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

Lot Number J01199

Device Problem Use of Device Problem (1670)

Patient Problems Burning Sensation (2146); Tingling (2171); Partial thickness (Second Degree) Burn (2694)

Event Date 12/19/2015

Event Type  Injury  

Event Description

Burn blister, unpleasant tingling sensation and burning [burns second degree].10 days later the blisters were opened and the open wounds started to heal [wound].Case description: this is a spontaneous report from a pfizer sponsored program brand websites for devision consumer healthcare (b)(4).A contactable consumer reported for her husband.A male patient of an unspecified age and ethnicity started to receive thermacare heatwrap (thermacare heatwrap), in (b)(6) 2015 for muscular pain and muscular tension parietal at the ribcage.The patient medical history was not reported.The patient's concomitant medications were not reported.After the heatwrap had been applied for 4 hours in (b)(6) 2015, he had noticed an unpleasant tingling sensation and burning at the application site.The wrap was removed, two burn blisters plus one burned part of uncertain size were discovered.They treated the skin with anitseptical ointment.10 days later the blisters were opened and the open wounds started to heal.The reporter complained that in the package leaflet there is no indication that thermacare heatwrap can cause burns or allergic reactions.The action taken of the product was permanently withdrawn in (b)(6) 2015.The outcome of the events was recovering.Additional information has been requested and will be provided as it becomes available.Company clinical evaluation comment based on the information provided, the event "burn blister and open wound" as described in this case are considered serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure, and the events are assessed as associated with the use of the device.This case meets initial 10-day eu and 30-day fda reportability.Case comment: based on the information provided, the event "burn blister and open wound" as described in this case are considered serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure, and the events are assessed as associated with the use of the device.This case meets initial 10-day eu and 30-day fda reportability.

Event Description

A thick, fluid-filled burn blister, 3-4 cm in size, unpleasant burning and tingling sensation [burns second degree].Applied heatwrap directly on the body, skin was not controlled during wearing of the wrap [intentional device misuse].10 days later the blisters were opened and the open wounds started to heal [wound].Case description: this is a spontaneous report from a pfizer sponsored program brand websites for division consumer healthcare (b)(4).A contactable consumer reported for her husband.This (b)(6)-year-old male patient of an unspecified ethnicity started to use thermacare heatwrap (thermacare lower back & hip) (lot #: j01199, expiration date: sep2017) from (b)(6) 2015 for muscular pain and muscular tension parietal at the ribcage.The patient's medical history included ongoing diabetes and ongoing heart disease.Concomitant medications were reported as none.Past product history included thermacare heatwraps (thermacare heatwraps) from an unspecified date in (b)(6) 2015 over 3 days for an unspecified indication with no adverse effect.After the heatwrap had been applied directly on the body for 4 hours on the afternoon of (b)(6) 2015, the patient noticed an unpleasant burning and tingling sensation at the application site.When the wrap was removed, the patient reported a thick, fluid-filled burn blister, 3-4 cm in size.At 10 days later the blisters were opened and the open wounds started to heal.A physician/pharmacist was consulted due to the events.The reporter complained that in the package leaflet there was no indication that thermacare heatwrap could cause burns or allergic reactions.The reporter assessed her husband's skin tone as middle light.He did not have sensitive skin or any skin diseases.No sports were performed while the patient was wearing the heatwrap.The patient read the package insert prior to usage of the heatwrap.He mentioned the skin was not controlled during wearing of the wrap.No other products were used during wearing.No other warmth producing products for pain relief were administered.Action taken with the suspect product was permanently withdrawn on (b)(6) 2015.Therapeutic measures taken included mirfulan spray n and bepanthen antisept.Clinical outcome of the events was resolved on an unspecified date.Additional information has been requested and will be provided as it becomes available.Follow-up (11feb2016): new information received from the same contactable consumer includes: patient data, medical history, past product history, updated suspect product, suspect product lot number and expiration date, suspect product start/stop dates, reaction data (additional event of device misuse), additional therapeutic measures taken, event onset date and event outcome.Company clinical evaluation comment: based on the information provided, the event "burn blister and open wound" and device misuse as described in this case are considered serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure, and the events are assessed as associated with the use of the device.This case meets follow up 10-day (b)(4) and 30-day fda.Reportability.Case comment: based on the information provided, the event "burn blister and open wound" and device misuse as described in this case are considered serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure, and the events are assessed as associated with the use of the device.This case meets follow up 10-day (b)(4) and 30-day fda reportability.

Manufacturer Narrative

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.Care should be taken to use the device as it was designed, following all safety and use information as provided with the wrap to avoid the risks of burns or other skin irritations.The product effect may vary with each individual.".

Event Description

Case description: this is a spontaneous report from a pfizer sponsored program brand websites for devision consumer healthcare (b)(4).A contactable consumer reported for her husband.This (b)(6) male patient of an unspecified ethnicity started to use thermacare heatwrap (thermacare lower back & hip) (lot #: j01199, expiration date: sep2017) from (b)(6) 2015 for muscular pain and muscular tension parietal at the ribcage.The patient's medical history included ongoing diabetes and ongoing heart disease.Concomitant medications were reported as none.Past product history included thermacare heatwraps (thermacare heatwraps) from an unspecified date in (b)(6) 2015 over 3 days for an unspecified indication with no adverse effect.After the heatwrap had been applied directly on the body for 4 hours on the afternoon of (b)(6) 2015, the patient noticed an unpleasant burning and tingling sensation at the application site.When the wrap was removed, the patient reported a thick, fluid-filled burn blister, 3-4 cm in size.Ten (10) days later the blisters were opened and the open wounds started to heal.A physician/pharmacist was consulted due to the events.The reporter complained that in the package leaflet there was no indication that thermacare heatwrap could cause burns or allergic reactions.The reporter assessed her husband's skin tone as middle light.He did not have sensitive skin or any skin diseases.No sports were performed while the patient was wearing the heatwrap.The patient read the package insert prior to usage of the heatwrap.He mentioned the skin was not controlled during wearing of the wrap.No other products were used during wearing.No other warmth producing products for pain relief were administered.Action taken with the suspect product was permanently withdrawn on (b)(6) 2015.Therapeutic measures taken included mirfulan spray n and bepanthen antisept.Clinical outcome of the events was resolved on an unspecified date.New information received from product quality complaint (pqc) group includes investigation results.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.Care should be taken to use the device as it was designed, following all safety and use information as provided with the wrap to avoid the risks of burns or other skin irritations.The product effect may vary with each individual.Additional information has been requested and will be provided as it becomes available.Follow-up (11feb2016): new information received from the same contactable consumer includes: patient data, medical history, past product history, updated suspect product, suspect product lot number and expiration date, suspect product start/stop dates, reaction data (additional event of device misuse), additional therapeutic measures taken, event onset date and event outcome.Follow-up (29feb2016): new information received from product quality complaints (pqc) group included: product quality investigation results.Company clinical evaluation comment based on the information provided, the event "burn blister and open wound" and device misuse as described in this case are considered serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure, and the events are assessed as associated with the use of the device.This case meets final 10-day eu and 30-day fda reportability.Case comment: based on the information provided, the event "burn blister and open wound" and device misuse as described in this case are considered serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure, and the events are assessed as associated with the use of the device.This case meets final 10-day eu and 30-day fda reportability.Continued: evaluation summary: 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.Care should be taken to use the device as it was designed, following all safety and use information as provided with the wrap to avoid the risks of burns or other skin irritations.The product effect may vary with each individual.

Event Description

Case description: this is a spontaneous report from a pfizer sponsored program brand websites for division consumer healthcare (b)(4).A contactable consumer reported for her husband.This (b)(6)-year-old male patient of an unspecified ethnicity started to use thermacare heatwrap (thermacare lower back & hip) (lot #: j01199, expiration date: sep2017) from (b)(6) 2015 for muscular pain and muscular tension parietal at the ribcage.The patient's medical history included ongoing diabetes and ongoing heart disease.Concomitant medications were reported as none.Past product history included thermacare heatwraps (thermacare heatwraps) from an unspecified date in (b)(6) 2015 over 3 days for an unspecified indication with no adverse effect.After the heatwrap had been applied directly on the body for 4 hours on the afternoon of (b)(6) 2015, the patient noticed an unpleasant burning and tingling sensation at the application site.When the wrap was removed, the patient reported a thick, fluid-filled burn blister, 3-4 cm in size.Ten days later the blisters were opened and the open wounds started to heal.A physician/pharmacist was consulted due to the events.The reporter complained that in the package leaflet there was no indication that thermacare heatwrap could cause burns or allergic reactions.The reporter assessed her husband's skin tone as middle light.He did not have sensitive skin or any skin diseases.No sports were performed while the patient was wearing the heatwrap.The patient read the package insert prior to usage of the heatwrap.He mentioned the skin was not controlled during wearing of the wrap.No other products were used during wearing.No other warmth producing products for pain relief were administered.Action taken with the suspect product was permanently withdrawn on (b)(6) 2015.Therapeutic measures taken included mirfulan spray n and bepanthen antisept.Clinical outcome of the events was resolved on an unspecified date.New information received from product quality complaint (pqc) group includes investigation results.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.Care should be taken to use the device as it was designed, following all safety and use information as provided with the wrap to avoid the risks of burns or other skin irritations.The product effect may vary with each individual.Additional information has been requested and will be provided as it becomes available.Follow-up (11feb2016): new information received from the same contactable consumer includes: patient data, medical history, past product history, updated suspect product, suspect product lot number and expiration date, suspect product start/stop dates, reaction data (additional event of device misuse), additional therapeutic measures taken, event onset date and event outcome.Follow-up (29feb2016): new information received from product quality complaints (pqc) group included: product quality investigation results.Follow-up (08apr2016): follow-up attempts completed.No further information expected.Case closed.Follow-up (24may2016): this follow-up report is being submitted to amend previously reported information: lot number updated from jo1199 to the correct lot number j01199.Company clinical evaluation comment based on the information provided, the event "burn blister and open wound" and device misuse as described in this case are considered serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure, and the events are assessed as associated with the use of the device.This case meets final (b)(6) and 30-day fda reportability.

• Brand Name: THERMACARE LOWER BACK & HIP
• Type of Device: DISPOSABLE PACK, HOT
• Manufacturer (Section D): PFIZER CONSUMER HEALTH CARE; albany GA
• Manufacturer (Section G): PFIZER CONSUMER HEALTH CARE; 1231 wyandotte drive; albany GA 31705
• Manufacturer Contact: b green ; 235 e42nd street; new york, NY 10017 ; 2127334552
• MDR Report Key: 5383649
• MDR Text Key: 36555273
• Report Number: 1066015-2015-00165
• Device Sequence Number: 1
• Product Code: IMD
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K953442
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 12/25/2015

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: 09/01/2017
• Device Lot Number: J01199
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/25/2015
• Initial Date FDA Received: 01/21/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 02/22/2016; 03/04/2016; 05/31/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 69 YR
• Patient Weight: 102