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

Lot Number X41714

Device Problems Break (1069); Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

Event verbatim [preferred term] sachets opened [device leakage] ,.Case narrative:this is a spontaneous report from a contactable pharmacist.A patient of unspecified age and gender started to receive thermacare heatwrap (thermacare neck, shoulder & wrist), device lot number x41714, expiration date 31oct2021, from an unspecified date for an unspecified indication.The patient's medical history and concomitant medications were not reported.The patient stated sachets opened on an unspecified date.The action taken with thermacare heatwrap is unknown.The outcome of the event was unknown.The complaint sub-class was reported as container broken/cracked/leaking prior to use.The initial review and rationale is in progress, investigation is pending.Additional information has been requested and will be provided as it becomes available.Company clinical evaluation comment the event "satchets opened" (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 which has a theoretical risk to cause skin burn.The event was assessed as associated with the use of the device., comment: the event "satchets opened" (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 which 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] sachets opened [device leakage].Case narrative:this is a spontaneous report from contactable pharmacists.A patient of unspecified age and gender started to receive thermacare heatwrap (thermacare neck, shoulder & wrist), device lot number x41714, expiration date 31oct2021, from an unspecified date for an unspecified indication.The patient's medical history and concomitant medications were not reported.The patient stated sachets opened on an unspecified date.The other reporting pharmacist confirmed that there was a patient involved but that no other information was currently available since the person who first reported the notification was not at the pharmacy.The action taken with thermacare heatwrap is unknown.The outcome of the event was unknown.According to product quality complaint group, reasonably suggest device malfunction: yes.Severity of harm: s3.Additional information has been requested and will be provided as it becomes available.Follow-up (06nov2019 and 07nov2019): new information received from product quality complaint group and another contactable pharmacist included: malfunction assessment, severity of harm and additional reporter.Company clinical evaluation comment: the event "satchets opened" (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 which has a theoretical risk to cause skin burn.The event was assessed as associated with the use of the device., comment: the event "satchets opened" (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 which has a theoretical risk to cause skin burn.The event was 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).A return sample is not available at the site for evaluation; the complaint can not be 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 quality issues were identified upon this review of the batch device history record, in process attributes and variable quality checks or, inspection of retained samples.Retained samples met the product description and the product is within expiration date.The product quality for the batch is not impacted by this complaint.

Event Description

Event verbatim [preferred term] sachets opened [device leakage] ,.Case narrative:this is a spontaneous report from contactable pharmacists.A patient of unspecified age and gender started to receive thermacare heatwrap (thermacare neck, shoulder & wrist), device lot number x41714, expiration date (b)(6) 2021, from an unspecified date for an unspecified indication.The patient's medical history and concomitant medications were not reported.The patient stated that the sachets opened on an unspecified date.The other reporting pharmacist confirmed that there was a patient involved but that no other information was currently available since the person who first reported the notification was not at the pharmacy.The action taken with thermacare heatwrap is unknown.The outcome of the event was unknown.According to product quality complaint group, reasonably suggest device malfunction: yes.Severity of harm: s3.The root cause category is non assignable (complaint not confirmed as a quality defect).A return sample is not available at the site for evaluation; the complaint can not be 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 quality issues were identified upon this review of the batch device history record, in process attributes and variable quality checks or, inspection of retained samples.Retained samples met the product description and the product is within expiration date.The product quality for the batch is not impacted by this complaint.Follow-up ((b)(6) 2019 and (b)(6) 2019): new information received from product quality complaint group and another contactable pharmacist included: malfunction assessment, severity of harm and additional reporter.Follow-up ((b)(6) 2019): new information received from product quality group includes: investigation summary.Follow-up attempts are completed.No further information is expected., comment: the complaint of "satchets opened" (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 which has a theoretical risk to cause skin burn.A causal relationship between the device and the device complaint cannot be ruled out.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 complaint trend for any class(es) associated to the suggested key product complaints database terms.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: 9306096
• MDR Text Key: 220024068
• Report Number: 1066015-2019-00472
• 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: foreign,health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 10/29/2019

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: 10/31/2021
• Device Lot Number: X41714
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/11/2019
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 11/15/2019; 02/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1