• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

PFIZER CONSUMER HEALTH CARE THERMACARE NECK, SHOULDER & WRIST; DISPOSABLE PACK, HOT Back to Search Results
Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)
Patient Problems Pain (1994); Burn, Thermal (2530)
Event Type  Injury  
Event Description
Event verbatim [preferred term]; burns on my neck [thermal burn], my neck is more painful than before [neck pain], my neck is more painful than before [condition aggravated].Case narrative: this is a spontaneous report from a contactable consumer.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 an unspecified dose for neck pain.The patient medical history was not reported.The patient's concomitant medications were not reported.The patient bought the neck wraps due to a sudden onset of neck pain, and after 8 hours removed it.The next day, she had burns on her neck and had to go back to the pharmacy for burn cream.She used the patch according to the instructions and now her neck was more painful than before.The outcome of the events 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 reported event thermal burn as described in this case is considered 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 other events neck pain and condition aggravated are assessed as associated with the device use.Comment: based on the information provided, the reported event thermal burn as described in this case is considered 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 other events pain and condition aggravated are assessed as associated with the device use.
 
Event Description
Event verbatim [preferred term] burns on my neck [thermal burn] , my neck is more painful than before [neck pain] , my neck is more painful than before [condition aggravated], case narrative:this is a spontaneous report from a contactable consumer.A female patient of an unspecified age started to receive thermacare heatwrap (thermacare neck, shoulder & wrist) via an unspecified route of administration from an unspecified date at an unspecified dose for neck pain.The patient medical history was not reported.The patient's concomitant medications were not reported.The patient bought the neck wraps due to a sudden onset of neck pain, and after 8 hours removed it.The next day she had burns on her neck and had to go back to the pharmacy for burn cream.She used the patch according to the instructions and now her neck was more painful than before.The outcome of the events was unknown.Additional information has been requested and will be provided as it becomes available.Amendment: this follow-up report is being submitted to amend previously reported information: malfunction was left blank.Company clinical evaluation comment based on the information provided, the reported event thermal burn as described in this case is considered 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 other events neck pain and condition aggravated are assessed as associated with the device use., comment: based on the information provided, the reported event thermal burn as described in this case is considered 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 other events pain and condition aggravated are assessed as associated with the device use.
 
Event Description
Event verbatim [preferred term]; burns on my neck [thermal burn], my neck is more painful than before [neck pain], my neck is more painful than before [condition aggravated], narrative: this is a spontaneous report from a contactable consumer.A female patient of an unspecified age started to use thermacare heatwrap (thermacare neck, shoulder & wrist) from an unspecified date for neck pain.The patient's medical history and concomitant medications were not reported.The patient bought the neck wraps due to a sudden onset of neck pain, and after 8 hours removed it.The next day she had burns on her neck and had to go back to the pharmacy for burn cream.She used the patch according to the instructions and now her neck was more painful than before.The outcome of the events 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 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.Site sample status: not received amendment: this follow-up report is being submitted to amend previously reported information: malfunction was left blank.Follow-up (30apr2020): 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 reported event thermal burn as described in this case is considered 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 other events pain and condition aggravated are assessed as associated with the device use.
 
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 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.Site sample status: not received.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key6169302
MDR Text Key62221842
Report Number1066015-2016-00164
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 consumer
Type of Report Initial,Followup,Followup
Report Date 12/01/2016
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? No
Device Operator Lay User/Patient
Initial Date Manufacturer Received Not provided
Initial Date FDA Received12/13/2016
Supplement Dates Manufacturer ReceivedNot provided
Not provided
Supplement Dates FDA Received11/14/2019
05/06/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
-
-