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

Device Problem Leak/Splash (1354)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

The root cause category is non-assignable (complaint not confirmed).Our 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.No trend has been identified for lbh product for the subclass of cells damaged/leaking.Further investigation req'd: no.

Event Description

Event verbatim [preferred term] one of the heat cells had leaked out.[device leakage] ,.Case narrative:this is a spontaneous report from a contactable consumer.A patient of unknown age and gender started to receive thermacare heatwrap (thermacare neck, shoulder & wrist) from unknown date at unknown frequency for unknown indication.Medical history and concomitant medications were not reported.The patient went to use heat wrap and one of the heat cells had leaked out.The action taken in response to the event of the product 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).Our 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.No trend has been identified for lbh product for the subclass of cells damaged/leaking.Further investigation req'd: no.Follow-up (28jan2019): this follow-up report is being submitted to upgrade this case to a reportable mdr.Company clinical evaluation comment the event "one of the heat cells had leaked out" (device leakage) was assessed as non-serious.No other adverse event was associated with the use of the device.This is a single potential device malfunction has a theoretical risk to cause skin burn.The event was assessed as associated with the use of the device., comment: the event "one of the heat cells had leaked out" (device leakage) was assessed as non-serious.No other adverse event was associated with the use of the device.This is a single potential device malfunction has a theoretical risk to cause skin burn.The event was assessed as associated with the use of the device.

Event Description

Event verbatim [preferred term] one of the heat cells had leaked out.[device leakage].Case narrative:this is a spontaneous report from a contactable consumer.A patient of unknown age and gender started to use thermacare heatwrap (thermacare neck, shoulder & wrist) from unknown date at an unknown frequency for an unknown indication.Medical history and concomitant medications were not reported.The patient went to use heat wrap and one of the heat cells had leaked out.The action taken in response to the event of the product 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).Our 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.No trend has been identified for lbh product for the subclass of cells damaged/leaking.Further investigation required: no.On (b)(6) 2019, a notification received that the severity of harm has been selected by the manufacturing site as s3.Sterile product: no.Samples available: no.Sample status: not available.Site sample status: not received.Repeat investigation: no.Was capa previously identified: no.Full investigation required: no.Regulatory impact: no.Final confirmation status: not confirmed.Product quality impact: no.Market / clinical impact: no.Stability impact: no.Reserve sample evaluation required: no.Confirmed reserve defect: no.Summary of investigation and conclusion: based on the complaint narrative, the patient experienced heat cell leakage with product use.There was no harm or injury reported.Review of complaint description concludes there is a device malfunction.Follow-up (28jan2019): this follow-up report is being submitted to upgrade this case to a reportable mdr.Follow-up (22oct2019, 23oct2019): new information received from a product quality complaint group includes: malfunction confirmed, severity of harm, summary of investigation and conclusion, and other investigation findings.Company clinical evaluation comment: the event "one of the heat cells had leaked out" (device leakage) was assessed as non-serious.No other adverse event was associated with the use of the device.This is a single potential device malfunction has a theoretical risk to cause skin burn.The event was assessed as associated with the use of the device.The root cause category is non-assignable (complaint not confirmed).No trend has been identified for lbh product for the subclass of cells damaged/leaking.Based on the complaint narrative, the patient experienced heat cell leakage with product use.There was no harm or injury reported.No further investigations or actions are suggested at this time., comment: the event "one of the heat cells had leaked out" (device leakage) was assessed as non-serious.No other adverse event was associated with the use of the device.This is a single potential device malfunction has a theoretical risk to cause skin burn.The event was assessed as associated with the use of the device.The root cause category is non-assignable (complaint not confirmed).No trend has been identified for lbh product for the subclass of cells damaged/leaking.Based on the complaint narrative, the patient experienced heat cell leakage with product use.There was no harm or injury reported.No further investigations or actions are suggested at this time.

Manufacturer Narrative

The root cause category is non-assignable (complaint not confirmed).Our 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.No trend has been identified for lbh product for the subclass of cells damaged/leaking.Further investigation required: no.On (b)(6) 2019, a notification received that the severity of harm has been selected by the manufacturing site as s3.Sterile product: no.Samples available: no.Sample status: not available.Site sample status: not received.Repeat investigation: no.Was capa previously identified: no.Full investigation required: no.Regulatory impact: no.Final confirmation status: not confirmed.Product quality impact: no.Market / clinical impact: no.Stability impact: no.Reserve sample evaluation required: no.Confirmed reserve defect: no.Summary of investigation and conclusion: based on the complaint narrative, the patient experienced heat cell leakage with product use.There was no harm or injury reported.Review of complaint description concludes there is a device malfunction.

• 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: 9261085
• MDR Text Key: 220261622
• Report Number: 1066015-2019-00330
• 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: 01/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/31/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1