MAUDE Adverse Event Report: PFIZER CONSUMER HEALTH CARE THERMACARE LOWER BACK & HIP; DISPOSABLE PACK, HOT

PFIZER CONSUMER HEALTH CARE THERMACARE LOWER BACK & HIP; DISPOSABLE PACK, HOT

Lot Number 3106UO18

Device Problems Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017); Expiration Date Error (2528)

Patient Problems Itching Sensation (1943); Swelling (2091); Depression (2361); Partial thickness (Second Degree) Burn (2694)

Event Date 11/11/2018

Event Type Injury

Event Description

Wrap burned the dickens out of husband's back/the blisters are regularly spaced around his back/reached to scratch an itch and scratched a blister [burns second degree], used expired product, expiry date of thermacare lower back & hip: jun 2006 [expired device used], sleeping while wearing the product/did not check skin under the product while wearing thermacare [intentional device misuse].Case narrative: this is a spontaneous report from a contactable consumer reported for her husband.A (b)(6) male patient started to receive thermacare heatwrap (thermacare lower back & hip) lot number: 3106uo18, expiration date jun2006, via an unspecified route of administration from (b)(6) 2018 to (b)(6) 2018 at unknown dose for pain/ back pain.Medical history included ongoing diabetes, depression and neuropathy in feet.Concomitant medication included ongoing ibuprofen (advil) at 200 mg, as needed (2 caplets, no.Of daily doses: 1-2) for pain.The patient threw his back out on saturday.Last night he realized they had the wraps and used one.It burned the dickens out of his back.The patient put the wrap on around 8:00pm.He woke at 1:30 because something was bothering him.He reached to scratch an itch and scratched a blister.The package indicated you could wear the wraps for up to 8 hours.The blisters were regularly spaced around his back.Reporter stated the lot was hard to read because the letters are reversed and small.She added that they should not use pale print on a red background.That the wraps were large/xl, ultra thin.While reading product details, reporter read expiration date as jun2006.She stated apparently the product was purchased and never used.The patient was less likely to use it again.The patient did not have wussy skin.He could go outside and tans easily.The patient had not contacted his doctor and nothing had been applied to the blisters.Reporter commented on the print from the box.She added that typically those who use products were elderly and had problems with their vision.The skin tone was classified as dark or olive.He did not have sensitive skin.He did not have any abnormal skin conditions.He purchased red box.Only the used wrap was remaining.He used thermacare 1 day in a row and 5 hours per day (from 8:00pm until 1:30am).The patient applied wrap at 8:00pm.He woke at 1:30am because something was bothering him.He reached to scratch an itch and scratched a blister.He had not previously used thermacare.He had previously used other heat products for pain relief, not with this occurrence.He had not previously experienced a problem/symptom with one of these products.He was sleeping while wearing the product.He attached the adhesive to body.He did not engage in exercise while using the product.He did not check skin under the product while wearing thermacare.He read the usage instructions on thermacare before used the product.He did not consult a healthcare professional for the problem.The action taken in response to the events of the product was permanently discontinued.The outcome of wrap burned the dickens out of husbands back/the blisters are regularly spaced around his back/ reached to scratch an itch and scratched a blister was not resolved.The outcome of other events was 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 blisters", "expired device used" and "intentional device misuse" as described are considered serious bodily injury potentially 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: complaint can not be confirmed, product expired in 2006.Process related: no.Complaint confirmed: no.Design related: no.Notify safety: no.Conclusion & approvals: additional approval(s) req'd: no.Root cause category (tier 1): non-assignable (complaint not confirmed).Regulatory impact: no.Other regulatory notification: n/a.Product quality impact: no.Stability impact: no.Market / clinical impact: no.Sqrt review required: no.Final confirmation status: not confirmed.Aqrt review req'd: no.

Event Description

Wrap burned the dickens out of husbands back/the blisters are regularly spaced around his back/reached to scratch an itch and scratched a blister [burns second degree] , used expired product, expiry date of thermacare lower back & hip: jun 2006 [expired device used], sleeping while wearing the product/did not check skin under the product while wearing thermacare [intentional device misuse].Case narrative:this is a spontaneous report from a contactable consumer reported for her husband.A 59-year-old male patient started to receive thermacare heatwrap (thermacare lower back & hip) lot number: 3106uo18, expiration date jun2006, via an unspecified route of administration from on (b)(6) 2018 at unknown dose for pain/ back pain.Medical history included ongoing diabetes, depression and neuropathy in feet.Concomitant medication included ongoing ibuprofen (advil) at 200 mg, as needed (2 caplets, no.Of daily doses: 1-2) for pain.The patient threw his back out on saturday.Last night he realized they had the wraps and used one.It burned the dickens out of his back.The patient put the wrap on around 8:00pm.He woke at 1:30 because something was bothering him.He reached to scratch an itch and scratched a blister.The package indicated you could wear the wraps for up to 8 hours.The blisters were regularly spaced around his back.Reporter stated the lot was hard to read because the letters are reversed and small.She added that they should not use pale print on a red background.That the wraps were large/xl, ultra thin.While reading product details, reporter read expiration date as jun2006.She stated apparently the product was purchased and never used.The patient was less likely to use it again.The patient did not have wussy skin.He could go outside and tans easily.The patient had not contacted his doctor and nothing had been applied to the blisters.Reporter commented on the print from the box.She added that typically those who use products were elderly and had problems with their vision.The skin tone was classified as dark or olive.He did not have sensitive skin.He did not have any abnormal skin conditions.He purchased red box.Only the used wrap was remaining.He used thermacare 1 day in a row and 5 hours per day (from 8:00pm until 1:30am).The patient applied wrap at 8:00pm.He woke at 1:30am because something was bothering him.He reached to scratch an itch and scratched a blister.He had not previously used thermacare.He had previously used other heat products for pain relief, not with this occurrence.He had not previously experienced a problem/symptom with one of these products.He was sleeping while wearing the product.He attached the adhesive to body.He did not engage in exercise while using the product.He did not check skin under the product while wearing thermacare.He read the usage instructions on thermacare before used the product.He did not consult a healthcare professional for the problem.The action taken in response to the events of the product was permanently discontinued.The outcome of wrap burned the dickens out of husbands back/the blisters are regularly spaced around his back/ reached to scratch an itch and scratched a blister was not resolved.The outcome of other events was unknown.According to product quality complaints, investigation summary: complaint can not be confirmed, product expired in 2006.Process related: no.Complaint confirmed: no.Design related: no.Notify safety: no.Conclusion & approvals: additional approval(s) req'd: no.Root cause category (tier 1): non-assignable (complaint not confirmed).Regulatory impact: no.Other regulatory notification: n/a.Product quality impact: no.Stability impact: no.Market / clinical impact: no.Sqrt review required: no.Final confirmation status: not confirmed.Aqrt review req'd: no.Follow-up (21dec2018): new information received from product quality complaints included: investigation results.Company clinical evaluation comment: based on the information provided, the events of "burn blisters", "expired device used" and "intentional device misuse" as described are considered serious bodily injury potentially 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 "burn blisters", "expired device used" and "intentional device misuse" as described are considered serious bodily injury potentially 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] wrap burned the dickens out of husbands back/the blisters are regularly spaced around his back/reached to scratch an itch and scratched a blister [burns second degree] , used expired product, expiry date of thermacare lower back & hip: jun 2006 [expired device used] , sleeping while wearing the product/did not check skin under the product while wearing thermacare [intentional device misuse] ,.Case narrative:this is a spontaneous report from a contactable consumer reported for her husband.A 59-year-old male patient started to receive thermacare heatwrap (thermacare lower back & hip) lot number: 3106uo18, expiration date jun2006, via an unspecified route of administration from (b)(6) 2018 to (b)(6) 2018 at unknown dose for pain/ back pain.Medical history included ongoing diabetes, depression and neuropathy in feet.Concomitant medication included ongoing ibuprofen (advil) at 200 mg, as needed (2 caplets, no.Of daily doses: 1-2) for pain.The patient threw his back out on saturday.Last night he realized they had the wraps and used one.It burned the dickens out of his back.The patient put the wrap on around 8:00pm.He woke at 1:30 because something was bothering him.He reached to scratch an itch and scratched a blister.The package indicated you could wear the wraps for up to 8 hours.The blisters were regularly spaced around his back.Reporter stated the lot was hard to read because the letters are reversed and small.She added that they should not use pale print on a red background.That the wraps were large/xl, ultra thin.While reading product details, reporter read expiration date as jun2006.She stated apparently the product was purchased and never used.The patient was less likely to use it again.The patient did not have wussy skin.He could go outside and tans easily.The patient had not contacted his doctor and nothing had been applied to the blisters.Reporter commented on the print from the box.She added that typically those who use products were elderly and had problems with their vision.The skin tone was classified as dark or olive.He did not have sensitive skin.He did not have any abnormal skin conditions.He purchased red box.Only the used wrap was remaining.He used thermacare 1 day in a row and 5 hours per day (from 8:00pm until 1:30am).The patient applied wrap at 8:00pm.He woke at 1:30am because something was bothering him.He reached to scratch an itch and scratched a blister.He had not previously used thermacare.He had previously used other heat products for pain relief, not with this occurrence.He had not previously experienced a problem/symptom with one of these products.He was sleeping while wearing the product.He attached the adhesive to body.He did not engage in exercise while using the product.He did not check skin under the product while wearing thermacare.He read the usage instructions on thermacare before used the product.He did not consult a healthcare professional for the problem.The action taken in response to the events of the product was permanently discontinued on 12nov2018.The outcome of wrap burned the dickens out of husbands back/the blisters are regularly spaced around his back/ reached to scratch an itch and scratched a blister was not resolved.The outcome of other events was unknown.Upon follow up on 18mar2019, the patient did not provide information to the physician regarding the reported adverse events with the use of the product.According to product quality complaints, investigation summary: complaint can not be confirmed, product expired in 2006.Process related: no.Complaint confirmed: no.Design related: no.Notify safety: no.Conclusion & approvals: additional approval(s) req'd: no.Root cause category (tier 1): non-assignable (complaint not confirmed).Regulatory impact: no.Other regulatory notification: n/a.Product quality impact: no.Stability impact: no.Market / clinical impact: no.Sqrt review required: no.Final confirmation status: not confirmed.Aqrt review req'd: no.Follow-up (21dec2018): new information received from product quality complaints included: investigation results.Follow-up (18mar2019): new information received from a contactable physician including: the patient did not provide information to the physician regarding the reported adverse events with the use of the product.Company clinical evaluation comment: based on the information provided, the events of "burn blisters", "expired device used" and "intentional device misuse" as described are considered serious bodily injury potentially 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 "burn blisters", "expired device used" and "intentional device misuse" as described are considered serious bodily injury potentially 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.

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Brand Name

THERMACARE LOWER BACK & HIP

Type of Device

DISPOSABLE PACK, HOT

Manufacturer (Section D)

PFIZER CONSUMER HEALTH CARE

1231 wyandotte drive

albany GA 31705

MDR Report Key

8094523

MDR Text Key

128050829

Report Number

1066015-2018-00161

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

consumer,health professional

Type of Report

Initial,Followup,Followup

Report Date

11/12/2018

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

06/01/2006

Device Lot Number

3106UO18

Initial Date Manufacturer Received

Not provided

Initial Date FDA Received

11/21/2018

Supplement Dates Manufacturer Received

Not provided
Not provided

Supplement Dates FDA Received

01/02/2019
03/26/2019

Is This a Reprocessed and Reused Single-Use Device?

Patient Sequence Number

Treatment

ADVIL [IBUPROFEN]; ADVIL [IBUPROFEN]; ADVIL [IBUPROFEN]; ADVIL [IBUPROFEN]

Patient Outcome(s)

Required Intervention;

Patient Age

59 YR

Patient Weight

MAUDE Adverse Event Report: PFIZER CONSUMER HEALTH CARE THERMACARE LOWER BACK & HIP; DISPOSABLE PACK, HOT

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