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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PFIZER CONSUMER HEALTH CARE ROBAX NECK & SHOULDER HEATWRAP; DISPOSABLE PACK, HOT
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PFIZER CONSUMER HEALTH CARE ROBAX NECK & SHOULDER HEATWRAP; DISPOSABLE PACK, HOT Back to Search Results
Catalog Number 0 62107 33640 6
Device Problem Off-Label Use (1494)
Patient Problems Hemorrhage/Bleeding (1888); Pain (1994); Scarring (2061); Tissue Breakdown (2681)
Event Type  Injury  
Manufacturer Narrative
The root cause category is non-assignable (complaint not confirmed).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 and the product is within expiration date.After a review of the batch thermal records, thermal results all met product release criteria.Consumer alleges she "experienced bleeding and skin peeling off." while using the wrap.The cause of the alleged wrap causing this adverse event is inconclusive since review of records does not provide evidence to support defective product.The product effect may vary with each individual.
 
Event Description
Event verbatim [preferred term] bleeding and skin peeling off [skin haemorrhage] , bleeding and skin peeling off [skin exfoliation] , pain was very bad [pain] , now she had a scar [scar] , using robax neck & shoulder heatwrap for sciatica [device use issue] ,.Case narrative: this is a spontaneous report from a contactable consumer.A female patient of an unspecified age started to receive thermacare heatwrap (robax neck & shoulder heatwrap), device lot number r81802, expiration date may2019, catalog # 0 62107 33640 6 from an unspecified date at an unspecified dose for sciatica and neck problems.The patient medical history and concomitant medications were not reported.The consumer stated that after twenty minutes of wearing product she experienced bleeding and skin peeling off on an unspecified date.Upon follow up it was reported the pain was very bad and now she had a scar on an unspecified date.The action taken in response to the events for thermacare heatwrap was unknown.The outcome of the event scar was not resolved and the outcome of the remaining events was unknown.According to the product quality complaint group: the root cause category is non-assignable (complaint not confirmed).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 and the product is within expiration date.After a review of the batch thermal records, thermal results all met product release criteria.Consumer alleges she "experienced bleeding and skin peeling off." while using the wrap.The cause of the alleged wrap causing this adverse event is inconclusive since review of records does not provide evidence to support defective product.The product effect may vary with each individual.Additional information has been requested and will be provided as it becomes available.Follow-up (28apr2017): new information received from the product quality complaint group included investigational results.Follow-up (25may2017): new information received from the female patient included product data (indications) and reaction data (additional events of pain was very bad, now she had a scar and using robax neck & shoulder heatwrap for sciatica).No follow-up attempts possible.No further information is expected.Follow-up (25apr2017): 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 events of "bleeding and skin peeling off" as described are considered serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure.The events of "pain" "scar" and "device use issue" are non-serious.The events are medically assessed as associated with the use of the device., comment: based on the information provided, the events of "bleeding and skin peeling off" as described are considered serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure.The events of "pain" "scar" and "device use issue" are non-serious.The events are medically assessed as associated with the use of the device.
 
Manufacturer Narrative
The root cause category is non-assignable (complaint not confirmed).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 and the product is within expiration date.After a review of the batch thermal records, thermal results all met product release criteria.Consumer alleges she "experienced bleeding and skin peeling off." while using the wrap.The cause of the alleged wrap causing this adverse event is inconclusive since review of records does not provide evidence to support defective product.The product effect may vary with each individual.
 
Event Description
Event verbatim [preferred term] bleeding and skin peeling off [skin haemorrhage] , bleeding and skin peeling off [skin exfoliation] , pain was very bad [pain] , now she had a scar [scar] , using robax neck & shoulder heatwrap for sciatica [device use issue].Case narrative:this is a spontaneous report from a contactable consumer.A female patient of an unspecified age started to receive thermacare heatwrap (robax neck & shoulder heatwrap), device lot number r81802, expiration date may2019, catalog # 0 62107 33640 6 from an unspecified date at an unspecified dose for sciatica and neck problems.The patient medical history and concomitant medications were not reported.The consumer stated that after twenty minutes of wearing product she experienced bleeding and skin peeling off on an unspecified date.Upon follow up it was reported the pain was very bad and now she had a scar on an unspecified date.The action taken in response to the events for thermacare heatwrap was unknown.The outcome of the event scar was not resolved and the outcome of the remaining events was unknown.According to the product quality complaint group: the root cause category is non-assignable (complaint not confirmed).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 and the product is within expiration date.After a review of the batch thermal records, thermal results all met product release criteria.Consumer alleges she "experienced bleeding and skin peeling off." while using the wrap.The cause of the alleged wrap causing this adverse event is inconclusive since review of records does not provide evidence to support defective product.The product effect may vary with each individual.Follow-up (28apr2017): new information received from the product quality complaint group included investigational results.Follow-up (25may2017): new information received from the female patient included product data (indications) and reaction data (additional events of pain was very bad, now she had a scar and using robax neck & shoulder heatwrap for sciatica).No follow-up attempts possible.No further information is expected.Follow-up (25apr2017): this follow-up report is being submitted to upgrade this case to a reportable mdr.Amendment: this follow-up report is being submitted as a final reportable mdr., comment: based on the information provided, the events of "bleeding and skin peeling off" as described are considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.The events of "pain", "scar" and "device use issue" are non-serious.The events are medically assessed as associated with the use of the device.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 remedial action/corrective action/field safety corrective action is suggested at this time.
 
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Brand Name
ROBAX NECK & SHOULDER HEATWRAP
Type of Device
DISPOSABLE PACK, HOT
Manufacturer (Section D)
PFIZER CONSUMER HEALTH CARE
1231 wyandotte drive
albany GA 31705
MDR Report Key9257605
MDR Text Key181930116
Report Number1066015-2019-00295
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,foreign
Type of Report Initial,Followup
Report Date 04/25/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/30/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Expiration Date05/01/2019
Device Catalogue Number0 62107 33640 6
Device Lot NumberR81802
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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