MAUDE Adverse Event Report: PFIZER CONSUMER HEALTH CARE THERMACARE NECK, SHOULDER & WRIST; DISPOSABLE PACK, HOT

Device Problem Temperature Problem (3022)

Patient Problems Erythema (1840); Scarring (2061); Partial thickness (Second Degree) Burn (2694)

Event Date 11/14/2016

Event Type  Injury  

Event Description

Event verbatim [preferred term] area looked like she had been burnt by a hot object (like a hot iron burn)/ 10mm blister in the center at the base of the neck and a +-3mm blister on the right side of the base of the neck [burns second degree] , scarring [scar] , surrounding erythema [erythema] , using thermacare heatwrap and had a history of poor circulation [device use error] ,.Case narrative:this is a spontaneous report from a contactable pharmacist received via a sales representative.A (b)(6) female patient started to use thermacare heatwrap (thermacare neck, shoulder & wrist) from (b)(6) 2016 at an unspecified frequency for sore neck.The patient medical history included leg ulcer and poor circulation.The patient's concomitant medications included paracetamol for leg ulcer pain.The patient wore the thermacare neck should wrist patch after being detailed on the product and when she removed the patch, she had a blister on (b)(6) 2016.Upon follow up the event was reported to be a +-10mm blister in the center at the base of the neck and a +-3mm blister on the right side of the base of the neck.The blisters we painful with surrounding erythema.The patient felt a hot sensation and when she removed the pad eight hours later, the area looked like she had been burnt by a hot object (like a hot iron burn) and experienced pain.It was expected the patient would experience long-term sequelae such as scarring, the patient had pink marks on the areas that had blisters.The patient was using thermacare heatwrap and had a history of poor circulation.No surgical intervention was needed.The blisters were treated with an antiseptic cream, bc56 cream.The action taken in response to the event for thermacare heatwrap was permanently withdrawn on (b)(6) 2016.The outcome of the events +-10mm blister in the center at the base of the neck and a +-3mm blister on the right side of the base of the neck, surrounding erythema, scarring was resolved with sequel on an unspecified date and the outcome of the event using thermacare heatwrap and had a history of poor circulation was unknown.No laboratory tests were performed.The patient was not taking any other relevant medications, including topical medications at the time of the event onset.Additional information has been requested and will be provided as it becomes available.Follow-up (28nov2016): new information received from a pharmacist included patient data (age), relevant medical history, concomitant medications, reaction data (additional events of the area looked like she had been burnt by a hot object (like a hot iron burn)/ 10mm blister in the center at the base of the neck and a +-3mm blister on the right side of the base of the neck, surrounding erythema, scarring, using thermacare heatwrap and had a history of poor circulation, treatment and outcome).Company clinical evaluation comment: based on the information provided, the events of second degree burn and scarring as described in this case are 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 events of erythema and device use error are non-serious and assessed as associated with the use of the device., comment: based on the information provided, the events of second degree burn and scarring as described in this case are 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 events of erythema and device use error are non-serious and assessed as associated with the use of the device.

Manufacturer Narrative

This investigation was conducted for an unknown lot number neck/shoulder/wrist (nsw) 8 hour product.The root cause category is non-assignable (complaint not confirmed as a quality defect).There was limited device specific information provided, no batch number or return sample was available for evaluation.Without a batch reference number and/or return sample a manufacturing and technical evaluation cannot be completed for the wrap involved in this case.There is not a product quality related trend identified for the subclass adverse event safety request for investigation.The 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.

Event Description

Event verbatim [preferred term] area looked like had been burnt by a hot object (like a hot iron burn) and experienced pain/10mm blister in enter at base of neck and a + 3mm blister on right side of base of neck/surrounding erythema [burns second degree] , scarring [scar] , felt a hot sensation and when she removed the pad eight hours later, the area looked like she had been burnt by a hot object (like a hot iron burn) and experienced pain [device issue] , using thermacare heatwrap and had a history of poor circulation [device use error].Case narrative:this is a spontaneous report from a contactable pharmacist received via a sales representative.A 56-year-old female patient started to use thermacare heatwrap (thermacare neck, shoulder & wrist) on (b)(6) 2016 for sore neck.The patient medical history included ongoing leg ulcer pain and ongoing poor circulation.The patient's concomitant medications included paracetamol in the evenings for leg ulcer pain.The patient wore the thermacare neck should wrist patch after being detailed on the product and when she removed the patch, she had a blister on (b)(6) 2016.Upon follow up the event was reported to be a +10mm blister in the center at the base of the neck and a +3mm blister on the right side of the base of the neck.The blisters we painful with surrounding erythema.The patient felt a hot sensation and when she removed the pad eight hours later, the area looked like she had been burnt by a hot object (like a hot iron burn) and experienced pain.It was expected the patient would experience long-term sequelae such as scarring, the patient had pink marks on the areas that had blisters.The patient was using thermacare heatwrap and had a history of poor circulation.No laboratory tests were performed.The patient was not taking any other relevant medications, including topical medications at the time of the event onset.No surgical intervention was needed.The blisters were treated with an antiseptic cream, bc56 cream.The action taken in response to the events for thermacare heatwrap was permanently withdrawn on (b)(6) 2016.The outcome of the event "area looked like had been burnt by a hot object (like a hot iron burn) and experienced pain/10mm blister in enter at base of neck and a + 3mm blister on right side of base of neck/surrounding erythema" was resolved with sequel on (b)(6) 2016.The outcome of the event scarring and "felt a hot sensation and when she removed the pad eight hours later, the area looked like she had been burnt by a hot object (like a hot iron burn) and experienced pain" was resolved with sequel on an unspecified date.The outcome of other event was unknown.According to the product quality complaint group on (b)(6) 2020: this investigation was conducted for an unknown lot number neck/shoulder/wrist (nsw) 8 hour product.The root cause category is non-assignable (complaint not confirmed as a quality defect).There was limited device specific information provided, no batch number or return sample was available for evaluation.Without a batch reference number and/or return sample a manufacturing and technical evaluation cannot be completed for the wrap involved in this case.There is not a product quality related trend identified for the subclass adverse event safety request for investigation.The 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.Follow-up (28nov2016): new information received from a pharmacist included patient data (age), relevant medical history, concomitant medications, reaction data (additional events of the area looked like she had been burnt by a hot object (like a hot iron burn)/ 10mm blister in the center at the base of the neck and a + 3mm blister on the right side of the base of the neck, surrounding erythema, scarring, using thermacare heatwrap and had a history of poor circulation, treatment and outcome).Follow-up (26mar2020): new information received from product quality complaint group includes investigation results., comment: based on the information provided, the events of second degree burn, scarring, device issue and device use error as described in this case are 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 events are assessed as associated with the use of the device.There was limited device specific information provided, no batch number or return sample was available for evaluation.Without a batch reference number and/or return sample a manufacturing and technical evaluation cannot be completed for the wrap involved in this case.Product effect varies with each individual.No remedial action/corrective action/field safety corrective action is suggested at this time.

• Brand Name: THERMACARE NECK, SHOULDER & WRIST
• Type of Device: DISPOSABLE PACK, HOT
• Manufacturer (Section D): PFIZER CONSUMER HEALTH CARE; 1231 wyandotte drive; albany GA 31705
• MDR Report Key: 6145310
• MDR Text Key: 61469405
• Report Number: 1066015-2016-00159
• 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: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 11/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: PARACETAMOL
• Patient Outcome(s): Required Intervention
• Patient Age: 56 YR