MAUDE Adverse Event Report: PFIZER CONSUMER HEALTH CARE ROBAX LOWER BACK & HIP HEATWRAP; DISPOSABLE PACK, HOT

Catalog Number 062107336307

Device Problems Break (1069); Gel Leak (1267)

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).Without the alleged defective sample 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

Found black liquid on two heatwraps.Liquid look like a grease, on one side of the pad.He did not use this specific product [device leakage].Case narrative:this is a spontaneous report from a contactable consumer.A male patient of an unspecified age started to receive thermacare heatwrap (robax lower back & hip heatwrap), device lot number m29978, expiration date 31aug2018, on an unspecified date, for an unspecified indication.Medical history and concomitant medications were not reported.The patient stated that he was an experienced user of the product.He reported that he found black liquid on two heatwraps and on the belt connection.The liquid looked like grease, on one side of the pad.In addition, he said it looked like the pads leaked.He has never experienced this but he did not use this specific heatwrap.The action taken with thermacare heatwrap and the outcome of the event was not reported.The product quality group reported that: the root cause category is non-assignable (complaint not confirmed).Without the alleged defective sample 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.Additional information has been requested and will be provided as it becomes available.Company clinical evaluation comment: based on the available information, the patient "found black liquid on two heatwraps and on the belt." 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 "found black liquid on two heatwraps and on the belt." 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).Without the alleged defective sample 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] found black liquid on two heatwraps.Liquid look like a grease, on one side of the pad.He did not use this specific product [device leakage].Case narrative:this is a spontaneous report from a contactable consumer.A male patient of an unspecified age started to receive thermacare heatwrap (robax lower back & hip heatwrap), device lot number m29978, expiration date 31aug2018, on an unspecified date, for an unspecified indication.Medical history and concomitant medications were not reported.The patient stated that he was an experienced user of the product.He reported that he found black liquid on two heatwraps and on the belt connection.The liquid looked like grease, on one side of the pad.In addition, he said it looked like the pads leaked.He has never experienced this but he did not use this specific heatwrap.The action taken with thermacare heatwrap and the outcome of the event was not reported.The product quality group reported that: the root cause category is non-assignable (complaint not confirmed).Without the alleged defective sample 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.Additional information has been requested and will be provided as it becomes available.Company clinical evaluation comment: based on the available information, the patient "found black liquid on two heatwraps and on the belt." 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.Follow-up (23dec2019): this follow-up is being submitted to notify that an investigation of the device is ongoing, comment: based on the available information, the patient "found black liquid on two heatwraps and on the belt." 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).Without the alleged defective sample 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] found black liquid on two heatwraps.Liquid look like a grease, on one side of the pad.He did not use this specific product [device leakage] ,.Case narrative:this is a spontaneous report from a contactable consumer.A male patient of an unspecified age started to receive thermacare heatwrap (robax lower back & hip heatwrap), device lot number m29978, expiration date 31aug2018, catalog #062107336307, on an unspecified date, for an unspecified indication.Medical history and concomitant medications were not reported.The patient stated that he was an experienced user of the product.He reported that he found black liquid on two heatwraps and on the belt connection.The liquid looked like grease, on one side of the pad.In addition, he said it looked like the pads leaked.He has never experienced this but he did not use this specific heatwrap.The action taken with thermacare heatwrap and the outcome of the event was not reported.The product quality group reported that: the root cause category is non-assignable (complaint not confirmed).Without the alleged defective sample 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.Follow-up (23dec2019): this follow-up is being submitted to notify that an investigation of the device is ongoing.Follow-up (19feb2020): this follow-up report is being submitted as a final reportable mdr., comment: based on the available information, the patient "found black liquid on two heatwraps and on the belt." 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.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: ROBAX LOWER BACK & HIP HEATWRAP
• Type of Device: DISPOSABLE PACK, HOT
• Manufacturer (Section D): PFIZER CONSUMER HEALTH CARE; 1231 wyandotte drive; albany GA 31705
• MDR Report Key: 9263333
• MDR Text Key: 220012270
• Report Number: 1066015-2019-00447
• 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,Followup
• Report Date: 04/26/2017

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: 08/31/2018
• Device Catalogue Number: 062107336307
• Device Lot Number: M29978
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/31/2019
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 12/26/2019; 03/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1