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

Lot Number X17174

Device Problems Leak/Splash (1354); Product Quality Problem (1506); Fitting Problem (2183)

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

Event Type  malfunction  

Manufacturer Narrative

Conclusion from the product quality complaint group included: confirmation status: not confirmed.Regarding subclass: cells damaged/leaking: additional information received from product quality complaint (pqc) group included investigation results.The root cause category is non-assignable (complaint not confirmed).The complaint of cell pack leak cannot be confirmed; a return sample has not been received at the site for evaluation.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.Regarding device malfunction severity level: the complaint #-us was received under the sub-class "damage/leakage".This is a potential device malfunction s3-skin burn- per rpt- 74091 bridging pfizer hal severity numbers applied in the thermacare heat wrap rmp, effective 28sep2018, version 1.0.Since a sample of the wrap could not be evaluated as part of the investigation process.Regarding sub class: non-defect - product comfort/fit/does not stay in place: introduction: thermacare heat wraps are premium topical heat therapy products.The heat wraps are worn against the body or over a layer of clothing to relieve minor muscular and joint aches and pains.A non- defect complaint represents a suggestion/concern about the existing product that does not include a product quality issue, but is related to a suggestion for improvement.Complaint handling for non-defect subclass: complaints received at the site in the global complaint database related to non-defect will not be investigated in qts.These complaints will be evaluated in the.

Event Description

Event verbatim [preferred term] charcoal started to leak out of the thermacare heatwrap [device leakage].Case narrative: this is a spontaneous report from a contactable consumer reported for herself.A (b)(6) years-old female patient started to receive thermacare heatwrap (thermacare neck, shoulder & wrist), device lot number x17174, expiration date aug2021, upc number (b)(4), from an unspecified date to an unspecified date at unknown frequency for tight muscles in neck.Medical history was none.There were no concomitant medications.The patient mentioned she had used the back ones thermacare heatwrap (thermacare lower back & hip) before for unknown indication, and she didn't have any problems.She stated she called previously and reported she wished the thermacare heatwraps for the back could be made in larger sizes bigger than xl so it could better fit larger people.The patient purchased the thermacare heatwraps for neck pain therapy.She had never worn them before.Her husband had to help reposition the heatwrap a couple of times for comfort.She noticed after taking it off that the charcoal located at the bottom cell was starting to leak out.She could see it through the material.She also stated she couldn't get the heatwrap to fit right.She tried putting on a shirt to hold it closer to her neck, but it started leaking anyhow so she stopped using the product.She wanted to call and report a complaint on this defective product.She could not bring it back to the grocery store for a refund since she already opened the product and used one of the heatwraps.She purchased the three plus one package (4 total).She only used one.The rest of the heatwraps were unopened.She also explained that the picture showed the heatwrap wrapped around the neck and if you looked on the back the heatwrap was laying flat on the shoulders.There was a discrepancy on the advertisement.She mentioned the contouring of the product was not right and the product was not designed very well.The heatwrap did not fit right.However, she positioned it the cells weren't touching.That's why she put it over her shirt, but this still did not help.She used the product in (b)(6) 2018 or the beginning of (b)(6) 2019.She provided number (b)(4).The patient originally wore the heatwrap herself.She later asked her husband to reposition the heatwrap.Packaging was sealed and intact.Device was available for evaluation.There were no seriousness criteria.There was no malfunction.The action taken in response to the event for thermacare heatwrap was permanently withdrawn.The outcome of the event was unknown.The reporter considered that the product leaking was directly related to the thermacare heatwrap itself.Conclusion from the product quality complaint group included: confirmation status: not confirmed.Regarding subclass: cells damaged/leaking: additional information received from product quality complaint (pqc) group included investigation results.The root cause category is non-assignable (complaint not confirmed).The complaint of cell pack leak cannot be confirmed; a return sample has not been received at the site for evaluation.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.Regarding device malfunction severity level: the complaint # us was received under the sub-class "damage/leakage".This is a potential device malfunction s3-skin burn- per rpt- 74091 bridging pfizer hal severity numbers applied in the thermacare heat wrap rmp, effective 28sep2018, version 1.0.Since a sample of the wrap could not be evaluated as part of the investigation process.Regarding sub class: non-defect - product comfort/fit/does not stay in place: introduction: thermacare heat wraps are premium topical heat therapy products.The heat wraps are worn against the body or over a layer of clothing to relieve minor muscular and joint aches and pains.A non- defect complaint represents a suggestion/concern about the existing product that does not include a product quality issue, but is related to a suggestion for improvement.Complaint handling for non-defect subclass: complaints received at the site in the global complaint database related to non-defect will not be investigated in qts.These complaints will be evaluated in the global complaint database to ensure they are due to a non-defect issue.No additional investigation will be required for these complaints based on the following: released batches met specification criteria at the time of release.There is no severity assigned to a non-defect.This document will be attached to the complaint record in the global database and closed with no further action taken.A site investigation was conducted on production records.A device malfunction was not identified during records review.The site investigation has determined there is no further investigation or actions needed.Follow-up (11jan2019): new information received from product quality complaints group included: investigational results.Follow-up (08jan2019): this follow-up report is being submitted as a non-serious, reportable medical device report.Additional information received on 21feb2019, 11mar2019, 19mar2019, and 25mar2019 from product quality complaints includes investigational results.Company clinical evaluation comment: the patient reported the heatwrap and after taking it off the charcoal located at the bottom cell started to leak out.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 suggested at this time., comment: the patient used the heatwrap and after taking it off the charcoal located at the bottom cell started to leak out.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 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
• Manufacturer Contact: stella pietrafesa ; 235 e42nd street; new york, NY 10017
• MDR Report Key: 8479269
• MDR Text Key: 152041451
• Report Number: 1066015-2019-00084
• Device Sequence Number: 1
• Product Code: IMD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K953442
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/03/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 70 YR