MAUDE Adverse Event Report: PFIZER CONSUMER HEALTH CARE THERMACARE HEATWRAP; DISPOSABLE PACK, HOT

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Reaction (2414)

Event Type  Injury  

Event Description

She put it directly on her skin and she has a really bad reaction [device use error].Case narrative: this is a spontaneous report from a contactable consumer reporting for herself.This female consumer of an unspecified age started to use thermacare heatwrap (thermacare heatwrap) (device lot number and expiration date not reported) from an unspecified date for an unspecified indication.Relevant medical history and the relevant concomitant medications were unknown at the time of this report.Consumer reported it was entirely her fault but she had a reaction to the wrap.Consumer stated she put wrap directly on her skin and she had a really bad reaction.Consumer reported she did not know what to put on it and she would like to know how to treat this reaction.Consumer stated making a mess and she should rather go to the emergency room.Action taken with the thermacare therapy in response to the event and the outcome of the event were unknown at the time of this report.Additional information has been requested and will be provided as it becomes available.Company clinical evaluation comment: based on the information provided, the event "she put it directly on her skin and she has a really bad reaction" as described is considered serious 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 event "she put it directly on her skin and she has a really bad reaction" as described is considered serious 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] she put it directly on her skin and she has a really bad reaction [device use error] ,.Case narrative:this is a spontaneous report from a contactable consumer reporting for herself.This female consumer of an unspecified age started to use thermacare heatwrap (thermacare heatwrap) (device lot number and expiration date not reported) from an unspecified date for an unspecified indication.Relevant medical history and the relevant concomitant medications were unknown at the time of this report.Consumer reported it was entirely her fault but she had a reaction to the wrap.Consumer stated she put wrap directly on her skin and she had a really bad reaction.Consumer reported she did not know what to put on it and she would like to know how to treat this reaction.Consumer stated making a mess and she should rather go to the emergency room.Action taken with the thermacare therapy in response to the event and the outcome of the event were unknown at the time of this report.According to product quality complaint: reasonably suggest device malfunction was yes and severity of harm was s3.Additional information has been requested and will be provided as it becomes available.Follow-up ((b)(6) 2020): new information received from a product quality complaint group includes: manufacturing site severity and malfunction assessment provided., comment: based on the information provided, the event "she put it directly on her skin and she has a really bad reaction" as described is considered serious 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

Site sample status is not received.Summary of investigation is as follows: this investigation was conducted for an unknown lot number lower back/hip (lbh) 8 hour product.Conclusion is as follows: 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/serious/unknown.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 is that lot trend was not performed as the lot number is unknown.

Event Description

Event verbatim [preferred term] she put it directly on her skin and she has a really bad reaction [device use error].Case narrative:this is a spontaneous report from a contactable consumer reporting for herself.This female consumer of an unspecified age started to use thermacare heatwrap (thermacare heatwrap) (device lot number and expiration date not reported) from an unspecified date for an unspecified indication.Relevant medical history and the relevant concomitant medications were unknown at the time of this report.Consumer reported it was entirely her fault but she had a reaction to the wrap.Consumer stated she put wrap directly on her skin and she had a really bad reaction.Consumer reported she did not know what to put on it and she would like to know how to treat this reaction.Consumer stated making a mess and she should rather go to the emergency room.Action taken with the thermacare therapy in response to the event and the outcome of the event were unknown at the time of this report.According to product quality complaint: reasonably suggest device malfunction was yes and severity of harm was s3.According to product quality complaint group on (b)(6) 2020: site sample status is not received.Summary of investigation is as follows: this investigation was conducted for an unknown lot number lower back/hip (lbh) 8 hour product.Conclusion is as follows: 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/serious/unknown.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 is that lot trend was not performed as the lot number is unknown.Follow-up (10feb2020): new information received from a product quality complaint group includes: manufacturing site severity and malfunction assessment provided.Follow-up (02mar2020): follow-up attempts completed.No further information expected.Follow-up (25mar2020): new information received from product quality complaint group includes: investigation results.Follow-up attempts are completed.No further information is expected., comment: based on the information provided, the event "she put it directly on her skin and she has a really bad reaction" as described is considered serious 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.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.No remedial action/corrective action/field safety corrective action is suggested at this time.Product effect varies with each individual.

• Brand Name: THERMACARE HEATWRAP
• Type of Device: DISPOSABLE PACK, HOT
• Manufacturer (Section D): PFIZER CONSUMER HEALTH CARE; 1231 wyandotte drive; albany GA 31705
• MDR Report Key: 9728374
• MDR Text Key: 189453220
• Report Number: 1066015-2020-00042
• Device Sequence Number: 1
• Product Code: IMD
• Combination Product (y/n): N
• PMA/PMN Number: K953442
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup,Followup
• Report Date: 02/05/2020

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 Received: 02/19/2020
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 02/28/2020; 04/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention