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

Lot Number T65610

Device Problems Peeled/Delaminated (1454); Device Slipped (1584)

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

Event Date 09/01/2017

Event Type  Injury  

Event Description

She takes her pants up and down it's peeling off and again [device adhesion issue], she is using the wraps on her back/she doesn't press on it she doesn't feel the heat/she has to press on [device use issue].Case narrative: this is a spontaneous report from a contactable consumer reported for herself.A (b)(6) female patient started to receive thermacare heatwrap (thermacare neck, shoulder & wrist), lot number: t65610, expiry date: sep2020, upc number: (b)(4), from an unspecified date at 1 pk twice a day for pain.The patient medical history and concomitant medications were not reported.The patient said she had the thermacare heat wraps for the neck, wrist and shoulder but she was using the wraps on her back and neck in (b)(6) 2017.She said the wraps were working beautifully on her back.She thought that was what she bought.The thermacare neck, wrist and shoulder on her neck didn't stick.The tape kept opening.She also had a box she had not opened yet.She said she would need the thermacare heat wraps for the neck, wrist and shoulder.She then stated that what she had was thermacare for the neck and she had two boxes.She asked if she can wear the thermacare for the neck on her back.She clarified she had thermacare heat wraps neck pain therapy.She said there were 3 in each box.She had another box which also had three plus 1 additional wrap.There were four wraps in that box.She had two on now and used two wraps.The patient bought a 3+1 count package of thermacare advanced neck pain therapy from (name).She tried like 2 or 3 of them on her neck and the tape kept coming off.She also found that if she didn't press on it she didn't feel the heat in (b)(6) 2017.Her main concern was that she just ordered the product from (name) and received 2 more boxes that are unopened.She was going to europe and wanted to take them with her and needed to know that they're going to work.She did not know if there was one specifically for the back.She had one of the neck pain therapy wraps on her back and as she took her pants up and down it's peeling off and again, she had to press on it to feel the heat in (b)(6) 2017.The patient was hospitalized for the event "she takes her pants up and down it's peeling off and again".The patient was not admitted to hospital for the event "she is using the wraps on her back/she doesn't press on it she doesn't feel the heat /she has to press on".The patient did not receive any treatment for the events "she is using the wraps on her back/she doesn't press on it she doesn't feel the heat/she has to press on" and "she takes her pants up and down it's peeling off and again".The action taken in response to the events for thermacare heatwrap was permanently withdrawn on an unspecified date.The outcome of the events was not resolved.Follow-up (11sep2018): new information received from a contactable consumer included: new events (she doesn't press on it she doesn't feel the heat/she has to press on, she takes her pants up and down it's peeling off and again).Additional information has been requested and will be provided as it becomes available.Follow-up (19feb2019): new information received from a contactable consumer includes: age, dose, frequency, indication, action taken.The patient was not hospitalized for the event "she takes her pants up and down it's peeling off and again".The patient did not receive any treatment for the events "she is using the wraps on her back/she doesn't press on it she doesn't feel the heat/she has to press on" and "she takes her pants up and down it's peeling off and again".Follow-up (29mar2019): new information received from a contactable consumer includes: event details (including event onset date, event outcome).The patient was hospitalized for the event "she takes her pants up and down it's peeling off and again".This case is upgraded to a serious and reportable medical device report.Company clinical evaluation comment: based on the information provided, the event "she takes her pants up and down it's peeling off and again" with hospitalization as described in this case is considered as serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure.The event "device use issue" is non-serious.The events are assessed as associated with the use of the device.

Event Description

Event verbatim [preferred term] she takes her pants up and down it's peeling off and again [device adhesion issue] , she is using the wraps on her back/she doesn't press on it she doesn't feel the heat/she has to press on [device use issue] ,.Case narrative:this is a spontaneous report from a contactable consumer reported for herself.A 73-year-old female patient started to receive thermacare heatwrap (thermacare neck, shoulder & wrist), lot number: t65610, expiry date: sep2020, upc number: 305733015445, from an unspecified date at 1 pk twice a day for pain.The patient medical history and concomitant medications were not reported.The patient said she had the thermacare heat wraps for the neck, wrist and shoulder but she was using the wraps on her back and neck in sep2017.She said the wraps were working beautifully on her back.She thought that was what she bought.The thermacare neck, wrist and shoulder on her neck didn't stick.The tape kept opening.She also had a box she had not opened yet.She said she would need the thermacare heat wraps for the neck, wrist and shoulder.She then stated that what she had was thermacare for the neck and she had two boxes.She asked if she can wear the thermacare for the neck on her back.She clarified she had thermacare heat wraps neck pain therapy.She said there were 3 in each box.She had another box which also had three plus 1 additional wrap.There were four wraps in that box.She had two on now and used two wraps.The patient bought a 3+1 count package of thermacare advanced neck pain therapy from (name).She tried like 2 or 3 of them on her neck and the tape kept coming off.She also found that if she didn't press on it she didn't feel the heat in sep2017.Her main concern was that she just ordered the product from (name) and received 2 more boxes that are unopened.She was going to europe and wanted to take them with her and needed to know that they're going to work.She did not know if there was one specifically for the back.She had one of the neck pain therapy wraps on her back and as she took her pants up and down it's peeling off and again, she had to press on it to feel the heat in sep2017.The patient was hospitalized for the event "she takes her pants up and down it's peeling off and again".The patient was not admitted to hospital for the event "she is using the wraps on her back/she doesn't press on it she doesn't feel the heat /she has to press on".The patient did not receive any treatment for the events "she is using the wraps on her back/she doesn't press on it she doesn't feel the heat/she has to press on" and "she takes her pants up and down it's peeling off and again".The action taken in response to the events for thermacare heatwrap was permanently withdrawn on an unspecified date.The outcome of the events was not resolved.Additional information received from product quality complaint (pqc) group included investigation results.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 (11sep2018): new information received from a contactable consumer included: new events (she doesn't press on it she doesn't feel the heat/she has to press on, she takes her pants up and down it's peeling off and again).Follow-up (19feb2019): new information received from a contactable consumer includes: age, dose, frequency, indication, action taken.The patient was not hospitalized for the event "she takes her pants up and down it's peeling off and again".The patient did not receive any treatment for the events "she is using the wraps on her back/she doesn't press on it she doesn't feel the heat/she has to press on" and "she takes her pants up and down it's peeling off and again".Follow-up (29mar2019): new information received from a contactable consumer includes: event details (including event onset date, event outcome).The patient was hospitalized for the event "she takes her pants up and down it's peeling off and again".This case is upgraded to a serious and reportable medical device report.Follow-up (05jun2019): new information received from a product quality complaint group included: investigation results.Company clinical evaluation comment based on the information provided, the event "she takes her pants up and down it's peeling off and again" with hospitalization as described in this case is considered as serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure.The event "device use issue" is non-serious.The events are assessed as associated with the use of the device.Company conducted an investigation, and the most probable root cause for this event was classified, capa was implemented, and no further action is recommended., comment: based on the information provided, the event "she takes her pants up and down it's peeling off and again" with hospitalization as described in this case is considered as serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure.The event "device use issue" is non-serious.The events are assessed as associated with the use of the device.Company conducted an investigation, and the most probable root cause for this event was classified, capa was implemented, and no further action is recommended.

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: 8495592
• MDR Text Key: 141448605
• Report Number: 1066015-2019-00092
• Device Sequence Number: 0
• Product Code: IMD
• 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: 09/11/2018
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 04/09/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/01/2020
• Device Lot Number: T65610
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 73 YR