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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PFIZER CONSUMER HEALTH CARE ROBAX LOWER BACK & HIP HEATWRAP; DISPOSABLE PACK, HOT
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PFIZER CONSUMER HEALTH CARE ROBAX LOWER BACK & HIP HEATWRAP; DISPOSABLE PACK, HOT Back to Search Results
Catalog Number 0 62107 33630 7
Device Problems Connection Problem (2900); Physical Resistance/Sticking (4012)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  Injury  
Event Description
There was a piece of thin paper like a net connected to the product/it is attached very tight [device issue].Case narrative: this is a spontaneous report from a contactable consumer.This female consumer of unknown age started to receive thermacare heatwrap (robax lower back & hip heatwrap) lot: aa2383, exp: oct2021, from unknown date for unknown indication.Medical history and concomitant medications were not reported.Consumer had the robax lower back relief heat wraps and she stated there was a piece of thin paper like a net connected to the product.She stated it was attached very tight and she didn't know which was side was the inside or the outside.The action taken in response to the event of the product 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 patient reported "there was a piece of thin paper like a net connected to the product/it is attached very tight" as described is a potential device malfunction and considered serious may cause bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.The event is medically assessed as associated with the use of the device.Comment: based on the information provided, the patient reported "there was a piece of thin paper like a net connected to the product/it is attached very tight" as described is a potential device malfunction and considered serious may cause bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.The event is medically assessed as associated with the use of the device.
 
Event Description
Event verbatim [preferred term] there was a piece of thin paper like a net connected to the product/it is attached very tight [device issue].Case narrative:this is a spontaneous report from a contactable consumer.This female consumer of unknown age started to receive thermacare heatwrap (robax lower back & hip heatwrap) lot: aa2383, exp: oct2021, from unknown date for unknown indication.Medical history and concomitant medications were not reported.Consumer had the robax lower back relief heat wraps and she stated there was a piece of thin paper like a net connected to the product.She stated it was attached very tight and she didn't know which was side was the inside or the outside.The action taken in response to the event of the product was unknown.The outcome of the event was unknown.Additional information has been requested and will be provided as it becomes available.Follow-up (24feb2020): this follow-up is being submitted to notify that the investigation is still ongoing., comment: based on the information provided, the patient reported "there was a piece of thin paper like a net connected to the product/it is attached very tight" as described is a potential device malfunction and considered serious may cause bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.The event is medically assessed as associated with the use of the device.
 
Manufacturer Narrative
The root cause category is non assignable (complaint not confirmed).The cause of the adverse event is inconclusive since review of records does not provide evidence to support defective product.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.The product quality for the batch is not impacted by this complaint.
 
Event Description
Event verbatim [preferred term] there was a piece of thin paper like a net connected to the product/it is attached very tight [device issue].Case narrative:this is a spontaneous report from a contactable consumer.This female consumer of unknown age started to receive thermacare heatwrap (robax lower back & hip heatwrap) lot: aa2383, exp: oct2021, from unknown date for unknown indication.Medical history and concomitant medications were not reported.Consumer had the robax lower back relief heat wraps and she stated there was a piece of thin paper like a net connected to the product.She stated it was attached very tight and she didn't know which was side was the inside or the outside.The action taken in response to the event of the product was unknown.The outcome of the event was unknown.According to product quality complaint group: conclusion: the root cause category is non assignable (complaint not confirmed).The cause of the adverse event is inconclusive since review of records does not provide evidence to support defective product.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.The product quality for the batch is not impacted by this complaint.Follow-up (24feb2020): this follow-up is being submitted to notify that the investigation is still ongoing.Follow-up (17jan2020): new information received from product quality complaint group included: investigation results., comment: based on the information provided, the patient reported "there was a piece of thin paper like a net connected to the product/it is attached very tight" as described is a potential device malfunction and considered serious may cause bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.The event is 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 remedial action/corrective action/field safety corrective action is suggested at this time.
 
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Brand Name
ROBAX LOWER BACK & HIP HEATWRAP
Type of Device
DISPOSABLE PACK, HOT
Manufacturer (Section D)
PFIZER CONSUMER HEALTH CARE
1231 wyandotte drive
albany GA 31705
MDR Report Key9563855
MDR Text Key188825292
Report Number1066015-2019-00568
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,Followup
Report Date 12/27/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/08/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Expiration Date10/01/2021
Device Catalogue Number0 62107 33630 7
Device Lot NumberAA2383
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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