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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
Lot Number L16816
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Death (1802); Injury (2348)
Event Type  Injury  
Manufacturer Narrative
The root cause category is non-assignable (complaint not confirmed).After a review of the batch records, batch met all product release criteria.Consumer reports an adverse event "a heat wrap caused severe skin injury at the shoulder area".The cause of the adverse event is inconclusive since review of records does not provide evidence to support defective product.The product effect may vary with each individual.The plant has reviewed this batch from a manufacturing perspective.No quality issues were identified upon this review of batch records, release testing data or, inspection of retained samples.Retained samples met the product description.Batch l16816 expired on january 31,2018.The product quality for the batch is not impacted by this complaint.
 
Event Description
Event verbatim [preferred term] severe skin injury at the shoulder area [skin injury] ,.Case narrative: this is a spontaneous report from a contactable pharmacist.A male patient of an unspecified age started to use thermacare heatwrap (thermacare neck, shoulder & wrist) (device lot number: l16816, expiration date: jan2018) from an unspecified date for an unspecified indication.The patient's medical history and concomitant medications were not reported.The patient used thermacare heatwrap for four hours and had experienced severe skin injury at the shoulder area on an unspecified date.He had to be treated due to this injury by a home care worker.He will probably sue pfizer pch for that.He has photos documenting the injury on his digital camera.Upon follow-up on 19jun2018, the pharmacist reported, "unfortunately, we cannot make any further details on the case because the person died shortly after his visit." action taken in response to the event for thermacare heatwrap was unknown.Unspecified therapeutic measures were taken as a result of severe skin injury at the shoulder area.Clinical outcome of the event was unknown.According to the product quality complaint group: the root cause category is non-assignable (complaint not confirmed).After a review of the batch records, batch met all product release criteria.Consumer reports an adverse event "a heat wrap caused severe skin injury at the shoulder area".The cause of the adverse event is inconclusive since review of records does not provide evidence to support defective product.The product effect may vary with each individual.The plant has reviewed this batch from a manufacturing perspective.No quality issues were identified upon this review of batch records, release testing data or, inspection of retained samples.Retained samples met the product description.Batch l16816 expired on january 31,2018.The product quality for the batch is not impacted by this complaint.Additional information has been requested and will be provided as it becomes available.Follow-up (30apr2018): new information received from the product quality complaint group included investigational results.Follow-up (19jun2018): new information received from the contactable pharmacist includes: patient details.Follow-up (10apr2018): this follow-up report is being submitted to upgrade this case to a reportable mdr.Company clinical evaluation comment: based on the information provided, the event of "severe skin injury at the shoulder area" as described is considered serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure.A causal relationship between the device and the event cannot be ruled out.The review of the lot/batch records does not suggest a defect or quality issue related to the manufacture of this lot.No device malfunction has been identified.No further investigations or actions is suggested at this time., comment: based on the information provided, the event of "severe skin injury at the shoulder area" as described is considered serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure.A causal relationship between the device and the event cannot be ruled out.The review of the lot/batch records does not suggest a defect or quality issue related to the manufacture of this lot.No device malfunction has been identified.No further investigations or actions is suggested at this time.
 
Manufacturer Narrative
The root cause category is non-assignable (complaint not confirmed).After a review of the batch records, batch met all product release criteria.Consumer reports an adverse event "a heat wrap caused severe skin injury at the shoulder area".The cause of the adverse event is inconclusive since review of records does not provide evidence to support defective product.The product effect may vary with each individual.The plant has reviewed this batch from a manufacturing perspective.No quality issues were identified upon this review of batch records, release testing data or, inspection of retained samples.Retained samples met the product description.Batch l16816 expired on january 31,2018.The product quality for the batch is not impacted by this complaint.
 
Event Description
Event verbatim [preferred term] severe skin injury at the shoulder area [skin injury] ,.Case narrative:this is a spontaneous report from a contactable pharmacist.A male patient of an unspecified age started to use thermacare heatwrap (thermacare neck, shoulder & wrist) (device lot number: l16816, expiration date: 31jan2018) from an unspecified date for an unspecified indication.The patient's medical history and concomitant medications were not reported.The patient used thermacare heatwrap for four hours and had experienced severe skin injury at the shoulder area on an unspecified date.He had to be treated due to this injury by a home care worker.He will probably sue pfizer pch for that.He has photos documenting the injury on his digital camera.Upon follow-up on (b)(6) 2018, the pharmacist reported, "unfortunately, we cannot make any further details on the case because the person died shortly after his visit." action taken in response to the event for thermacare heatwrap was unknown.Unspecified therapeutic measures were taken as a result of severe skin injury at the shoulder area.Clinical outcome of the event was unknown.According to the product quality complaint group: the root cause category is non-assignable (complaint not confirmed).After a review of the batch records, batch met all product release criteria.Consumer reports an adverse event "a heat wrap caused severe skin injury at the shoulder area".The cause of the adverse event is inconclusive since review of records does not provide evidence to support defective product.The product effect may vary with each individual.The plant has reviewed this batch from a manufacturing perspective.No quality issues were identified upon this review of batch records, release testing data or, inspection of retained samples.Retained samples met the product description.Batch l16816 expired on january 31,2018.The product quality for the batch is not impacted by this complaint.Follow-up attempts are completed.No further information is expected.Follow-up (b)(6) 2018: new information received from the product quality complaint group included investigational results.Follow-up (b)(6) 2018: new information received from the contactable pharmacist includes: patient details.Follow-up (10apr2018): this follow-up report is being submitted to upgrade this case to a reportable mdr.Follow-up (b)(6) 2019): this follow-up report is being submitted as a final reportable mdr., comment: based on the information provided, the event of "severe skin injury at the shoulder area" as described is considered serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure.The root cause category is non-assignable (complaint not confirmed).After a review of the batch records, batch met all product release criteria.The cause of the adverse event is inconclusive since review of records does not provide evidence to support defective product.Product effect varies with each individual.No further investigations or actions are suggested at this time.
 
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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 Key9260007
MDR Text Key185223635
Report Number1066015-2019-00423
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 foreign,health professional
Type of Report Initial,Followup
Report Date 04/10/2018
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? No
Device Operator Lay User/Patient
Device Expiration Date01/31/2018
Device Lot NumberL16816
Was Device Available for Evaluation? No
Initial Date Manufacturer Received Not provided
Initial Date FDA Received10/31/2019
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received12/24/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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