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

Lot Number N15776

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Erythema (1840); Swelling (2091); Burning Sensation (2146); Fluid Discharge (2686); Partial thickness (Second Degree) Burn (2694)

Event Type  Injury  

Event Description

Burning sensation, burns, had three popped blister wounds where the patch had been [burns second degree] , three popped blister wounds where the patch had been [blister rupture] , they are angry red and oozing even two days later [wound drainage] , applied heatwrap as directed to help ease pain caused by cramps [intentional device misuse] ,.Case narrative:this is a spontaneous report from a pfizer-sponsored program, thermacare (b)(6) page.A contactable consumer reported a patient of unspecified age, ethnicity and gender started to use thermacare heatwrap (thermacare lower back & hip) (device lot number: n15776, expiration date: mar2019) from an unspecified date to help ease pain caused by cramps.The patient's medical history and concomitant medications were not reported.Past product history included thermacare heatwraps (thermacare heatwraps) from an unspecified date for an unspecified indication with no adverse effect.On an unspecified date, the patient reported they applied the patch as directed and wore the heatwrap for about 6 hours.The patient stated as they were removing the patch before bed, they felt a burning sensation.The patient looked and noticed three popped blister wounds where the patch had been.The patient stated "if i had been tending to these burns, and cleaning them, but they are angry red and oozing even two days later.I intend to see a doctor as soon as possible.I'm unsure as to why this particular one burned and blistered me so badly." action taken with the suspect product was unknown.Clinical outcome of the events was unknown.No follow-up attempts are possible.No further information is expected.Company clinical evaluation comment based on the information provided, the events burn second degree, blister rupture, wound drainage, and intentional device misuse as described in this case are considered serious bodily injuries potentially requiring medical intervention to prevent permanent damage or impairment of body structure, assessed as associated with the use of the device., comment: based on the information provided, the events burn second degree, blister rupture, wound drainage, and intentional device misuse as described in this case are considered serious bodily injuries potentially requiring medical intervention to prevent permanent damage or impairment of body structure, assessed as associated with the use of the device.

Manufacturer Narrative

The root cause category is non assignable (complaint not confirmed).The plant has reviewed this batch from a manufacturing and technical 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.The cause of the 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.

Event Description

Event verbatim [preferred term] burning sensation, burns, had three popped blister wounds where the patch had been [burns second degree], three popped blister wounds where the patch had been [blister rupture] , they are angry red and oozing even two days later [wound drainage], applied heatwrap as directed to help ease pain caused by cramps [device use issue].Case narrative: this is a spontaneous report from a pfizer-sponsored program, thermacare (b)(6) page.A contactable consumer reported a patient of unspecified age, ethnicity and gender started to use thermacare heatwrap (thermacare lower back & hip) (device lot number: n15776, expiration date: mar2019) from an unspecified date to help ease pain caused by cramps.The patient's medical history and concomitant medications were not reported.Past product history included thermacare heatwraps (thermacare heatwraps) from an unspecified date for an unspecified indication with no adverse effect.On an unspecified date, the patient reported they applied the patch as directed and wore the heatwrap for about 6 hours.The patient stated as they were removing the patch before bed, they felt a burning sensation.The patient looked and noticed three popped blister wounds where the patch had been.The patient stated "if i had been tending to these burns, and cleaning them, but they are angry red and oozing even two days later.I intend to see a doctor as soon as possible.I'm unsure as to why this particular one burned and blistered me so badly." action taken with the suspect product was unknown.Clinical outcome of the events was unknown.Additional information received from product quality complaint (pqc) group included investigation results.The root cause category is non assignable (complaint not confirmed).The plant has reviewed this batch from a manufacturing and technical 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.The cause of the 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.Follow up (20feb2017): new information received from product quality complaints (pqc) group included: product quality investigation results.No follow-up attempts are possible.No further information is expected.Company clinical evaluation comment: based on the information provided, the events burn second degree, blister rupture, wound drainage, and intentional device misuse as described in this case are considered serious bodily injuries potentially requiring medical intervention to prevent permanent damage or impairment of body structure, assessed as associated with the use of the device.No device malfunction has been identified.Comment: based on the information provided, the events burn second degree, blister rupture, wound drainage, and intentional device misuse as described in this case are considered serious bodily injuries potentially requiring medical intervention to prevent permanent damage or impairment of body structure, assessed as associated with the use of the device.No device malfunction has been identified.

• 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: 6218082
• MDR Text Key: 63720535
• Report Number: 1066015-2016-00169
• 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: 12/26/2016

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: 01/03/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/22/2017
• 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?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention