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

Lot Number X17174

Device Problems Leak/Splash (1354); Improper or Incorrect Procedure or Method (2017); Material Split, Cut or Torn (4008)

Patient Problem No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

According to the product quality complaint group investigation summary on (b)(6) 2019: lot number is valid as x17174 (initially reported as x17174n).Title / short description: x17174 nsw8 us 3+1ct cells damaged/leaking (expedite), there were no damaged/leaking cells found in the retain inspection.A site investigation was conducted on production records; a device malfunction was not identified during records review.Based on the complaint narrative this represents a potential device malfunction, severity ranking is s3-skin burn per bridging pfizer severity numbers applied in the thermacare heat wrap rmp.A return sample was not received; a device malfunction cannot be confirmed.There is no further investigation or actions needed.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 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] she still used them, but had to pick the metal strips off [intentional device misuse] , product has little cuts and shreds of really, really thin metal on the actual wrap.She still used them, but had to pick the metal strips off.It was like little tears in the wrap too [device leakage].Case narrative:this is a spontaneous report from a contactable consumer (patient).A (b)(6) female patient started to receive thermacare heatwrap (thermacare neck, shoulder & wrist), device lot number x17174, expiration date aug2021, from an unspecified date at an unknown frequency for an unspecified indication.The patient's medical history and concomitant medications were not reported.The patient had a product complaint about thermacare neck pain therapy heatwraps.This was the second one that she had opened that had little cuts and shreds of really, really thin metal on the actual wrap.She still used them on an unspecified date, but had to pick the metal strips off.It was like little tears in the wraps too.The heat wrap was "clearly punctured" and the fabric surface was unusually thin 'the packaging was sealed and intact.The consumer confirmed 2 wraps that had this issue were from the same box.A sample is not available for return at this time.The device was not available for evaluation.Action taken in response to the event was unknown.The clinical outcome of the events was unknown.According to the product quality complaint group investigation summary on (b)(6) 2019 and (b)(6) 2019: lot number is valid as x17174 (initially reported as x17174n).Title / short description: x17174 nsw8 us 3+1ct cells damaged/leaking (expedite), there were no damaged/leaking cells found in the retain inspection.A site investigation was conducted on production records; a device malfunction was not identified during records review.Based on the complaint narrative this represents a potential device malfunction, severity ranking is s3-skin burn per bridging pfizer severity numbers applied in the thermacare heat wrap rmp.A return sample was not received; a device malfunction cannot be confirmed.There is no further investigation or actions needed.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 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.Company clinical evaluation comment: based on the available information, the patient identified that the heatwrap "has little cuts and shreds of really, really thin metal on the actual wrap" and "she still used them, but had to pick the metal strips off.It was like little tears in the wrap too".There was "no adverse reaction" 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 remedial action/corrective action/field safety corrective action is suggested at this time., comment: based on the available information, the patient identified that the heatwrap "has little cuts and shreds of really, really thin metal on the actual wrap" and "she still used them, but had to pick the metal strips off.It was like little tears in the wrap too".There was "no adverse reaction" 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 remedial action/corrective action/field safety corrective action is suggested at this time.

Event Description

Event verbatim [preferred term] product has little cuts and shreds of really, really thin metal on the actual wrap.She still used them, but had to pick the metal strips off.It was like little tears in the wrap too [device leakage] , she still used them, but had to pick the metal strips off [intentional device misuse] , reason for taking: lbp [device use issue] ,.Case narrative:this is a spontaneous report from a contactable consumer (patient).A 60-year-old female patient started to receive thermacare heatwrap (thermacare neck, shoulder & wrist), device lot number x17174, expiration date aug2021, from an unspecified date during jan - feb2019 at an unknown frequency for lbp (lower back pain).The patient's medical history was not reported.There were no concomitant medications.The patient had a product complaint about thermacare neck pain therapy heatwraps.This was the second one that she had opened that had little cuts and shreds of really, really thin metal on the actual wrap.She still used them on an unspecified date during jan - feb2019, but had to pick the metal strips off.It was like little tears in the wraps too.The heat wrap was "clearly punctured" and the fabric surface was unusually thin 'the packaging was sealed and intact.The consumer confirmed 2 wraps that had this issue were from the same box.A sample is not available for return at this time.The device was not available for evaluation.Action taken in response to the event was discontinued.The patient was not admitted to hospital and did not receive any treatment for event "product has little cuts and shreds of really, really thin metal on the actual wrap.She still used them, but had to pick the metal strips off.It was like little tears in the wrap too".The clinical outcome of the events was unknown.According to the product quality complaint group investigation summary on 02apr2019 and 04apr2019: lot number is valid as x17174 (initially reported as x17174n).Title / short description: x17174 nsw8 us 3+1ct cells damaged/leaking (expedite), there were no damaged/leaking cells found in the retain inspection.A site investigation was conducted on production records; a device malfunction was not identified during records review.Based on the complaint narrative this represents a potential device malfunction, severity ranking is s3-skin burn per bridging pfizer severity numbers applied in the thermacare heat wrap rmp.A return sample was not received; a device malfunction cannot be confirmed.There is no further investigation or actions needed.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 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 (04jun2019): new information received from a contactable consumer included: suspect product details (including start date updated to during jan - feb2019, indication update to lbp), no concomitant medications, reaction data (including event onset date updated to during jan - feb2019, new event "reason for taking: lbp" added, deny of hospitalization and treatment), action taken updated to discontinued.Follow-up attempts are completed.No further information is expected.Company clinical evaluation comment: based on the available information, the patient identified that the heatwrap "has little cuts and shreds of really, really thin metal on the actual wrap" and "she still used them, but had to pick the metal strips off.It was like little tears in the wrap too".There was "no adverse reaction" 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 remedial action/corrective action/field safety corrective action is suggested at this time., comment: based on the available information, the patient identified that the heatwrap "has little cuts and shreds of really, really thin metal on the actual wrap" and "she still used them, but had to pick the metal strips off.It was like little tears in the wrap too".There was "no adverse reaction" 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 remedial action/corrective action/field safety corrective action is suggested at this time.

Manufacturer Narrative

According to the product quality complaint group investigation summary on (b)(6) 2019 and (b)(6) 2019: lot number is valid as x17174 (initially reported as x17174n).Title / short description: x17174 nsw8 us 3+1ct cells damaged/leaking (expedite), there were no damaged/leaking cells found in the retain inspection.A site investigation was conducted on production records; a device malfunction was not identified during records review.Based on the complaint narrative this represents a potential device malfunction, severity ranking is s3-skin burn per bridging pfizer severity numbers applied in the thermacare heat wrap rmp.A return sample was not received; a device malfunction cannot be confirmed.There is no further investigation or actions needed.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 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.

• 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: 8508632
• MDR Text Key: 152525923
• Report Number: 1066015-2019-00095
• 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: 04/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/01/2021
• Device Lot Number: X17174
• Was Device Available for Evaluation?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 60 YR