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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Skin Irritation (2076)

Event Date 01/01/2017

Event Type  Injury  

Event Description

Event verbatim [preferred term] removed my skin [skin exfoliation] ,.Case narrative:this is a spontaneous report from a pfizer-sponsored program thermacare (b)(6) page from a contactable consumer.A patient of unspecified age ethnicity and gender started to receive thermacare heatwrap (thermacare heatwrap) via an unspecified route of administration from an unspecified date for an unspecified indication.The patient medical history was not reported.The patient's concomitant medications were not reported.The patient stated that "they help me and i've used them for years.About a month ago, however, i used one on my lower back and upon removal the adhesive actually removed skin." event outcome was unknown.No follow-up attempts are possible.No further information is expected.Follow-up (17feb2017): 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 "upon removal the adhesive actually removed skin" 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 events of "upon removal the adhesive actually removed skin" 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

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 adverse event safety request for investigation.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: a lot trend was not performed as the lot number is unknown.Site sample status has not been received.

Event Description

Event verbatim [preferred term] removed skin [skin exfoliation].Case narrative:this is a spontaneous report from the pfizer-sponsored program thermacare facebook page from a contactable consumer (patient).A patient of unknown age and gender started to receive thermacare heatwrap (thermacare heatwrap) on an unknown date for years for an unknown indication.Relevant medical history and concomitant medications were not provided.The patient stated they helped him/her and he/she used them for years.About a month before the report time (in jan2017), however, the patient used one on his/her lower back and upon removal the adhesive actually removed skin.The action taken with thermacare heatwrap in response to the event and the clinical outcome of the event were unknown at the time of the report.The product quality complaint group provided the following investigation results.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 adverse event safety request for investigation.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: a lot trend was not performed as the lot number is unknown.Site sample status has not been received.No follow-up attempts are possible.No further information is expected.Follow-up (17feb2017): this follow-up report is being submitted to upgrade this case to a reportable mdr.Follow-up (19mar2020): new information from the product quality complaint group included: investigation results.Follow-up attempts are completed.No further information is expected., comment: based on the information provided, the event of "upon removal the adhesive actually removed skin" 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.There is not a product quality related trend identified for the subclass adverse event safety request for investigation.No further investigations or actions is suggested at this time.

• 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: 9257503
• MDR Text Key: 179978779
• Report Number: 1066015-2019-00293
• 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
• Report Date: 02/17/2017

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?: No
• 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: 04/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention