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 Problems Tissue Damage (2104); Skin Tears (2516)

Event Type  Injury  

Event Description

Event verbatim [preferred term] surface of skin peeled off when removing the heat wrap [skin exfoliation] ,.Case narrative:this is a spontaneous report from a pfizer-sponsored program, brand websites for division consumer healthcare (b)(6).A contactable consumer reported that a female patient of an unspecified age started to use thermacare heatwrap (thermacare heatwrap) via an unspecified route from an unspecified date at an unspecified frequency for an unspecified indication.The patient medical history and concomitant medications were not reported.The patient had been using the thermacare products many times and had made her life easier because she could move again.Last time she used a heat wrap, however, her experience was quite unfavorable: when she was wearing the heat wrap, she felt a tearing in one place and when she removed the heat wrap, the surface of the skin came off with the heat wrap.The action taken in response to the event for thermacare heatwrap was unknown.The outcome of the event was unknown.Additional information has been requested and will be provided as it becomes available.Follow-up (12apr2017): follow-up attempts completed.No further information expected.Follow-up (08feb2017): 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 event skin exfoliation 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 skin exfoliation 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

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/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.

Event Description

Surface of skin peeled off when removing the heat wrap [skin exfoliation].Case narrative: this is a spontaneous report from a pfizer-sponsored program, brand websites for devision consumer healthcare germany.A contactable consumer reported that a female patient of an unspecified age started to use thermacare heatwrap (thermacare heatwrap) via an unspecified route from an unspecified date at an unspecified frequency for an unspecified indication.The patient medical history and concomitant medications were not reported.The patient had been using the thermacare products many times and had made her life easier because she could move again.Last time she used a heat wrap, however, her experience was quite unfavorable: when she was wearing the heat wrap, she felt a tearing in one place and when she removed the heat wrap, the surface of the skin came off with the heat wrap.The action taken in response to the event for thermacare heatwrap was unknown.The outcome of the event was unknown.According to product quality complaint group, 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/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.Follow-up (12apr2017): follow-up attempts completed.No further information expected.Follow-up (08feb2017): this follow-up report is being submitted to upgrade this case to a reportable mdr.Follow-up (22nov2019): this follow-up report was received from product quality complaint group includes investigational results.This follow-up report is also being submitted to amend previously reported information: it was not reported whether or not the reporter sent report to fda.No follow-up attempts needed.No further information expected., comment: based on the information provided, the event skin exfoliation 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 trend identified.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: 9257505
• MDR Text Key: 180821987
• Report Number: 1066015-2019-00292
• 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: 02/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event 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: 12/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention