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

Lot Number N22187

Device Problems Break (1069); Leak/Splash (1354); Component Missing (2306); Defective Device (2588)

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).The alleged defective sample is not available for evaluation by the site.Without the defective wrap for evaluation, the complaint cannot 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.

Event Description

Event verbatim [preferred term] 3 heat wraps had defective heat cells, in 1 the heat cell was torn, but the content stayed inside, and 2 had no glue [device leakage].Case narrative: this is a spontaneous report from a contactable consumer.A female patient of an unspecified age started to receive thermacare heatwrap (thermacare neck, shoulder & wrist), device lot number n22187, expiration date dec2018, from an unspecified date for an unspecified indication.The patient's medical history and concomitant medications were not reported.The patient stated 3 heat wraps had defective heat cells, in 1 the heat cell was torn, but the content stayed inside, and 2 had no glue on an unspecified date.The action taken with thermacare heatwrap was unknown.The outcome of the event was unknown.Product investigation results received on 06dec2016 were as follows: the root cause category is non assignable (complaint not confirmed).The alleged defective sample is not available for evaluation by the site.Without the defective wrap for evaluation, the complaint cannot 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.No follow-up attempts are needed.No further information is expected.Company clinical evaluation comment: based on the available information, the patient reported "heat wraps had defective heat cells, in 1 the heat cell was torn, but the content stayed inside, and 2 had no glue." no 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 review of the lot/batch records does not suggest a defect or quality issue related to the manufacture of this lot.No device malfunction has been identified.No further investigations or actions is suggested at this time.Comment: based on the available information, the patient reported "heat wraps had defective heat cells, in 1 the heat cell was torn, but the content stayed inside, and 2 had no glue." no 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 review of the lot/batch records does not suggest a defect or quality issue related to the manufacture of this lot.No device malfunction has been identified.No further investigations or actions is suggested at this time.

Manufacturer Narrative

The root cause category is non assignable (complaint not confirmed).The alleged defective sample is not available for evaluation by the site.Without the defective wrap for evaluation, the complaint cannot 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.

Event Description

Event verbatim [preferred term] 3 heat wraps had defective heat cells, in 1 the heat cell was torn, but the content stayed inside, and 2 had no glue [device leakage].Case narrative:this is a spontaneous report from a contactable consumer.A female patient of an unspecified age started to receive thermacare heatwrap (thermacare neck, shoulder & wrist), device lot number n22187, expiration date dec2018, from an unspecified date for an unspecified indication.The patient's medical history and concomitant medications were not reported.The patient stated 3 heat wraps had defective heat cells, in 1 the heat cell was torn, but the content stayed inside, and 2 had no glue on an unspecified date.The action taken with thermacare heatwrap was unknown.The outcome of the event was unknown.Product investigation results received on 06dec2016 were as follows: the root cause category is non assignable (complaint not confirmed).The alleged defective sample is not available for evaluation by the site.Without the defective wrap for evaluation, the complaint cannot 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.No follow-up attempts are needed.No further information is expected.Follow-up (16dec2019): this follow-up report is being submitted as a final reportable mdr., comment: based on the available information, the patient reported "heat wraps had defective heat cells, in 1 the heat cell was torn, but the content stayed inside, and 2 had no glue." no 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 review of the lot/batch records does not suggest a defect or quality issue related to the manufacture of this lot.No device malfunction has been identified.No device malfunction has been identified.No remedial action/corrective action/field safety corrective action 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: 9263332
• MDR Text Key: 219952990
• Report Number: 1066015-2019-00424
• 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: 12/01/2016

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: 12/01/2018
• Device Lot Number: N22187
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/31/2019
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1