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

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Burn, Thermal (2530)

Event Type  Injury  

Event Description

Is it normal for them to burn you [thermal burn].Case narrative: this is a spontaneous report from a non contactable consumer via pfizer-sponsored program thermacare (b)(6) page.This consumer of unspecified age and gender started to receive thermacare heatwrap (unspecified trade name) on an unknown date for unspecified indication.Relevant medical history and concomitant medications were not reported.The consumer reported."it is normal for them to burn you?".The action taken with thermacare heatwrap and outcome of the event were unknown.Additional information has been requested and will be provided as it becomes available.Comment: based on the information provided, the event 'burn' 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] is it normal for them to burn you [thermal burn].Case narrative:this is a spontaneous report from a non-contactable consumer via pfizer-sponsored program thermacare facebook page.This consumer of unspecified age and gender started to receive thermacare heatwrap (thermacare heatwrap) on an unknown date for an unspecified indication.Relevant medical history and concomitant medications were not reported.The consumer reported, "it is normal for them to burn you?" the action taken with thermacare heatwrap and outcome of the event were unknown.Additional information has been requested and will be provided as it becomes available.Follow-up (06mar2020): new information received from a product quality complaint group includes: this case is a reportable malfunction., comment: based on the information provided, the event 'burn' 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] is it normal for them to burn you [thermal burn].Case narrative:this is a spontaneous report from a non-contactable consumer via pfizer-sponsored program thermacare facebook page.This consumer of unspecified age and gender started to receive thermacare heatwrap (thermacare heatwrap) on an unknown date for an unspecified indication.Relevant medical history and concomitant medications were not reported.The consumer reported, "it is normal for them to burn you?" the action taken with thermacare heatwrap and outcome of the event were unknown.Product investigation results were as follows: 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.No 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, finished product quality.Full investigation was not performed as providing the batch record information as is the manufacturing site's requirement.Therefore, a summary investigation was performed.Based on the complaint narrative, the patient experienced a burn with product use.Review of complaint description concludes there was a reportable malfunction.A return sample has not been received at the site for evaluation as of (b)(6) 2020.Reasonably suggest device malfunction: yes.Severity of harm: s3.Follow-up (06mar2020): new information received from a product quality complaint group includes: this case is a reportable malfunction.Follow-up (10apr2020): new information reported from product quality complaints group includes product investigation results.Comment: based on the information provided, the event 'burn' 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.Product effect varies with each individual.No remedial action/corrective action/field safety corrective action is suggested at this time.

Manufacturer Narrative

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.No 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, finished product quality.Full investigation was not performed as providing the batch record information as is the manufacturing site's requirement.Therefore, a summary investigation was performed.Based on the complaint narrative, the patient experienced a burn with product use.Review of complaint description concludes there was a reportable malfunction.A return sample has not been received at the site for evaluation as of 09mar2020.Reasonably suggest device malfunction: yes.Severity of harm: s3.

• 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: 9829316
• MDR Text Key: 190337437
• Report Number: 1066015-2020-00065
• 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: 02/27/2020

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: 03/13/2020
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 03/18/2020; 04/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention