MAUDE Adverse Event Report: PFIZER CONSUMER HEALTH CARE THERMACARE NECK, SHOULDER & WRIST; DISPOSABLE PACK, HOT

Device Problems Overheating of Device (1437); Device Operates Differently Than Expected (2913)

Patient Problem Partial thickness (Second Degree) Burn (2694)

Event Date 12/15/2016

Event Type  Injury  

Event Description

Burn blister [burns second degree] ,.Case narrative:this is a spontaneous report from a contactable consumer via a sales representative.A female patient of an unspecified age and ethnicity started to receive thermacare heatwrap (thermacare neck, shoulder & wrist) via an unspecified route of administration from an unspecified date at 1 dose form, unknown frequency for an unspecified indication.The patient medical history was not reported.The patient's concomitant medications were not reported.The patient developed burn blister from using thermacare heat wrap for the neck on (b)(6) 2016.The heat wrap continued to be hot even after 10 hours.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.Company clinical evaluation comment based on the information provided, the event burn blister as described in this case is considered serious bodily injuries potentially requiring medical intervention to prevent permanent damage or impairment of body structure, assessed as associated with the use of the device., comment: based on the information provided, the event burn blister as described in this case is considered serious bodily injuries potentially requiring medical intervention to prevent permanent damage or impairment of body structure, assessed as associated with the use of the device.

Event Description

Event verbatim [preferred term] burn blister [burns second degree] , the heatwrap continued to be hot even after 10 hours [device issue] ,.Case narrative:this is a spontaneous report from a contactable consumer via a sales representative.A female patient of an unspecified age started to receive thermacare heatwrap (thermacare neck, shoulder & wrist) from an unspecified date at 1 dose form, unknown frequency for an unspecified indication.The patient's medical history and concomitant medications were not reported.The patient developed burn blister from using thermacare heatwrap for the neck on (b)(6) 2016.The heatwrap continued to be hot even after 10 hours.Action taken in response to the event for thermacare heatwrap was unknown.The outcome of the event was unknown.Additional information received from product quality complaint (pqc) group included investigation results.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.Follow-up ( (b)(6) 2017): follow-up attempts completed.No further information expected.Case closed.Follow-up ((b)(6) 2020): new information received from product quality complaints (pqc) group included: product quality investigation results and additional event of device issue., comment: based on the information provided, the event burn blister as described in this case is considered serious bodily injuries potentially requiring medical intervention to prevent permanent damage or impairment of body structure, 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

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.

• Brand Name: THERMACARE NECK, SHOULDER & WRIST
• Type of Device: DISPOSABLE PACK, HOT
• Manufacturer (Section D): PFIZER CONSUMER HEALTH CARE; 1231 wyandotte drive; albany GA 31705
• MDR Report Key: 6193004
• MDR Text Key: 62958351
• Report Number: 1066015-2016-00167
• 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: company representative,consum
• Type of Report: Initial,Followup
• Report Date: 12/15/2016

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: 12/21/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention