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U.S. Department of Health and Human Services

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

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PFIZER CONSUMER HEALTH CARE THERMACARE NECK, SHOULDER & WRIST; DISPOSABLE PACK, HOT Back to Search Results
Device Problems Overheating of Device (1437); Device Operates Differently Than Expected (2913)
Patient Problem Partial thickness (Second Degree) Burn (2694)
Event Date 12/15/2016
Event Type  Injury  
Event Description
Burn blister [burns second degree] ,.Case narrative:this is a spontaneous report from a contactable consumer via a sales representative.A female patient of an unspecified age and ethnicity started to receive thermacare heatwrap (thermacare neck, shoulder & wrist) via an unspecified route of administration from an unspecified date at 1 dose form, unknown frequency for an unspecified indication.The patient medical history was not reported.The patient's concomitant medications were not reported.The patient developed burn blister from using thermacare heat wrap for the neck on (b)(6) 2016.The heat wrap continued to be hot even after 10 hours.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 burn blister as described in this case is 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 event burn blister as described in this case is 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.
 
Event Description
Event verbatim [preferred term] burn blister [burns second degree] , the heatwrap continued to be hot even after 10 hours [device issue] ,.Case narrative:this is a spontaneous report from a contactable consumer via a sales representative.A female patient of an unspecified age started to receive thermacare heatwrap (thermacare neck, shoulder & wrist) from an unspecified date at 1 dose form, unknown frequency for an unspecified indication.The patient's medical history and concomitant medications were not reported.The patient developed burn blister from using thermacare heatwrap for the neck on (b)(6) 2016.The heatwrap continued to be hot even after 10 hours.Action taken in response to the event for thermacare heatwrap was unknown.The 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 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.Follow-up ( (b)(6) 2017): follow-up attempts completed.No further information expected.Case closed.Follow-up ((b)(6) 2020): new information received from product quality complaints (pqc) group included: product quality investigation results and additional event of device issue., comment: based on the information provided, the event burn blister as described in this case is 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.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.
 
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 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.
 
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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 Key6193004
MDR Text Key62958351
Report Number1066015-2016-00167
Device Sequence Number1
Product Code IMD
Combination Product (y/n)N
PMA/PMN Number
K953442
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,consum
Type of Report Initial,Followup
Report Date 12/15/2016
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? Yes
Device Operator Lay User/Patient
Initial Date Manufacturer Received Not provided
Initial Date FDA Received12/21/2016
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received03/13/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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