was red.She used heat pad and she normally sleeps on it, and actually used it after the experience with the thermacare heat wrap on the other side, the right side.The patient was wearing several layers of clothing over the thermacare product- a jacket and sweater.The patient did not engage in exercise while using the product.She did check her skin.She felt it burning and moved to the left side; she had been wearing about 1.5 hours before moving it.Afterward she checked it every 30 minutes as she felt her skin was pretty sore.She stated previously that she did wear the product 8 hours.The patient read the usage instructions on thermacare before she used the product.The location of the burn is to the left of her belly button on the lower part of the abdomen.The product was originally applied to the right side and there is a small area there.She confirms it is a blister and scarred but not as bad as the left.That looks like her skin is peeling off.She had been using thermacare that day for about 8 hours.She did not consult a healthcare professional for the problem(s)/symptom(s), but only went to the pharmacy at her job and spoke to a pharmacist who recommended the burn cream.The product was discarded by the patient.The action taken with thermacare heatwrap is permanently withdrawn.The outcome of the events were not recovered.Additional information has been requested and will be provided as it becomes available.Company clinical evaluation comment: based on the information provided, the event burns second degree as described is considered serious bodily injury 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 burns second degree as described is considered serious bodily injury 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.

Event Description

Manufacturer Narrative

Summary of investigation: this investigation was conducted for an unknown lot number menstrual 8hr product.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 trend identified related for the subclass adverse event/serious/unknown.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/serious/unknown.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.Lot trend assmt.& rationale: a lot trend was not performed as the lot number is unknown.The sample had not been received by the site.

Event Description

Event verbatim [preferred term] blisters/felt it burning/ location of the burn is to the left of her belly button on the lower part of the abdomen/her skin was really red [burns second degree] ,.Case narrative:this is a spontaneous report from a contactable consumer.A 33-year-old non-pregnant female patient started to receive thermacare heatwrap (thermacare menstrual), lot number and expiration date not provided, upc 305733020069 from (b)(6)2019 to(b)(6)2019 for cramping really bad.Medical history included sensitive skin, poor circulation, she wonders if she has difficulty feeling heat or pain on your skin, and rheumatoid arthritis.Concomitant medications included midol the equate brand, she took (b)(4) of them, lot: p114644, expiry: mar2021.Past drug history included using thermacare knee for which no adverse event was reported.The patient previously took thermacare knee heatwraps and experienced no adverse event.The patient experienced blisters on 13dec2019, her skin was really red on (b)(6)2019, was a little sore on (b)(6)2019, and felt it burning/ location of the burn is to the left of her belly button on the lower part of the abdomen.The patient stated that she left it on for 8 hours and when she got home and checked the status of the patch, her skin was really red.Her skin was noticed to be really, really red and she was a little sore.Later she noticed her skin was blistered.On thursday, (b)(6)2019 she only saw that her skin was really red.It was on friday, (b)(6)2019 that the blisters were noticed.She states currently they are doing about the same.She has applied neosporin and burn cream for treatment.The patient is not currently under the care of a physician for any medical condition.Her skin tone was carmel colored and she does not have any abnormal skin conditions.The color of the box she purchased was red.She used heat pad and she normally sleeps on it, and actually used it after the experience with the thermacare heat wrap on the other side, the right side.The patient was wearing several layers of clothing over the thermacare product- a jacket and sweater.The patient did not engage in exercise while using the product.She did check her skin.She felt it burning and moved to the left side; she had been wearing about 1.5 hours before moving it.Afterward she checked it every 30 minutes as she felt her skin was pretty sore.She stated previously that she did wear the product 8 hours.The patient read the usage instructions on thermacare before she used the product.The location of the burn is to the left of her belly button on the lower part of the abdomen.The product was originally applied to the right side and there is a small area there.She confirms it is a blister and scarred but not as bad as the left.That looks like her skin is peeling off.She had been using thermacare that day for about 8 hours.She did not consult a healthcare professional for the problem(s)/symptom(s), but only went to the pharmacy at her job and spoke to a pharmacist who recommended the burn cream.The product was discarded by the patient.The action taken with thermacare heatwrap is permanently withdrawn.The outcome of the events were not recovered.According to product quality complaint group: per dchu: severity of harm was reported as s3.Conclusion: a full investigation was not performed as providing the batch record information is the manufacturing site's requirement.Therefore, a summary investigation was performed.Based on the complaint narrative, the patient developed skin redness and blisters that caused pain after product use.Review of complaint description concludes there is no device malfunction.Per site: summary of investigation: this investigation was conducted for an unknown lot number menstrual 8hr product.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 trend identified related for the subclass adverse event/serious/unknown.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/serious/unknown.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.Lot trend assmt.& rationale: a lot trend was not performed as the lot number is unknown.The sample had not been received by the site.Follow-up (19dec2019): new information received from a product quality complaint group includes severity of harm and site sample was not received.Follow-up (20dec2019): new information received from a product quality complaint group includes investigation results.Company clinical evaluation comment: based on the information provided, the event burns second degree as described is considered serious bodily injury 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.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.Product effect varies with each individual.No remedial action/corrective action/field safety corrective action is suggested at this time., comment: based on the information provided, the event burns second degree as described is considered serious bodily injury 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.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.Product effect varies with each individual.No remedial action/corrective action/field safety corrective action is suggested at this time.

Event Description

Blisters/felt it burning/ location of the burn is to the left of her belly button on the lower part of the abdomen/her skin was really red [burns second degree].Case description: this is a spontaneous report from a contactable consumer.A 33-year-old non-pregnant female patient started to receive thermacare heatwrap (thermacare menstrual), lot number and expiration date not provided, upc 305733020069 from 11dec2019 to 12 dec2019 at 1 patch for 8 hours for cramping really bad, and to help with pain and cramp.Medical history included sensitive skin, poor circulation, she wonders if she has difficulty feeling heat or pain on your skin, and rheumatoid arthritis.Concomitant medications included midol the equate brand, she took 2 of them, lot: p114644, expiry: mar2021.Past drug history included using thermacare knee for which no adverse event was reported.The patient previously took thermacare knee heatwraps and experienced no adverse event.The patient experienced blisters on (b)(6) 2019, her skin was really red on (b)(6) 2019, was a little sore on (b)(6) 2019, and felt it burning/ location of the burn is to the left of her belly button on the lower part of the abdomen.The patient stated that she left it on for 8 hours and when she got home and checked the status of the patch, her skin was really red.Her skin was noticed to be really, really red and she was a little sore.Later she noticed her skin was blistered.On thursday, (b)(6) 2019 she only saw that her skin was really red.It was on friday, (b)(6) 2019 that the blisters were noticed.She states currently they are doing about the same.She has applied neosporin and burn cream for treatment.The patient is currently under the care of a physician for any medical condition.Her skin tone was carmel colored and she does not have any abnormal skin conditions.The color of the box she purchased was red.She used heat pad and she normally sleeps on it, and actually used it after the experience with the thermacare heat wrap on the other side, the right side.The patient previously used other heat products for pain relief (electric heating pad, hot water bottle, microwave gel pack) and has previously not experienced a problem/symptom with one of these products.The patient was wearing several layers of clothing over the thermacare product- a jacket and sweater.The patient did not engage in exercise while using the product.She did check her skin.She felt it burning and moved to the left side; she had been wearing about 1.5 hours before moving it.Afterward she checked it every 30 minutes as she felt her skin was pretty sore.She stated previously that she did wear the product 8 hours.The patient read the usage instructions on thermacare before she used the product.The location of the burn is to the left of her belly button on the lower part of the abdomen.The product was originally applied to the right side and there is a small area there.She confirms it is a blister and scarred but not as bad as the left.That looks like her skin is peeling off.She had been using thermacare that day for about 8 hours.She did not consult a healthcare professional for the problem(s)/symptom(s), but only went to the pharmacy at her job and spoke to a pharmacist who recommended the burn cream.The product was discarded by the patient.Upon follow-up on (b)(6) 2020, the following was reported: lab data of 22lbs, and height of 5'8.For event blister, there was no hospitalization, treatment was received.The patient stated skin is healing, but she has scars.The action taken with thermacare heatwrap is permanently withdrawn.The outcome of the event was not recovered.According to product quality complaint group: per dchu: severity of harm was reported as s3.Conclusion: a full investigation was not performed as providing the batch record information is the manufacturing site's requirement.Therefore, a summary investigation was performed.Based on the complaint narrative, the patient developed skin redness and blisters that caused pain after product use.Review of complaint description concludes there is no device malfunction.Per site: summary of investigation: this investigation was conducted for an unknown lot number menstrual 8hr product.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 trend identified related for the subclass adverse event/serious/unknown.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/serious/unknown.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.Lot trend assmt.& rationale: a lot trend was not performed as the lot number is unknown.The sample had not been received by the site.Follow-up ((b)(6) 2019): new information received from a product quality complaint group includes severity of harm and site sample was not received.Follow-up ((b)(6) 2019): new information received from a product quality complaint group includes investigation results.Follow-up ((b)(6) 2020): new information received from a contactable consumer includes: lab data, product information (added indication), no hospitalization involved, and event information.Follow-up attempts are completed.No further information is expected.Company clinical evaluation comment: based on the information provided, the event burns second degree as described is considered serious bodily injury 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.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.Product effect varies with each individual.No remedial action/corrective action/field safety corrective action is suggested at this time.

Manufacturer Narrative

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/serious/unknown.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].Blisters/felt it burning/ location of the burn is to the left of her belly button on the lower part of the abdomen/her skin was really red [burns second degree], narrative: this is a spontaneous report from a contactable consumer.A 33-year-old non-pregnant female patient started to use thermacare heatwrap (thermacare menstrual) (lot number and expiration date not provided, upc 305733020069) from (b)(6) 2019 to (b)(6) 2019 at 1 patch for 8 hours for cramping really bad, and to help with pain and cramp.Medical history included sensitive skin, poor circulation, she wonders if she has difficulty feeling heat or pain on your skin, and rheumatoid arthritis.Concomitant medications included midol the equate brand, she took 2 of them, lot: p114644, expiry: mar2021.Past drug history included using thermacare knee for which no adverse event was reported.The patient previously used thermacare knee heatwraps and experienced no adverse event.The patient experienced blisters on (b)(6) 2019, her skin was really red on (b)(6) 2019, was a little sore on (b)(6) 2019, and felt it burning/ location of the burn is to the left of her belly button on the lower part of the abdomen.The patient stated that she left it on for 8 hours and when she got home and checked the status of the patch, her skin was really red.Her skin was noticed to be really, really red and she was a little sore.Later she noticed her skin was blistered.On thursday, (b)(6) 2019 she only saw that her skin was really red.It was on friday, (b)(6) 2019 that the blisters were noticed.She states currently they are doing about the same.She has applied neosporin and burn cream for treatment.The patient is currently under the care of a physician for any medical condition.Her skin tone was carmel colored and she does not have any abnormal skin conditions.The color of the box she purchased was red.She used heat pad and she normally sleeps on it, and actually used it after the experience with the thermacare heat wrap on the other side, the right side.The patient previously used other heat products for pain relief (electric heating pad, hot water bottle, microwave gel pack) and has previously not experienced a problem/symptom with one of these products.The patient was wearing several layers of clothing over the thermacare product- a jacket and sweater.The patient did not engage in exercise while using the product.She did check her skin.She felt it burning and moved to the left side; she had been wearing about 1.5 hours before moving it.Afterward she checked it every 30 minutes as she felt her skin was pretty sore.She stated previously that she did wear the product 8 hours.The patient read the usage instructions on thermacare before she used the product.The location of the burn is to the left of her belly button on the lower part of the abdomen.The product was originally applied to the right side and there is a small area there.She confirms it is a blister and scarred but not as bad as the left.That looks like her skin is peeling off.She had been using thermacare that day for about 8 hours.She did not consult a healthcare professional for the problem(s)/symptom(s), but only went to the pharmacy at her job and spoke to a pharmacist who recommended the burn cream.The product was discarded by the patient.Upon follow-up on 07jan2020, the following was reported: lab data of 22lbs, and height of 5'8.For event blister, there was no hospitalization, treatment was received.The patient stated skin is healing, but she has scars.Action taken with thermacare heatwrap is permanently withdrawn.The outcome of the event was not recovered.According to product quality complaint group: per dchu: severity of harm was reported as s3.Conclusion: a full investigation was not performed as providing the batch record information is the manufacturing site's requirement.Therefore, a summary investigation was performed.Based on the complaint narrative, the patient developed skin redness and blisters that caused pain after product use.Review of complaint description concludes there is no device malfunction.Per site: summary of investigation: this investigation was conducted for an unknown lot number menstrual 8hr product.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 trend identified related for the subclass adverse event/serious/unknown.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/serious/unknown.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.Lot trend assmt.& rationale: a lot trend was not performed as the lot number is unknown.The sample had not been received by the site.Follow-up (19dec2019): new information received from a product quality complaint group includes severity of harm and site sample was not received.Follow-up (20dec2019): new information received from a product quality complaint group includes investigation results.Follow-up (07jan2020): new information received from a contactable consumer includes: lab data, product information (added indication), no hospitalization involved, and event information.Amendment: this follow-up report is being submitted to notify us food and drug administration (fda) that mfr report number 1066015-2019-00562 and mfr report number 1066015-2020-00022 are duplicate.All subsequent follow-up information will be reported under mfr report number 1066015-2019-00562.Mfr report number 1066015-2020-00022 is to be considered as deleted.Follow-up attempts are completed.No further information is expected., comment: based on the information provided, the event burns second degree as described is considered serious bodily injury 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.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.Product effect varies with each individual.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

9511938

MDR Text Key

188815312

Report Number

1066015-2019-00562

Device Sequence Number

Product Code

IMD

UDI-Device Identifier

00305733020069

UDI-Public

305733020069

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,Followup

Report Date

12/16/2019

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

Was Device Available for Evaluation?

Initial Date Manufacturer Received

Not provided

Initial Date FDA Received

12/23/2019

Supplement Dates Manufacturer Received

Not provided
Not provided
01/07/2020
01/07/2020

Supplement Dates FDA Received

01/07/2020
01/08/2020
02/05/2020
02/22/2021

Is This a Reprocessed and Reused Single-Use Device?

Patient Sequence Number

Patient Outcome(s)

Required Intervention;

Patient Age

33 YR

Patient Weight

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

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