MAUDE Adverse Event Report: PFIZER CONSUMER HEALTH CARE THERMACARE LOWER BACK & HIP; DISPOSABLE PACK, HOT

Device Problem Overheating of Device (1437)

Patient Problems Inflammation (1932); Scarring (2061); No Code Available (3191)

Event Date 11/12/2013

Event Type  Injury  

Event Description

So hot that when i took it off i had red marks.This morning, i now have a blister and the red marks [blister] , the product was so hot [device issue] , still have the scars [scar].Case narrative: this is a spontaneous report from a contactable consumer.An adult female patient of an unspecified age started to use thermacare heatwrap (thermacare lower back & hip) from an unspecified date for back pain.The patient's medical history and concomitant medications were not reported.The patient reported on (b)(6) 2013, she wore one that was so hot that when she took it off she had red marks.In the morning of (b)(6) 2013, she had a blister and the red marks.She had taken a photo.Action taken with thermacare heatwrap was unknown.The patient provided photographs of the affected area that had not recovered from the events.Upon follow-up received from the consumer on 16oct2019, it was reported some years ago, the product gave her blisters and it was so hot and she still has the scars.Additional information has been requested and will be provided as it becomes available.Follow-up (15nov2013): additional information from the consumer includes that this event occurred in (b)(6) (previously reported country of incidence was united states) and reaction data (outcome of the events).Follow-up (23jan2014): follow-up attempts completed.No further information expected.Follow-up (16oct2019): new information received from the same contactable consumer includes: reaction data (additional event scar).This case was upgraded to a reportable mdr.Company clinical evaluation comment: based on the information provided, the events of blister, device issue and scar as described are considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.The events are medically assessed as associated with the use of the device., comment: based on the information provided, the events of blister, device issue and scar as described are considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.The events are medically assessed as associated with the use of the device.

Event Description

Event verbatim [preferred term] so hot that when i took it off i had red marks.This morning, i now have a blister and the red marks [blister] , the product was so hot [device issue] , still have the scars [scar].Case narrative:this is a spontaneous report from a contactable consumer.An adult female patient of an unspecified age started to use thermacare heatwrap (thermacare lower back & hip) from an unspecified date for back pain.The patient's medical history and concomitant medications were not reported.The patient reported on (b)(6) 2013, she wore one that was so hot that when she took it off she had red marks.In the morning of (b)(6) 2013, she had a blister and the red marks.She had taken a photo.Action taken with thermacare heatwrap was unknown.The patient provided photographs of the affected area that had not recovered from the events.Upon follow-up received from the consumer on (b)(6) 2019, it was reported some years ago, the product gave her blisters and it was so hot and she still has the scars.Product investigation results were as follows: conclusion: this investigation was conducted for an unknown lot number lower back/hip (lbh) 8 hour product.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 wrap/patch/pad too hot.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.Based on the complaint narrative, the patient developed red marks on skin as the product was too hot.Review of complaint description concludes there is no device malfunction.Severity of harm reported as s3.Additional information has been requested and will be provided as it becomes available.Follow-up (15nov2013): additional information from the consumer includes that this event occurred in the united kingdom (previously reported country of incidence was united states) and reaction data (outcome of the events).Follow-up (23jan2014): follow-up attempts completed.No further information expected.Follow-up (16oct2019): new information received from the same contactable consumer includes: reaction data (additional event scar).This case was upgraded to a reportable mdr.Follow-up (12dec2019 and 13dec2019): new information received from product complaints included product investigation summary results.Follow-up attempts are completed.No further information is expected., comment: based on the information provided, the events of blister, device issue and scar as described are considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.The events are 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.There is not a product quality related trend identified for the subclass wrap/patch/pad too hot.No remedial action/corrective action/field safety corrective action is suggested at this time.

Manufacturer Narrative

Conclusion: this investigation was conducted for an unknown lot number lower back/hip (lbh) 8 hour product.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 wrap/patch/pad too hot.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.Based on the complaint narrative, the patient developed red marks on skin as the product was too hot.Review of complaint description concludes there is no device malfunction.Severity of harm reported as s3.

• Brand Name: THERMACARE LOWER BACK & HIP
• Type of Device: DISPOSABLE PACK, HOT
• Manufacturer (Section D): PFIZER CONSUMER HEALTH CARE; 1231 wyandotte drive; albany GA 31705
• MDR Report Key: 9255515
• MDR Text Key: 184333897
• Report Number: 1066015-2019-00251
• 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,foreign
• Type of Report: Initial,Followup
• Report Date: 11/13/2013

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: 10/30/2019
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/24/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention