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

Lot Number N15776

Device Problem Use of Device Problem (1670)

Patient Problems Hemorrhage/Bleeding (1888); Tissue Damage (2104); Rupture (2208); Injury (2348); Partial thickness (Second Degree) Burn (2694)

Event Type  Injury  

Event Description

Event verbatim [preferred term] a burn about 3 inches wide and about 2 inches long with 3 little blister spots [burns second degree] , did not check the skin under the heatwrap at all [intentional device misuse] , it was bleeding [wound haemorrhage] , when he took it off after 8 hours, there was like dead piece of skin attached to it [skin exfoliation] , open wound [wound] , one of the blisters had kind of broke open and the big one was bleeding [blister rupture] ,.Case narrative:this is a spontaneous report from a contactable consumer reporting on behalf of her husband.This (b)(6) male patient started to use thermacare heatwrap (thermacare heatwrap) (device lot number: n15776, expiration date: mar2019) from an unspecified date for back pain.The patient's medical history was reported as none.There were no concomitant medications.Past product history included thermacare heatwraps (thermacare heatwraps) from an unspecified date for an unspecified indication with no adverse effect.On (b)(6) 2016, the reporter stated her husband used the heatwrap and experienced a burn about 3 inches wide and about 2 inches long on his back "almost right above his booty".She described the burn as three little blister spots, probably the size of a dime around where he was burned.Her husband took off the heatwrap after 8 hours and there was like a dead piece of skin attached to it.She stated it was more like a burn, immediately she raised off his shirt and found an open wound.When she went down to wipe it, it was bleeding.The reporter stated one of the blisters had kind of broke open and the big one was bleeding.She stated her husband did not check the skin under the heatwrap at all during use.The patient tried to take a shower but he could not even wash his back because it hurt so bad.The reporter stated they did not seek medical attention so they did not know what degree of burn it was.The patient's skin tone was assessed as dark.The wrap did not have any defects like cuts, tears, leaks or holes.The patient did not use any creams, rubs or gels under the wrap during use.He did not change or modify the wrap in any way.The patient did not put the product in the microwave and did not use the heatwrap overnight or while sleeping.He used the wrap over healthy skin and over the correct part of the body.The patient did not overlap the heatwraps and did not apply any pressure over the wrap.He did not wear more than 2 layers of clothing over the heatwrap and did not sit or recline for a prolonged period of time during usage.The patient wore the wraps for 8 hours and did not use more than one heatwrap per day.Action taken with the suspect product was unknown.Therapeutic measures taken included an unspecified triple antibiotic ointment and a bandage.Clinical outcome of the 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 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 events are assessed as associated with the use of the device.This case meets initial 10-day eu and 30-day fda reportability., comment: based on the information provided, the events 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 events are assessed as associated with the use of the device.This case meets initial 10-day eu and 30-day fda reportability.

Manufacturer Narrative

Investigation summary: the root cause category is non-assignable (complaint not confirmed).Our 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.No quality issues were identified upon this review of the batch device history record, in process attributes and variable quality checks 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.Process related was no.Complaint confirmed was no.Design related was no.Notify safety was no.Capas in place was n/a.Root cause category (tier 1): non-assignable (complaint not confirmed).

Event Description

Event verbatim [preferred term] a burn about 3 inches wide and about 2 inches long with 3 little blister spots [burns second degree], did not check the skin under the heatwrap at all [device use error], it was bleeding [wound haemorrhage], when he took it off after 8 hours, there was like dead piece of skin attached to it [skin exfoliation], open wound [wound], one of the blisters had kind of broke open and the big one was bleeding [blister rupture].Case narrative: this is a spontaneous report from a contactable consumer reporting on behalf of her husband.This (b)(6) african american male patient started to use thermacare heatwrap (thermacare lower back & hip) (device lot number: n15776, expiration date: mar2019) from an unspecified date for back pain.The patient's medical history was reported as none.There were no concomitant medications.Past product history included thermacare heatwraps (thermacare heatwraps) from an unspecified date for an unspecified indication with no adverse effect.On (b)(6) 2016, the reporter stated her husband used the heatwrap and experienced a burn about 3 inches wide and about 2 inches long on his back "almost right above his booty".She described the burn as three little blister spots, probably the size of a dime around where he was burned.Her husband took off the heatwrap after 8 hours and there was like a dead piece of skin attached to it.She stated it was more like a burn, immediately she raised off his shirt and found an open wound.When she went down to wipe it, it was bleeding.The reporter stated one of the blisters had kind of broke open and the big one was bleeding.She stated her husband did not check the skin under the heatwrap at all during use.The reporter applied triple antibiotic lotion on it, but as soon as reporter put it on, it started burning, so reporter blew it really good and they have been keeping a bandage on it, the patient tried to take a shower on (b)(6) 2016 but he could not even wash his back because it hurt so bad.The reporter stated they did not seek medical attention so they did not know what degree of burn it was.The patient's skin tone was assessed as dark.The wrap did not have any defects like cuts, tears, leaks or holes.The patient did not use any creams, rubs or gels under the wrap during use.He did not change or modify the wrap in any way.The patient did not put the product in the microwave and did not use the heatwrap overnight or while sleeping.He used the wrap over healthy skin and over the correct part of the body.The patient did not overlap the heatwraps and did not apply any pressure over the wrap.He did not wear more than 2 layers of clothing over the heatwrap and did not sit or recline for a prolonged period of time during usage.The patient wore the wraps for 8 hours and did not use more than one heatwrap per day.Action taken with the suspect product was unknown.Therapeutic measures taken for the events "a burn about 3 inches wide and about 2 inches long with 3 little blister spots", "it was bleeding", "when he took it off after 8 hours, there was like dead piece of skin attached to it", "open wound", "one of the blisters had kind of broke open and the big one was bleeding" and included an unspecified triple antibiotic ointment and a bandage.Clinical outcome of the events was unknown.According to the product quality complaint group: investigation summary: the root cause category is non-assignable (complaint not confirmed).Our 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.No quality issues were identified upon this review of the batch device history record, in process attributes and variable quality checks 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.Process related was no.Complaint confirmed was no.Design related was no.Notify safety was no.Capas in place was n/a.Root cause category (tier 1): non-assignable (complaint not confirmed).Additional information has been requested and will be provided as it becomes available.Follow-up (12dec2016): new information received from product quality complaint group includes investigation results and updated the suspect product from thermacare heatwrap to thermacare lower back & hip.Company clinical evaluation comment: based on the information provided, the events 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 events are assessed as associated with the use of the device.This case meets final 10-day eu and 30-day fda reportability.Comment: based on the information provided, the events 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 events are assessed as associated with the use of the device.This case meets final 10-day eu and 30-day fda reportability.

• 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
• Manufacturer Contact: b green ; 235 e42nd street; new york, NY 10017
• MDR Report Key: 6066691
• MDR Text Key: 58767463
• Report Number: 1066015-2016-00137
• Device Sequence Number: 1
• Product Code: IMD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K953442
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/24/2016

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: 03/01/2019
• Device Lot Number: N15776
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/31/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/15/2016
• 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?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 48 YR
• Patient Weight: 125