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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 Break (1069); Leak/Splash (1354)
Patient Problems Burn, Thermal (2530); Chemical Exposure (2570)
Event Date 01/01/2018
Event Type  malfunction  
Event Description
Event verbatim [preferred term] she put it on, one of it burnt her neck while little spots on her neck or something [thermal burn] , she put it on, one of it burnt her neck while little spots on her neck or something [device leakage] ,.Case narrative:this is a spontaneous report from a non-contactable consumer reporting for a patient.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 to an unspecified date for pain.Regarding medical history the reporter stated "i believe she is diabetic.I am not 100% sure.I just noticed she might be diabetic".The patient's concomitant medications were not reported.The patient had the thermacare heating pads and when she put it on, one of it burnt her neck while little spots on her neck or something, it happened about 3 weeks or so or may be a month before (2018).The patient skin tone was very light or fair.When asked which version of thermacare were patient using like back/hip hand/wrist neck/shoulder/wrist knee/elbow menstrual the reporter stated, "i believe it's neck." the patient may use the thermacare before and the reporter stated the same problem may be not occurred because the patient liked the product.When probed for the situation that applied while patient were wearing thermacare the reporter stated, "i think she cold a lot.She was wearing several layers but i don't know if at that time she was wearing the layers or she was at home." regarding if the patient read the usage instructions on thermacare before using the product the reporter stated, "i don't know.I would assume so because she has used the product before".The action taken for the product and events outcome was unknown.Additional information has been requested and will be provided as it becomes available.Follow-up (23oct2018): this follow-up report is being submitted to upgrade this case to a reportable mdr.Company clinical evaluation comment based on available information, the reported device leakage was associated with the event burn, and represents a potential device malfunction.The events are associated with use of device., comment: based on available information, the reported device leakage was associated with the event burn, and represents a potential device malfunction.The events are associated with use of device.
 
Manufacturer Narrative
Site sample was not received.Summary of investigation: this investigation was conducted for an unknown lot number neck/shoulder/wrist (nsw) 8hr product.Conclusion: 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.Lot trend assmt.& rationale: a lot trend was not performed.The lot number is unknown.
 
Event Description
Event verbatim [preferred term], she put it on, one of it burnt her neck while little spots on her neck or something [thermal burn], she put it on, one of it burnt her neck while little spots on her neck or something [device leakage], narrative: this is a spontaneous report from a non-contactable consumer reporting for a patient.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 to an unspecified date for pain.Regarding medical history included the reporter stated "i believe she is diabetic.I am not 100% sure.I just noticed she might be diabetic".The patient's concomitant medications were not reported.The patient had the thermacare heating pads and when she put it on, one of it burnt her neck while little spots on her neck or something, it happened about 3 weeks or so or may be a month before (2018).The patient skin tone was very light or fair.When asked which version of thermacare were patient using like back/hip hand/wrist neck/shoulder/wrist knee/elbow menstrual the reporter stated, "i believe it's neck." the patient may use the thermacare before and the reporter stated the same problem may be not occurred because the patient liked the product.When probed for the situation that applied while patient were wearing thermacare the reporter stated, "i think she cold a lot.She was wearing several layers but i don't know if at that time she was wearing the layers or she was at home." regarding if the patient read the usage instructions on thermacare before using the product the reporter stated, "i don't know.I would assume so because she has used the product before".The action taken for the product and events outcome was unknown.According to product quality complaint group: site sample was not received.Summary of investigation: this investigation was conducted for an unknown lot number neck/shoulder/wrist (nsw) 8hr product.Conclusion: 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.Lot trend assmt.& rationale: a lot trend was not performed.The lot number is unknown.Follow-up (23oct2018): this follow-up report is being submitted to upgrade this case to a reportable mdr.Follow-up (13nov2019): no follow-up attempts are possible.No further information is expected.Follow-up (03jul2020): no follow-up attempts are possible.No further information is expected.Follow-up (11jul2020): new information received from product quality complaint group includes investigation results.No follow-up attempts are possible.No further information is expected.
 
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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 Key9260679
MDR Text Key220289232
Report Number1066015-2019-00409
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
Report Date 10/23/2018
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? Yes
Device Operator Lay User/Patient
Initial Date Manufacturer Received Not provided
Initial Date FDA Received10/31/2019
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received07/15/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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