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

Device Problem Insufficient Information (3190)

Patient Problems Burn, Thermal (2530); Partial thickness (Second Degree) Burn (2694)

Event Date 12/01/2018

Event Type  Injury  

Event Description

Event verbatim [preferred term] massive burn blister / blisters over the area of the neck [burns second degree].Case narrative: this is a spontaneous report from a contactable pharmacist.A female patient of an unspecified age started to receive thermacare heatwrap (thermacare neck, shoulder & wrist), from an unspecified date at unknown frequency for an unspecified indication.The patient medical history and concomitant medications were not reported.The pharmacist reported very bad and strong reaction for the patient who bought the product.In (b)(6) 2018 the patient suffered from burn blister.The burn blisters were massive.After using it she had blisters over the area of the neck.The pharmacist was asking for information which they can provide to the patient in order to relax the situation.He said that if the patient didn't receive some information on this she may refer to a law suit.The action taken in response to the event for thermacare heatwrap was unknown.The outcome of the event 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 event of burns second degree as described is considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.The event is medically assessed as associated with the use of the device., comment: based on the information provided, the event of burns second degree as described is considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.The event is medically assessed as associated with the use of the device.

Manufacturer Narrative

There is no impact since a trend for the subclass adverse event was not identified.The root cause category is non-assignable (complaint not confirmed).The product effect may vary with each individual.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.

Event Description

Massive burn blister/blisters over the area of the neck/severe burns blisters up to the flesh open [burns second degree].Case narrative:this is a spontaneous report from a contactable pharmacist.A 60-year-old female patient started to receive thermacare heatwrap (thermacare neck, shoulder & wrist), from an unspecified date to an unspecified date at unknown frequency for an unspecified indication.The patient medical history included rheumatoid arthritis.There were no concomitant medications.The pharmacist reported very bad and strong reaction for the patient who bought the product.In dec2018 the patient suffered from burn blister.The burn blisters were massive.After using it she had blisters over the area of the neck.The pharmacist was asking for information which they can provide to the patient in order to relax the situation.He said that if the patient didn't receive some information on this she may refer to a law suit.The pharmacist further reported that the event had been described as severe burns blisters up to the flesh open which occurred for the first time.Surgery or another type of treatment was not required.The pharmacist suspected that the patient will have scars due to the event.The action taken in response to the event for thermacare heatwrap was permanently withdrawn.The outcome of the event was not resolved.Causality had been assessed as related by the pharmacist.According to product quality complaint group: there is no impact since a trend for the subclass adverse event was not identified.The root cause category is non-assignable (complaint not confirmed).The product effect may vary with each individual.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.Follow-up (14jan2019): new information received from the same contactable pharmacist includes: patient data (age, weight and height), medical history, concomitant drug data, suspect device data (action taken), outcome of event, event details and causality assessment.Follow-up attempts completed.No further information expected.Follow-up (23jan2019): new information received from product quality complaint group included: investigational results.Company clinical evaluation comment: based on the information provided, the event of burns second degree as described is considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.The event is medically 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., comment: based on the information provided, the event of burns second degree as described is considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.The event is medically 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.

Event Description

Event verbatim [preferred term] massive burn blister/blisters over the area of the neck/severe burns blisters up to the flesh open [burns second degree] ,.Case narrative:this is a spontaneous report from a contactable pharmacist.A 60-year-old female patient started to receive thermacare heatwrap (thermacare neck, shoulder & wrist), from an unspecified date to an unspecified date at unknown frequency for an unspecified indication.The patient medical history included rheumatoid arthritis.There were no concomitant medications.The pharmacist reported very bad and strong reaction for the patient who bought the product.In dec2018 the patient suffered from burn blister.The burn blisters were massive.After using it she had blisters over the area of the neck.The pharmacist was asking for information which they can provide to the patient in order to relax the situation.He said that if the patient didn't receive some information on this she may refer to a law suit.The pharmacist further reported that the event had been described as severe burns blisters up to the flesh open which occurred for the first time.Surgery or another type of treatment was not required.The pharmacist suspected that the patient will have scars due to the event.The action taken in response to the event for thermacare heatwrap was permanently withdrawn.The outcome of the event was not resolved.Causality had been assessed as related by the pharmacist.Follow-up (14jan2019): new information received from the same contactable pharmacist includes: patient data (age, weight and height), medical history, concomitant drug data, suspect device data (action taken), outcome of event, event details and causality assessment.Follow-up attempts completed.No further information expected.Company clinical evaluation comment: based on the information provided, the event of burns second degree as described is considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.The event is medically assessed as associated with the use of the device., comment: based on the information provided, the event of burns second degree as described is considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.The event is medically assessed as associated with the use of the device.

• 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: 8195774
• MDR Text Key: 131479148
• Report Number: 1066015-2018-00209
• 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: foreign,health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 12/19/2018

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?: No
• Device Operator: Lay User/Patient
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/26/2018
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 01/18/2019; 01/28/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 60 YR