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

Lot Number W24915

Device Problem Leak/Splash (1354)

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

Event Type  malfunction  

Event Description

One of the three thremacares was not adhering to itself and reveal the grey, putty like substance [device leakage].Case narrative: this is a spontaneous report from a contactable consumer.This male patient of unspecified age started to receive thermacare heatwraps (thermacare neck/wrist/shoulder) for pain management.Lot number and expiration date were unknown.Relevant medical history and concomitant medications were not reported.The consumer opened the pack and one of the three thermacare was not adhering to itself and reveal the grey, putty like substance.The action taken with thermacare and outcome of the event were not provided.Additional information has been requested and will be provided as it becomes available.Company clinical evaluation comment : the patient reported that one of the three thremacares was not adhering to itself and reveal the grey, putty like substance.The single event device leakage is medically assessed as associated with the use of the device and is non-serious.No other adverse event such as burn was associated with the use of the device.This is a single potential device malfunction which has a theoretical risk to cause skin burn.The company is conducting further review on this investigation and additional follow-up will be reported when the evaluation is completed.Comment: the patient reported that one of the three thremacares was not adhering to itself and reveal the grey, putty like substance.The single event device leakage is medically assessed as associated with the use of the device and is non-serious.No other adverse event such as burn was associated with the use of the device.This is a single potential device malfunction which has a theoretical risk to cause skin burn.The company is conducting further review on this investigation and additional follow-up will be reported when the evaluation is completed.

Event Description

Event verbatim [preferred term] one of the three thremacares was not adhering to itself and reveal the grey, putty like substance [device leakage].Case narrative:this is a spontaneous report from a contactable consumer.This male patient of unspecified age started to receive thermacare heatwraps (thermacare neck/wrist/shoulder) for pain management.Lot number and expiration date were unknown.Relevant medical history and concomitant medications were not reported.The consumer opened the pack and one of the three thermacare was not adhering to itself and reveal the grey, putty like substance.The action taken with thermacare and outcome of the event were not provided.The consumer provided pictures of the product.Product quality complaints provided severity of harm rating of s3 and assessed there was reasonable suggestion of device malfunction.Final confirmation status was not confirmed.Additional information has been requested and will be provided as it becomes available.Follow-up (08dec2019, 09dec2019, and 10dec2019): new information from product quality complaints and from a contactable consumer includes: severity of harm (s3), malfunction assessment (yes), confirmation status (not confirmed), and photos were provided by the consumer.Company clinical evaluation comment: the patient reported that one of the three thremacares was not adhering to itself and reveal the grey, putty like substance.The single event device leakage is medically assessed as associated with the use of the device and is non-serious.No other adverse event such as burn was associated with the use of the device.This is a single potential device malfunction which has a theoretical risk to cause skin burn.The company is conducting further review on this investigation and additional follow-up will be reported when the evaluation is completed., comment: the patient reported that one of the three thremacares was not adhering to itself and reveal the grey, putty like substance.The single event device leakage is medically assessed as associated with the use of the device and is non-serious.No other adverse event such as burn was associated with the use of the device.This is a single potential device malfunction which has a theoretical risk to cause skin burn.The company is conducting further review on this investigation and additional follow-up will be reported when the evaluation is completed.

Event Description

Event verbatim [preferred term] one of the three thremacares was not adhering to itself and reveal the grey, putty like substance [device leakage] ,.Case narrative:this is a spontaneous report from a contactable consumer.This 43-year-old female patient started to receive thermacare heatwraps (thermacare neck/wrist/shoulder), lot # w24915, expiry mar2021, in (b)(6) 2019 for pain management/ neck pain.Relevant medical history and concomitant medications were not reported.During (b)(6) 2019, the consumer opened the pack and one of the three thermacare was not adhering to itself and reveal the grey, putty like substance.She discovered the adhesive on gauze to be missing, exposing the grey heating elements.She did not use the product as it was unsafe.The action taken with thermacare was temporarily withdrawn.There was no hospitalization for the event and no treatment was received.The outcome of the event was recovered on an unspecified date.The consumer provided pictures of the product.Product quality complaints provided severity of harm rating of s3 and assessed there was reasonable suggestion of device malfunction.Final confirmation status was not confirmed.A return sample has not been received at the site for evaluation as of 31dec2019.This investigation was conducted for an unknown lot number neck/shoulder/wrist (nsw) 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 adhesion/fastening defect.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 (08dec2019, 09dec2019, and 10dec2019): new information from product quality complaints and from a contactable consumer includes: severity of harm (s3), malfunction assessment (yes), confirmation status (not confirmed), and photos were provided by the consumer.Follow-up (10jan2020 and 14jan2020): new information received from product quality complaint group includes investigation results; and from a contactable consumer includes patient information (age, weight, and gender updated from male to female), product information (start date, updated indication, lot and expiry, action taken), event information (additional description, start date, hospitalization information, treatment information, and outcome).Follow-up attempts are completed.No further information is expected.Company clinical evaluation comment": the patient reported that one of the three thremacares was not adhering to itself and reveal the grey, putty like substance.The single event device leakage is medically assessed as associated with the use of the device and is non-serious.No other adverse event such as burn was associated with the use of the device.This is a single potential device malfunction which has a theoretical risk to cause skin burn.The review of the lot/batch records does not suggest a defect or quality issue related to the manufacture of this lot.There is not a product quality related trend identified.No further investigations or actions is suggested at this time., comment: the patient reported that one of the three thremacares was not adhering to itself and reveal the grey, putty like substance.The single event device leakage is medically assessed as associated with the use of the device and is non-serious.No other adverse event such as burn was associated with the use of the device.This is a single potential device malfunction which has a theoretical risk to cause skin burn.The review of the lot/batch records does not suggest a defect or quality issue related to the manufacture of this lot.There is not a product quality related trend identified.No further investigations or actions is suggested at this time.

• 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: 9444823
• MDR Text Key: 220532120
• Report Number: 1066015-2019-00534
• 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,Followup
• Report Date: 11/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/01/2021
• Device Lot Number: W24915
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/10/2019
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 12/17/2019; 02/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 43 YR
• Patient Weight: 50