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

Device Problem Overheating of Device (1437)

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

Event Type  Injury  

Event Description

Too hot or too warm [device issue] ,.Case narrative:this is a spontaneous report from a non-contactable consumer.This consumer of an unspecified age and gender started to use thermacare heatwrap (thermacare neck, shoulder & wrist) (device lot number and expiration date not provided) from an unspecified date for pain management.Relevant medical history and the relevant concomitant medications were unknown at the time of this report.Consumer commented thermacare heatwraps neck wirst and shoulder 12 hours was good while the 8hr was too hot or too warm.It did not burn consumer skin but it was hot.Consumer reported some people told to take it off after a couple of hours and put it back on.Consumer went to the pharmacist.Action taken with the thermacare therapy in response to the event and the outcome of the event were unknown at the time of this report.Additional information has been requested and will be provided as it becomes available., comment: the complaint of "too hot or too warm" is considered a potential device malfunction which has a theoretical risk to cause skin burn, or likely to cause and/or contribute to a serious injury.No adverse event was associated with the use of the device.A causal relationship between the device and the event cannot be ruled out.This case will be re-assessed upon receipt of additional information.

Manufacturer Narrative

This investigation was conducted for an unknown lot number neck/shoulder/wrist (nsw) 8hr 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 wrap/patch/pad too hot.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.Lot trend assmt.& rationale: a lot trend was not performed as the lot number is unknown.Site sample status is not received.

Event Description

Event verbatim [preferred term] too hot or too warm/ 8hr was too hot or too warm [device issue] , people told me to take it off after a couple of hours and put it back on.[device use error] ,.Case narrative:this is a spontaneous report from a non-contactable consumer.This consumer of an unspecified age and gender started to use thermacare heatwrap (thermacare neck, shoulder & wrist) (device lot number and expiration date not provided) from an unspecified date for an unspecified indication.Relevant medical history and the relevant concomitant medications were unknown at the time of this report.Consumer commented thermacare heatwraps neck wrist and shoulder 12 hours was good while the 8hr was too hot or too warm.It did not burn consumer's skin, but it was hot.Consumer reported some people told to take it off after a couple of hours and put it back on.Consumer went to the pharmacist.Action taken with the thermacare therapy in response to the event and the outcome of the event were unknown at the time of this report.Follow-up ((b)(6)2020): this is a follow-up report combining information from duplicate reports 2020086723 and 2020075846.The current and all subsequent information will be reported under manufacturer report number (b)(4).This is a spontaneous report from a non-contactable consumer.A patient of unspecified age and gender started to use thermacare heatwrap (thermacare heatwrap) from an unspecified date for an unspecified indication.The patient's medical history and concomitant medications were not reported.The patient reported the 16hr heatwrap was good, but the one for 8hr was too hot or too warm on an unspecified date.It did not burn his/her skin but it was hot.People told him/her to take it off after a couple of hours and put it back on.The consumer went to the pharmacist.Made a real small pack.Action taken in response to the event for thermacare heatwrap was unknown.The outcome of the 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) 8hr 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 wrap/patch/pad too hot.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.Lot trend assmt.& rationale: a lot trend was not performed as the lot number is unknown.Site sample status is not received.Follow-up ((b)(6)2020): 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., comment: the complaint of "too hot or too warm" is considered a potential device malfunction which has a theoretical risk to cause skin burn, or likely to cause and/or contribute to a serious injury.No adverse event was associated with the use of the device.The event device use error is non-serious.A causal relationship between the device and the events 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.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: 9794812
• MDR Text Key: 191290875
• Report Number: 1066015-2020-00054
• 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: 02/19/2020

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: 03/05/2020
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention