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

Lot Number W61097

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

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

Event Type  malfunction  

Manufacturer Narrative

The pfizer global complaint database search was performed: scope: date 01apr2016 to 30apr2019, (manufacturing site redacted), complaint class: wrap/patch/pad, sub class: cells damaged/leaking.The search returned a total of 13 complaints for neck shoulder wrist 8 hr.There was 1 complaint confirmed to have a manufacturing process root cause for a complaint of cells damaged/leaking.(b)(4) had a root cause classified as equipment/equipment design.Capa for this investigation are as follows: pr# (b)(4) - modify the logic of the brine system to shutdown the line when the dosing brine arm proximity switch is damage, closed 25mar2015.The complaints were evaluated for potential trend.The calculated complaints per million produced result of 137 was above the upper control limit of 14 per sop-105746 "complaint trending guideline", effective 05feb2019.An evaluation of the 36 month trend chart did not show a significant increase over time.No batch number is available; therefore, there is limited information provided to relate this event with the confirmed complaint.Based on this pcom search for the subclass of cells damaged for nsw8 the data did not show an increase over time.There is not a trend identified for the subclass cells damaged/leaking for nsw8.There is no further action required.Summary: a notification to dsu was sent on 05/02/19 for dmr evaluation attached notification to safety (b)(6).A site investigation was conducted; a device malfunction was not identified during trend review.The complaint narrative represents a potential device malfunction.The severity level is s3 per (b)(4) "bridging pfizer hal severity ranking to severity numbers applied in the thermacare heat wrap rmp", version 1.0, 28sep2018.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).

Event Description

Some wraps which could not use any more because they are leaked [device leakage].Case narrative:the initial case was missing the following minimum criteria: an adverse event with a device.Upon receipt of follow-up information on 02may2019 this case now contains all required information to be considered valid.This is a spontaneous report from a contactable consumer (patient).A patient of unspecified age and gender started to receive thermacare heatwrap (thermacare neck shoulder wrist 8 hour) (lot/batch number: w61097, expiry: may2021) from an unspecified date for an unspecified indication.The patient's medical history and concomitant medications were not reported.On an unspecified date, the patient had a bad experience that there were some wraps which could not use anymore because they had leaked with the plastic package not the box.The patient advised there was a quality issue with the product.The patient reported this might be caused by packing machines and advised to check more about the machine in case of greater loss.The patient wanted to change their product by free returns.It was unknown whether the patient suffered an adverse event as a result of the event.The action taken in response to the event and the outcome of the event were unknown.On 03may2019, pfizer product complaint group provided investigational report: the pfizer global complaint database search was performed: scope: date 01apr2016 to 30apr2019, (manufacturing site redacted), complaint class: wrap/patch/pad, sub class: cells damaged/leaking.The search returned a total of 13 complaints for neck shoulder wrist 8 hr.There was 1 complaint confirmed to have a manufacturing process root cause for a complaint of cells damaged/leaking.(b)(4) had a root cause classified as equipment/equipment design.Capa for this investigation are as follows: pr# (b)(4) - modify the logic of the brine system to shutdown the line when the dosing brine arm proximity switch is damage, closed 25mar2015.The complaints were evaluated for potential trend.The calculated complaints per million produced result of 137 was above the upper control limit of 14 per sop-105746 "complaint trending guideline", effective 05feb2019.An evaluation of the 36 month trend chart did not show a significant increase over time.No batch number is available; therefore, there is limited information provided to relate this event with the confirmed complaint.Based on this search for the subclass of cells damaged for nsw8 the data did not show an increase over time.There is not a trend identified for the subclass cells damaged/leaking for nsw8.There is no further action required.Summary: a notification to dsu was sent on 05/02/19 for dmr evaluation attached notification to safety (b)(4).A site investigation was conducted; a device malfunction was not identified during trend review.The complaint narrative represents a potential device malfunction.The severity level is s3 per (b)(4) "bridging pfizer hal severity ranking to severity numbers applied in the thermacare heat wrap rmp", version 1.0, 28sep2018.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).Comment: based on the available information, the patient reported that "some wraps which could not use any more because they are leaked".The reported device leakage was identified prior to use of the device and the consumer did not use the device.There was "no adverse event" such as burn 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

Some wraps which could not use any more because they are leaked/it was the unsealed pouch that leaked [no adverse event].Case description: this case has been considered invalid since there is no indication that the consumer experienced an event under product thermacare, just product complaint.This is a spontaneous report from a contactable consumer (patient).A patient of unspecified age and gender started to receive thermacare heatwrap (thermacare neck shoulder wrist 8 hour) (lot/batch number: w61097, expiry: may2021) from an unspecified date for an unspecified indication.The patient's medical history and concomitant medications were not reported.On an unspecified date, the patient had a bad experience that there were some wraps which could not use anymore because they had leaked with the plastic package not the box.The patient advised there was a quality issue with the product.The patient reported this might be caused by packing machines and advised to check more about the machine in case of greater loss.The patient wanted to change their product by free returns.It was unknown whether the patient suffered an adverse event as a result of the event.As of 09may2019, the patient confirmed it was the unsealed pouch that leaked.On 30may2019, pfizer product complaint group provided investigational report: root cause of open pouches is equipment; specifically ultrasonic seal technology is not as forgiving in relation to the foil material as heat seal technology (external machine factors such as process variability and film material variability (wavy, wrinkles, thickness, surlyn conditions, etc.) affect the ability to keep the required film/product alignment and even pressure of the anvils across the sealing areas thus, compromising sealing integrity).In general, the leak defect rate has remained unchanged despite several reliability and engineering initiatives to improve the sealing performance.Capa: the (site name) consumer site will purchase and install three (3) new heat seal flow wrapper machines for b and m production lines.The existing bosch flow wrapper equipment used today employs ultrasonic sealing technology for both, the long and cross seals of the thermacare pouches.This technology has proven to be unreliable, difficult to maintain and not flexible enough to accommodate for material variances.The highest consumer complaint for the site is related to pouch sealing defects and the product never worked due to an open pouch.These complaints are directly related to failures during the sealing process.The new machines will utilize heat seal in the cross direction of the film/pouch to achieve a more consistent hermetic seal through the manufacturing runs with the added benefits of easier set up and operation.Complaint handling for open pouches: complaints received at the site in the global complaint database related to open pouch in the subclasses of (but not limited to) never worked, squeeze tube, did not last long enough and too cool will not be investigated in qts.These complaints will be evaluated in the global complaint database to ensure they are due to "open pouch" and the pouch sealing defect.No additional investigation will be required for these complaints based on the following: released batches meet criteria for pouch leaks at time of release.The severity of pouch leaks is s1 - no harm to customer.Complaints related to pouch seal have been thoroughly investigated and root cause is well understood.Leak rate for the current technology is about 2000 ppm.Capa is in-place to replace the ultrasonic sealers with heat seal technology.This document will be attached to the complaint record in the global database and closed with no further action taken.The root cause for never worked, too cool, did not last long enough and squeeze tube complaint sub classless is due to a pouch (primary packaging) that did not seal completely (open pouch).An open pouch will expose the wrap to air before the consumer gets it, causing it to be spent and not heating up.An open pouch is caused by equipment; specifically ultrasonic technology.The corrective action is to purchase and install three (3) new heat seal flow wrapper machines in both production lines.The severity of pouch leaks is s1 no harm to customer.Follow-up (09may2019 and 30may2019): new information reported from the same contactable consumer included: event details (it was the unsealed pouch that leaked) and case downgraded to invalid.New information reported from the product quality complaint group included: revised complaint.

Manufacturer Narrative

Root cause of open pouches is equipment; specifically ultrasonic seal technology is not as forgiving in relation to the foil material as heat seal technology (external machine factors such as process variability and film material variability (wavy, wrinkles, thickness, surlyn conditions, etc.) affect the ability to keep the required film/product alignment and even pressure of the anvils across the sealing areas thus, compromising sealing integrity).In general, the leak defect rate has remained unchanged despite several reliability and engineering initiatives to improve the sealing performance.Capa: the (site name) consumer site will purchase and install three (3) new heat seal flow wrapper machines for b and m production lines.The existing bosch flow wrapper equipment used today employs ultrasonic sealing technology for both, the long and cross seals of the thermacare pouches.This technology has proven to be unreliable, difficult to maintain and not flexible enough to accommodate for material variances.The highest consumer complaint for the site is related to pouch sealing defects and the product never worked due to an open pouch.These complaints are directly related to failures during the sealing process.The new machines will utilize heat seal in the cross direction of the film/pouch to achieve a more consistent hermetic seal through the manufacturing runs with the added benefits of easier set up and operation.Complaint handling for open pouches: complaints received at the site in the global complaint database related to open pouch in the subclasses of (but not limited to) never worked, squeeze tube, did not last long enough and too cool will not be investigated in qts.These complaints will be evaluated in the global complaint database to ensure they are due to "open pouch" and the pouch sealing defect.No additional investigation will be required for these complaints based on the following: released batches meet criteria for pouch leaks at time of release.

• 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: 8612787
• MDR Text Key: 205201343
• Report Number: 1066015-2019-00151
• 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: 04/28/2019

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: 05/01/2021
• Device Lot Number: W61097
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/15/2019
• Supplement Dates Manufacturer Received: 05/09/2019
• Supplement Dates FDA Received: 06/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1