MAUDE Adverse Event Report: PFIZER CONSUMER HEALTH CARE THERMACARE NECK, SHOULDER & WRIST; DISPOSABLE PACK, HOT

PFIZER CONSUMER HEALTH CARE THERMACARE NECK, SHOULDER & WRIST; DISPOSABLE PACK, HOT

Lot Number N15773 N02/24

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

Patient Problems Itching Sensation (1943); Pain (1994); Swelling (2091); Neck Stiffness (2434); Partial thickness (Second Degree) Burn (2694)

Event Date 02/01/2017

Event Type Injury

Event Description

Event verbatim [preferred term].Burn 2nd degree, burn blister with pain and itching/burn blisters on neck left, dorsal side approximately 1.5cmx2.5cm, dorsally almost centered 1cmx1cm and right side redness 2.5cmx3.5cm/burn redness [burns second degree], she controlled her skin at the beginning of application every hour and during the last days, only during putting on and off the heat wrap [intentional device misuse], she controlled her skin at the beginning of application every hour and during the last days only during putting on and off the heat wrap [device use error], burn 2nd degree, burn blister with pain and itching [pruritus], the patient assumes a production mistake [product quality issue], there are still stains after the blisters visible on the skin [skin discolouration].Case narrative:this is a spontaneous report from a (b)(4)-sponsored program (brand websites for devision consumer healthcare (b)(4)).A contactable consumer and contactable physician reported that a (b)(6)-year-old female patient of an unspecified ethnicity started to receive thermacare heatwrap (thermacare neck, shoulder & wrist), lot number: n15773 n02/24, expiration date: jan2019, from (b)(6) 2017 at 1 wrap applied directly on the skin once a day (always at the same time of the day for maximum of 8 hours) for 6 days for neck stiffness and neck pain.Medical history included was not under any medical treatment and did not suffer from following: diabetes, blood circulation disorders, cardiac diseases, problems to sense heat or pain on the skin, rheumatoid arthritis, reduced sense of touch, or neuropathy.The patient was not pregnant and was not at climacteric period.The complexion of the patient was described as medium-light.The skin was not sensitive and no skin disorders were reported.Concomitant medication included methocarbamol (ortoton fta) for stiff neck and relaxation therapy from (b)(6) 2017).The patient did not use thermacare in the past, but she used other producing warmth products without any problems.Thermacare was recommended by the physician for treatment of stiff neck.On the sixth day ((b)(6) 2017), the patient suffered from burn 2nd degree, burn blister with pain and itching.The patient used the product exactly according to the instructions of the physician and (b)(4).Additional information reported from physician: "on (b)(6) 2017 patient presented in my medical office.The following could be found: burn blisters on neck left, dorsal side approximately 1.5 cm x 2.5 cm, dorsally almost centered 1 cm x 1 cm and right side redness 2.5 cm x 3.5 cm - now almost healed.According to patient's report, the burn blisters occurred on the neck after six-day application of thermacare heat wrap.Patient treated her neck pain with heat wrap from (b)(6) 2017".The patient later reported that on (b)(6) 2017 at 16:00, during putting off the heat wrap, she discovered burning blisters.She recovered from the event after approximately 1 month ((b)(6) 2017) of itching and pain.These events did not require hospitalization and no treatment was received.She informed that during thermacare application, she did no sports.She also reported that she controlled her skin at the beginning of application every hour and during the last days ((b)(6) 2017), only during putting on and off the heat wrap.She read the instruction leaflet.She assumes a production mistake.She stated that there are still stains after the blisters visible on the skin (from 2017).She contacted a physician due to this event and received a recommendation from the physician and later from a pharmacist.The action taken in response to the events for thermacare heat wrap was permanently withdrawn on (b)(6) 2017.The outcome of burn 2nd degree, burn blister with pain and itching/burn blisters on neck left, dorsal side approximately 1.5cmx2.5cm, dorsally almost centered 1cmx1cm and right side redness 2.5cmx3.5cm/burn redness was resolved in (b)(6) 2017.The outcome of she controlled her skin at the beginning of application every hour and during the last days, only during putting on and off the heat wrap was resolved on (b)(6) 2017.The outcome of the other event was unknown.Additional information has been requested and will be provided as it becomes available.Follow-up ((b)(6) 2017): new information received from the contactable consumer includes: patient data (weight, height), information concerning medical history and past product use, suspect product data (lot number, expiration date, dosage regimen details), concomitant medication (methocarbamol), event/product complaint data (stop date, outcome, no hospitalization or treatment for previously reported events; newly reported "she controlled her skin at the beginning of application every hour and during the last days only during putting on and off the heat wrap", "there are still stains after the blisters visible on the skin", "the patient assumes a production mistake").Company clinical evaluation comment: based on the information provided, the event burn 2nd degree, intentional device misuse, and device use error as described in this case is considered a serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure, and the event is assessed as associated with the use of the device.The other events pruritus, skin discoloration, and product quality issue are assessed as associated with device use., comment: based on the information provided, the event burn 2nd degree, intentional device misuse, and device use error as described in this case is considered a serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure, and the event is assessed as associated with the use of the device.The other events pruritus, skin discoloration, and product quality issue are assessed as associated with device use.

Manufacturer Narrative

The root cause category is non-assignable (complaint not confirmed).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.Consumer alleges burn from 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.

Event Description

Event verbatim [preferred term] burn 2nd degree, burn blister with pain and itching/burn blisters on neck left, dorsal side approximately 1.5cmx2.5cm, dorsally almost centered 1cmx1cm and right side redness 2.5cmx3.5cm/burn redness [burns second degree], she controlled her skin at the beginning of application every hour and during the last days, only during putting on and off the heat wrap [intentional device misuse], she controlled her skin at the beginning of application every hour and during the last days only during putting on and off the heat wrap [wrong technique in device usage process], burn 2nd degree, burn blister with pain and itching [pruritus], the patient assumed a production mistake [product quality issue], there were still stains after the blisters visible on the skin [skin discolouration].Case narrative: this is a spontaneous report from a pfizer-sponsored program (brand websites for (b)(6)).A contactable consumer and contactable physician reported that a (b)(6) female patient of an unspecified ethnicity started to receive thermacare heatwrap (thermacare neck, shoulder & wrist), lot number: n15773 n02/24, expiration date: jan2019, from (b)(6) 2017 at 1 wrap applied directly on the skin once a day (always at the same time of the day for maximum of 8 hours) for 6 days for neck stiffness and neck pain.Medical history included was not under any medical treatment and did not suffer from following: diabetes, blood circulation disorders, cardiac diseases, problems to sense heat or pain on the skin, rheumatoid arthritis, reduced sense of touch, or neuropathy.The patient was not pregnant and was not at climacteric period.The complexion of the patient was described as medium-light.The skin was not sensitive and no skin disorders were reported.Concomitant medication included methocarbamol (ortoton fta) for stiff neck and relaxation therapy from (b)(6) 2017).The patient did not use thermacare in the past, but she used other producing warmth products without any problems.Thermacare was recommended by the physician for treatment of stiff neck.On the sixth day ((b)(6) 2017), the patient suffered from burn 2nd degree, burn blister with pain and itching.The patient used the product exactly according to the instructions of the physician and pfizer.Additional information reported from physician: "on (b)(6) 2017 patient presented in my medical office.The following could be found: burn blisters on neck left, dorsal side approximately 1.5 cm x 2.5 cm, dorsally almost centered 1 cm x 1 cm and right side redness 2.5 cm x 3.5 cm - now almost healed.According to patient's report, the burn blisters occurred on the neck after six-day application of thermacare heat wrap.Patient treated her neck pain with heat wrap from (b)(6) 2017".The patient later reported that on (b)(6) 2017 at 16:00, during putting off the heat wrap, she discovered burning blisters.She recovered from the event after approximately 1 month ((b)(6) 2017) of itching and pain.These events did not require hospitalization and no treatment was received.She informed that during thermacare application, she did no sports.She also reported that she controlled her skin at the beginning of application every hour and during the last days ((b)(6) 2017), only during putting on and off the heat wrap.She read the instruction leaflet.She assumes a production mistake.She stated that there are still stains after the blisters visible on the skin (from 2017).She contacted a physician due to this event and received a recommendation from the physician and later from a pharmacist.The action taken in response to the events for thermacare heat wrap was permanently withdrawn on (b)(6) 2017.The outcome of "burn 2nd degree, burn blister with pain and itching/burn blisters on neck left, dorsal side approximately 1.5cmx2.5cm, dorsally almost centered 1cmx1cm and right side redness 2.5cmx3.5cm/burn redness" was resolved in (b)(6) 2017.The outcome of "she controlled her skin at the beginning of application every hour and during the last days, only during putting on and off the heat wrap" was resolved on (b)(6) 2017.The outcome of the other event was unknown.According to the product quality complaint group: the root cause category is non-assignable (complaint not confirmed).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.Consumer alleges burn from 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.Additional information has been requested and will be provided as it becomes available.Follow-up (11apr2017): new information received from the contactable consumer includes: patient data (weight, height), information concerning medical history and past product use, suspect product data (lot number, expiration date, dosage regimen details), concomitant medication (methocarbamol), event/product complaint data (stop date, outcome, no hospitalization or treatment for previously reported events; newly reported "she controlled her skin at the beginning of application every hour and during the last days only during putting on and off the heat wrap", "there are still stains after the blisters visible on the skin", "the patient assumes a production mistake").Follow-up (03may2017): new information received from the product quality complaint group included investigational results.Company clinical evaluation comment: based on the information provided, the event burn 2nd degree, intentional device misuse, and device use error as described in this case is considered a serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure, and the event is assessed as associated with the use of the device.The other events pruritus, skin discoloration, and product quality issue are assessed as associated with device use.Comment: based on the information provided, the event burn 2nd degree, intentional device misuse, and device use error as described in this case is considered a serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure, and the event is assessed as associated with the use of the device.The other events pruritus, skin discoloration, and product quality issue are assessed as associated with device use.

Manufacturer Narrative

Event Description

Event verbatim [preferred term] burn 2nd degree, burn blister with pain and itching/burn blisters on neck left, dorsal side approximately 1.5cmx2.5cm, dorsally almost centered 1cmx1cm and right side redness 2.5cmx3.5cm/burn redness [burns second degree] , she controlled her skin at the beginning of application every hour and during the last days, only during putting on and off the heat wrap [intentional device misuse] , she controlled her skin at the beginning of application every hour and during the last days only during putting on and off the heat wrap [device use error] , burn 2nd degree, burn blister with pain and itching [pruritus] , the patient assumed a production mistake [product quality issue] , there were still stains after the blisters visible on the skin [skin discolouration] ,.Case narrative:this is a spontaneous report from a pfizer-sponsored program (brand websites for devision consumer healthcare (b)(4)).A contactable consumer and contactable physician reported that a (b)(6) female patient of an unspecified ethnicity started to receive thermacare heatwrap (thermacare neck, shoulder & wrist), lot number: n15773 n02/24, expiration date: jan2019, from (b)(6) 2017 at 1 wrap applied directly on the skin once a day (always at the same time of the day for maximum of 8 hours) for 6 days for neck stiffness and neck pain.Medical history included was not under any medical treatment and did not suffer from following: diabetes, blood circulation disorders, cardiac diseases, problems to sense heat or pain on the skin, rheumatoid arthritis, reduced sense of touch, or neuropathy.The patient was not pregnant and was not at climacteric period.The complexion of the patient was described as medium-light.The skin was not sensitive and no skin disorders were reported.Concomitant medication included methocarbamol (ortoton fta) for stiff neck and relaxation therapy from (b)(6) 2017 to (b)(6) 2017.The patient did not use thermacare in the past, but she used other producing warmth products without any problems.Thermacare was recommended by the physician for treatment of stiff neck.On the sixth day (b)(6) 2017), the patient suffered from burn 2nd degree, burn blister with pain and itching.The patient used the product exactly according to the instructions of the physician and pfizer.Additional information reported from physician: "on (b)(6) 2017 patient presented in my medical office.The following could be found: burn blisters on neck left, dorsal side approximately 1.5 cm x 2.5 cm, dorsally almost centered 1 cm x 1 cm and right side redness 2.5 cm x 3.5 cm - now almost healed.According to patient's report, the burn blisters occurred on the neck after six-day application of thermacare heat wrap.Patient treated her neck pain with heat wrap from (b)(6) 2017 to (b)(6) 2017".The patient later reported that on (b)(6) 2017 at 16:00, during putting off the heat wrap, she discovered burning blisters.She recovered from the event after approximately 1 month ((b)(6) 2017) of itching and pain.These events did not require hospitalization and no treatment was received.She informed that during thermacare application, she did no sports.She also reported that she controlled her skin at the beginning of application every hour and during the last days ((b)(6) 2017), only during putting on and off the heat wrap.She read the instruction leaflet.She assumed a production mistake.She stated that there were still stains after the blisters visible on the skin (from 2017).She contacted a physician due to this event and received a recommendation from the physician and later from a pharmacist.The action taken in response to the events for thermacare heat wrap was permanently withdrawn on (b)(6) 2017.The outcome of "burn 2nd degree, burn blister with pain and itching/burn blisters on neck left, dorsal side approximately 1.5cmx2.5cm, dorsally almost centered 1cmx1cm and right side redness 2.5cmx3.5cm/burn redness" was resolved in (b)(6) 2017.The outcome of "she controlled her skin at the beginning of application every hour and during the last days, only during putting on and off the heat wrap" was resolved on (b)(6) 2017.The outcome of the event there were still stains after the blisters visible on the skin was unknown.According to the product quality complaint group: the root cause category is non-assignable (complaint not confirmed).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.Consumer alleges burn from 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.Additional information has been requested and will be provided as it becomes available.Follow-up (11apr2017): new information received from the contactable consumer includes: patient data (weight, height), information concerning medical history and past product use, suspect product data (lot number, expiration date, dosage regimen details), concomitant medication (methocarbamol), event/product complaint data (stop date, outcome, no hospitalization or treatment for previously reported events; newly reported "she controlled her skin at the beginning of application every hour and during the last days only during putting on and off the heat wrap", "there are still stains after the blisters visible on the skin", "the patient assumes a production mistake").Follow-up (03may2017): new information received from the product quality complaint group included investigational results.Amendment: this follow-up report is being submitted to amend previously reported information: the event "she controlled her skin at the beginning of application every hour and during the last days only during putting on and off the heat wrap" was recoded from "wrong technique in device usage process" to "device use error".Company clinical evaluation comment based on the information provided, the event burn 2nd degree, intentional device misuse, and device use error as described in this case is considered a serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure, and the event is assessed as associated with the use of the device.The other events pruritus, skin discoloration, and product quality issue are assessed as associated with device use., comment: based on the information provided, the event burn 2nd degree, intentional device misuse, and device use error as described in this case is considered a serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure, and the event is assessed as associated with the use of the device.The other events pruritus, skin discoloration, and product quality issue are assessed as associated with device use.

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Brand Name

THERMACARE NECK, SHOULDER & WRIST

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

6375911

MDR Text Key

69014868

Report Number

1066015-2017-00047

Device Sequence Number

Product Code

IMD

Combination Product (y/n)

PMA/PMN Number

K953442

Number of Events Reported

Summary Report (Y/N)

Report Source

Manufacturer

Source Type

foreign,health professional

Reporter Occupation

Other

Type of Report

Initial,Followup,Followup,Followup

Report Date

02/23/2017

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?

Yes

Device Operator

Lay User/Patient

Device Expiration Date

01/01/2019

Device Lot Number

N15773 N02/24

Is the Reporter a Health Professional?

Initial Date Manufacturer Received

Not provided

Initial Date FDA Received

03/03/2017

Supplement Dates Manufacturer Received

Not provided
Not provided
Not provided

Supplement Dates FDA Received

04/19/2017
05/10/2017
05/19/2017

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?

Type of Device Usage

Initial

Patient Sequence Number

Patient Outcome(s)

Required Intervention;

Patient Age

25 YR

MAUDE Adverse Event Report: PFIZER CONSUMER HEALTH CARE THERMACARE NECK, SHOULDER & WRIST; DISPOSABLE PACK, HOT

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