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

Device Problem Defective Device (2588)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  Injury  

Event Description

Wears these from early morning to midnight and not only are they still hot when the patient removes them [device issue], the neck wrap is much more versatile and i use it on specific areas over hip and knee joints as well as shoulder line [intentional device use issue], wear these from early morning to midnight [device use error].Case narrative: this is a spontaneous report from a pfizer-sponsored program thermacare power reviews, received from a contactable consumer.A patient of unspecified age and gender started to use thermacare heatwrap (thermacare neck, shoulder & wrist) from an unspecified date for an unspecified indication.The patient's medical history included long term chronic pain in spine and joints now aggravated by arthritis with accompanying stiffness.The patient's concomitant medications were not reported.The patient rated thermacare heatwrap "5 stars.Always dependable and always in my home cabinet." the consumer reported "the best on the market in my opinion and believe me, i've tried them all!" the consumer had long term chronic pain in spine and joints now aggravated by arthritis with accompanying stiffness and the warmth provided by these wraps was a constant companion.The patient had both the large back wraps and these smaller neck wraps, and both serve well, but the neck wrap was much more versatile and the patient used it on specific areas over hip and knee joints as well as shoulder line."the claim they make of 16 hours of warmth is not exaggerated." the patient wears these from early morning to midnight and not only are they still hot when the patient removes them, the patient did not suffer any irritation from the adhesive.The patient always keeps a ready supply on hand and hate to be without them, certainly in winter months.Action taken with thermacare heatwrap was unknown.Outcome of the event was unknown.Additional information has been requested and will be provided as it becomes available was entered to the end of the narrative.Company clinical evaluation comment: based on the information provided, the event "wears these from early morning to midnight and not only are they still hot when the patient removes them" (device issue) as described is considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.The other events intentional device use issue and device use error are non-serious.The events are medically assessed as associated with the use of the device.Comment: based on the information provided, the event "wears these from early morning to midnight and not only are they still hot when the patient removes them" (device issue) as described is considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.The other events intentional device use issue and device use error are non-serious.The events are medically assessed as associated with the use of the device.

Event Description

Event verbatim [preferred term] wears these from early morning to midnight and not only are they still hot when the patient removes them [device issue] , the neck wrap is much more versatile and i use it on specific areas over hip and knee joints as well as shoulder line [intentional device use issue] , wear these from early morning to midnight [device use error].Case narrative:this is a spontaneous report from a pfizer-sponsored program, thermacare power reviews.A contactable consumer reported a patient of unspecified age and gender started to use thermacare heatwrap (thermacare neck, shoulder & wrist) from an unspecified date for an unspecified indication.The patient's medical history included long term chronic pain in spine and joints now aggravated by arthritis with accompanying stiffness.The patient's concomitant medications were not reported.The patient rated thermacare heatwrap "5 stars.Always dependable and always in my home cabinet." the consumer reported "the best on the market in my opinion and believe me, i've tried them all!" the consumer had long term chronic pain in spine and joints now aggravated by arthritis with accompanying stiffness and the warmth provided by these wraps was a constant companion.The patient had both the large back wraps and these smaller neck wraps, and both serve well, but the neck wrap was much more versatile and the patient used it on specific areas over hip and knee joints as well as shoulder line."the claim they make of 16 hours of warmth is not exaggerated." the patient wears these from early morning to midnight and not only are they still hot when the patient removes them, the patient did not suffer any irritation from the adhesive.The patient always keeps a ready supply on hand and hate to be without them, certainly in winter months.Action taken with thermacare heatwrap was unknown.Outcome of the event was unknown.Additional information received from product quality complaint (pqc) group included investigation results.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/serious/unknown.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 (21feb2020): new information received from product quality complaints (pqc) group included: product quality investigation results.Follow-up attempts are completed.No further information is expected., comment: based on the information provided, the complaint of "wears these from early morning to midnight and not only are they still hot when the patient removes them" (device issue) as described is considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.The other complaints of intentional device use issue and device use error are non-serious.A causal relationship between the device and the complaints cannot be ruled out.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.Is not a product quality related trend identified.No further investigations or actions is suggested at this time.

Manufacturer Narrative

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/serious/unknown.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.

• 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: 9492139
• MDR Text Key: 188330971
• Report Number: 1066015-2019-00553
• 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: consumer
• Type of Report: Initial,Followup
• Report Date: 12/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/18/2019
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention