MAUDE Adverse Event Report: PFIZER CONSUMER HEALTH CARE THERMACARE HEATWRAPS MULTI-PURPOSE MUSCLE PAIN; DISPOSABLE PACK, HOT

Lot Number L05913S

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Congestive Heart Failure (1783); Erythema (1840); Fall (1848); Pain (1994); Rash (2033); Thyroid Problems (2102); Transient Ischemic Attack (2109); Depression (2361)

Event Date 07/01/2015

Event Type  Injury  

Manufacturer Narrative

Company clinical evaluation comment: based on the information provided, the events blister, as described in this case is considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure, assessed as associated with the use of the device.The other events generalized rash and device misuse are assessed as associated with the device use.This case meets initial 10-day eu and 30-day fda reportability.

Event Description

Blisters [blister] forgot it was on, and went to bed, and it was on all night.She put it on at 5pm, and took it off at 8am the next morning [device misuse] rash is on her back, chest arms, and just a little bit on her face./big red spots that run in patches up her leg in front and back, on her knee, and very bright on her feet [rash generalised].Case description: this is a spontaneous report from a contactable consumer.A (b)(6) caucasian female patient started to receive thermacare heatwrap (thermacare heatwraps multi-purpose muscle pain), device lot number l05913s, expiration date nov2017, via an unspecified route of administration from (b)(6) 2015 to an unspecified date at an unknown frequency for hump in her back near her neck about down to her shoulder blades.Medical history congestive heart failure, 3 heart attacks, gerd, depression, thyroid, very weak bones, knee replacement, pacemaker, defibrillator, fall, poor circulation, heart disease, rheumatoid arthritis, allergic to beta wash in the hospital and latex.Concomitant medication included trazodone 50mg 3 times a day tablet by mouth started (b)(6) 2015, probably for heart, started (b)(6) 2015, furosemide 40mg one tab daily, amantadine 50mg pill twice a day, atorvastatin 40mg once a day tablet, nitroglycerin 1 tablet as needed, salbutamol (albuterol) aerosol once a day, budesonide flexhaler 2 puffs a day, metoprolol tartrate 50mg twice a day, started taking the beginning of this year, levothyroxine 100mg daily, tablet, for thyroid, started 10 years ago, amitriptyline 50mg 2 tablets at bedtime, for depression and sleep, started 15 years ago, and omeprazole, daily for gerd, started 10 years ago.The patient previously took levothyroxine for thyroid and reported it was not working at "88".It was reported two weeks ago ((b)(6) 2013), she put a patch on her lower neck and upper back, the muscle pain therapy kind, and forgot it was on, and went to bed, and it was on all night.She put it on at 5 pm, and took it off at 8am the next morning.Late the next day, she broke out in a really weird rash, beet red, and she can't get rid of it.There were little blisters and right next to them are little blisters and big blisters, big red spots that run in patches up her leg in the front and back, on her knee, and very bright on her feet.They feel a little rough.Rash is on her back, chest, arms, and just a little bit on her face.Only one blister in the area where the patch was and the redness looks like it is fading in that area.She stated she can't get rid of the rash.It fades a little bit and then it gets dark again; she just can't shake it.No treatment was received for the events.The action taken with thermacare heatwrap was unknown.The outcome of the events was not resolved.The patient reported her skin to be fair and sensitive.The patient previously used thermacare heatwraps on her lower back only for 45 minutes to an hour.The patient previously used electric heating pad, hot water bottle, and microwave gel pack and the patient did not experience any problems with these products.The patient reported sleeping while using the product, she applied pressure over the area, she slept on her back and the adhesive was attached to her body.The patient did not engage in exercise while wearing the product, she did not check her skin under the product while wearing, she did read the instructions before using.Additional information has been requested and will be provided as it becomes available.

Event Description

Event verbatim [preferred term] blisters [blister] , forgot it was on, and went to bed, and it was on all night.She put it on at 5 pm, and took it off at 8am the next morning [intentional device misuse] , rash is on her back, chest, arms, and just a little bit on her face./ big red spots that run in patches up her leg in the front and back, on her knee, and very bright on her feet [rash] ,.Case narrative:this is a spontaneous report from a contactable consumer.A 73-years-old caucasian female patient started to receive thermacare heatwrap (thermacare heatwraps multi-purpose muscle pain), device lot number l05913s, expiration date nov2017, via an unspecified route of administration from jul2015 to an unspecified date at an unknown frequency for hump in her back near her neck about down to her shoulder blades.Medical history congestive heart failure, 3 heart attacks, gerd, depression, thyroid, very weak bones, knee replacement, pacemaker, defibrillator, fall, poor circulation, heart disease, rheumatoid arthritis, allergic to beta wash in the hospital and latex.Concomitant medication included trazodone 50mg 3 times a day tablet by mouth started 01jun2015, probably for heart, started 6/1/15, furosemide 40mg one tab daily, amantadine 50mg pill twice a day, atorvastatin 40mg once a day tablet, nitroglycerin 1 tablet as needed, salbutamol (albuterol) aerosol once a day, budesonide flexhaler 2 puffs a day, metoprolol tartrate 50mg twice a day, started taking the beginning of this year, levothyroxine 100mg daily, tablet, for thyroid, started 10 years ago, amitriptyline 50mg 2 tablets at bedtime, for depression and sleep, started 15 years ago, and omeprazole, daily for gerd, started 10 years ago.The patient previously took levothyroxine for thyroid and reported it was not working at "88".It was reported two weeks ago (jul2015), she put a patch on her lower neck and upper back, the muscle pain therapy kind, and forgot it was on, and went to bed, and it was on all night.She put it on at 5 pm, and took it off at 8am the next morning.Late the next day, she broke out in a really weird rash, beet red, and she can't get rid of it.There were little blisters and right next to them are little blisters and big blisters, big red spots that run in patches up her leg in the front and back, on her knee, and very bright on her feet.They feel a little rough.Rash is on her back, chest, arms, and just a little bit on her face.Only one blister in the area where the patch was and the redness looks like it is fading in that area.She stated she can't get rid of the rash.It fades a little bit and then it gets dark again; she just can't shake it.No treatment was received for the events.The action taken with themacare heatwrap was unknown.The outcome of the events was not resolved.The patient reported her skin to be fair and sensitive.The patient previously used thermacare heatwraps on her lower back only for 45 minutes to an hour.The patient previously used electric heating pad, hot water bottle, and microwave gel pack and the patient did not experience any problems with these products.The patient reported sleeping while using the product, she applied pressure over the area, she slept on her back and the adhesive was attached to her body.The patient did not engage in exercise while wearing the product, she did not check her skin under the product while wearing, she did read the instructions before using.Additional information has been requested and will be provided as it becomes available.Company clinical evaluation comment: based on the information provided, the events blister, as described in this case is considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure, assessed as associated with the use of the device.The other events generalized rash and device misuse are assessed as associated with the device use.This case meets initial 10-day eu and 30-day fda reportability.Follow-up (20nov2015): follow-up attempts are completed.No further information is expected.Follow-up (07apr2020): new information reported from product quality complaints includes investigation is still ongoing.Based on initial narrative, device age added and onset date of events added.Follow-up attempts are completed.No further information is expected., comment: based on the information provided, the events blister, as described in this case is considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure, assessed as associated with the use of the device.The other events generalized rash and device misuse are assessed as associated with the device use.This case meets initial 10-day eu and 30-day fda reportability.

• Brand Name: THERMACARE HEATWRAPS MULTI-PURPOSE MUSCLE PAIN
• Type of Device: DISPOSABLE PACK, HOT
• Manufacturer (Section D): PFIZER CONSUMER HEALTH CARE; 1231 wyandotte drive; albany GA 31705
• MDR Report Key: 4977084
• MDR Text Key: 22424157
• Report Number: 1066015-2015-00093
• Device Sequence Number: 1
• Product Code: IMD
• Combination Product (y/n): N
• PMA/PMN Number: K953442
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Followup
• Report Date: 07/22/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/01/2017
• Device Lot Number: L05913S
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/05/2015
• Supplement Dates Manufacturer Received: 07/22/2015
• Supplement Dates FDA Received: 04/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ALBUTEROL (SALBUTAMOL); ALBUTEROL /00139501/; AMANTADINE; AMANTADINE ; AMITRIPTYLINE; AMITRIPTYLINE; AMITRIPTYLINE TABLET; ATORVASTATIN; ATORVASTATIN TABLET; BUDESONIDE; BUDESONIDE ; FUROSEMIDE; FUROSEMIDE (FUROSEMIDE) TABLET; LEVOTHYROXINE SODIUM; METOPROLOL TARTRATE; METOPROLOL TARTRATE (METOPROLOL TARTRATE); NITROGLYCERIN; NITROGLYCERIN (GLYCERYL TRINITRATE) TABLET; OMEPRAZOLE; OMEPRAZOLE; TRAZODONE; TRAZODONE (TRAZODONE) TABLET
• Patient Outcome(s): Required Intervention
• Patient Age: 73 YR
• Patient Weight: 44