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

Lot Number J68754

Device Problems Break (1069); Leak/Splash (1354)

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

Event Type  malfunction  

Manufacturer Narrative

Investigation summary: complaint confirmed: yes.Process related: yes.Capa in place: yes.Capa reference: commitment pr# modify the logic of the brine system to shutdown the line when the dosing brine arm proximity switch is damage.Data of capa implementation: (b)(6) 2015.The most probable root cause of this incident is classified as equipment/equipment design.Evaluation of the return sample 03shows the wrap was not dosed with brine solution; therefore would not heat up.No quality issues were identified upon this review of batch records, release testing data or, inspection of retained samples.Retained samples met the product description and the product is in date.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.The root cause of the wraps not being dosed with brine solution was equipment: the logic was not programmed to detect if the proximity switch at the brine dosing arm is detecting the motion of the arm when the production line is running.This allowed the production line continue to run without incurring a fault even though the brine pumps were not being driven.Therefore, no brine was being injected into the cells producing products with lower weights that was detected at the check weigher and diverted from the packaging line.

Event Description

Event verbatim [preferred term] black spots on a heatwrap cells [device leakage] ,.Case narrative:this is a spontaneous report from a contactable pharmacist via product quality complaints.A patient of unspecified age and gender started to receive thermacare heatwrap (thermacare neck, shoulder & wrist), device lot number j68754, expiration date nov2017, date of manufacture 11dec2014, from an unspecified date for an unspecified indication.The patient's medical history and concomitant medications were not reported.The pharmacy reported black spots on a heatwrap cells on an unspecified date.The action taken with thermacare heatwrap was unknown.The outcome of the event was unknown.Product investigation results were received and were as follows: investigation summary: complaint confirmed: yes.Process related: yes.Capa in place: yes.Capa reference: commitment pr# modify the logic of the brine system to shutdown the line when the dosing brine arm proximity switch is damage.Data of capa implementation: (b)(6) 2015.The most probable root cause of this incident is classified as equipment/equipment design.Evaluation of the return sample 03shows the wrap was not dosed with brine solution; therefore would not heat up.No quality issues were identified upon this review of batch records, release testing data or, inspection of retained samples.Retained samples met the product description and the product is in date.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.The root cause of the wraps not being dosed with brine solution was equipment: the logic was not programmed to detect if the proximity switch at the brine dosing arm is detecting the motion of the arm when the production line is running.This allowed the production line continue to run without incurring a fault even though the brine pumps were not being driven.Therefore, no brine was being injected into the cells producing products with lower weights that was detected at the check weigher and diverted from the packaging line.Follow-up attempts not needed.No further information expected.Company clinical evaluation comment the event "black spots on a heatwrap cells " (device leakage) was assessed as non-serious.No other adverse event was associated with the use of the device.This is a single potential device malfunction has a theoretical risk to cause skin burn.The event was assessed as associated with the use of the device., comment: the event "black spots on a heatwrap cells " (device leakage) was assessed as non-serious.No other adverse event was associated with the use of the device.This is a single potential device malfunction has a theoretical risk to cause skin burn.The event was assessed as associated with the use of the device.

Event Description

Event verbatim [preferred term] black spots on a heatwrap cells [device leakage] ,.Case narrative:this is a spontaneous report from a contactable pharmacist via product quality complaints.A patient of unspecified age and gender started to receive thermacare heatwrap (thermacare neck, shoulder & wrist), device lot number j68754, expiration date nov2017, date of manufacture 11dec2014, from an unspecified date for an unspecified indication.The patient's medical history and concomitant medications were not reported.The pharmacy reported black spots on a heatwrap cells on an unspecified date.The action taken with thermacare heatwrap was unknown.The outcome of the event was unknown.Product investigation results were received and were as follows: investigation summary: complaint confirmed: yes.Process related: yes.Capa in place: yes.Capa reference: commitment pr# modify the logic of the brine system to shutdown the line when the dosing brine arm proximity switch is damage.Data of capa implementation: 24mar2015.The most probable root cause of this incident is classified as equipment/equipment design.Evaluation of the return sample 03shows the wrap was not dosed with brine solution; therefore would not heat up.No quality issues were identified upon this review of batch records, release testing data or, inspection of retained samples.Retained samples met the product description and the product is in date.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.The root cause of the wraps not being dosed with brine solution was equipment: the logic was not programmed to detect if the proximity switch at the brine dosing arm is detecting the motion of the arm when the production line is running.This allowed the production line continue to run without incurring a fault even though the brine pumps were not being driven.Therefore, no brine was being injected into the cells producing products with lower weights that was detected at the check weigher and diverted from the packaging line.Additional information has been requested and will be provided as it becomes available.Follow-up (24dec2019): this follow-up is being submitted to notify that an investigation of the device is ongoing.Company clinical evaluation comment the event "black spots on a heatwrap cells " (device leakage) was assessed as non-serious.No other adverse event was associated with the use of the device.This is a single potential device malfunction has a theoretical risk to cause skin burn.The event was assessed as associated with the use of the device., comment: the event "black spots on a heatwrap cells " (device leakage) was assessed as non-serious.No other adverse event was associated with the use of the device.This is a single potential device malfunction has a theoretical risk to cause skin burn.The event was assessed as associated with the use of the device.

Manufacturer Narrative

Investigation summary: complaint confirmed: yes.Process related: yes.Capa in place: yes.Capa reference: commitment pr# modify the logic of the brine system to shutdown the line when the dosing brine arm proximity switch is damage.Data of capa implementation: (b)(6) 2015.The most probable root cause of this incident is classified as equipment/equipment design.Evaluation of the return sample 03shows the wrap was not dosed with brine solution; therefore would not heat up.No quality issues were identified upon this review of batch records, release testing data or, inspection of retained samples.Retained samples met the product description and the product is in date.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.The root cause of the wraps not being dosed with brine solution was equipment: the logic was not programmed to detect if the proximity switch at the brine dosing arm is detecting the motion of the arm when the production line is running.This allowed the production line continue to run without incurring a fault even though the brine pumps were not being driven.Therefore, no brine was being injected into the cells producing products with lower weights that was detected at the check weigher and diverted from the packaging line.

Event Description

Event verbatim [preferred term] black spots on a heatwrap cells [device leakage] ,.Case narrative:this is a spontaneous report from a contactable pharmacist via product quality complaints regarding thermacare heatwrap (thermacare neck, shoulder & wrist), device lot number j68754, expiration date nov2017, date of manufacture 11dec2014.The pharmacy reported black spots on a heatwrap cells.The action taken with thermacare heatwrap was unknown.The outcome of the event was unknown.Product investigation results were received and were as follows: investigation summary: complaint confirmed: yes.Process related: yes.Capa in place: yes.Capa reference: commitment pr# modify the logic of the brine system to shutdown the line when the dosing brine arm proximity switch is damage.Data of capa implementation: 24mar2015.The most probable root cause of this incident is classified as equipment/equipment design.Evaluation of the return sample 03shows the wrap was not dosed with brine solution; therefore would not heat up.No quality issues were identified upon this review of batch records, release testing data or, inspection of retained samples.Retained samples met the product description and the product is in date.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.The root cause of the wraps not being dosed with brine solution was equipment: the logic was not programmed to detect if the proximity switch at the brine dosing arm is detecting the motion of the arm when the production line is running.This allowed the production line continue to run without incurring a fault even though the brine pumps were not being driven.Therefore, no brine was being injected into the cells producing products with lower weights that was detected at the check weigher and diverted from the packaging line.Follow-up (24dec2019): 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: the event "black spots on a heatwrap cells" (device leakage) was assessed as non-serious.No other adverse event was associated with the use of the device.This is a single potential device malfunction has a theoretical risk to cause skin burn.The event was 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

Investigation summary: complaint confirmed: yes.Process related: yes.Capa in place: yes.Capa reference: commitment pr# modify the logic of the brine system to shutdown the line when the dosing brine arm proximity switch is damage.Data of capa implementation: 24mar2015.The most probable root cause of this incident is classified as equipment/equipment design.Evaluation of the return sample 03shows the wrap was not dosed with brine solution; therefore would not heat up.No quality issues were identified upon this review of batch records, release testing data or, inspection of retained samples.Retained samples met the product description and the product is in date.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.The root cause of the wraps not being dosed with brine solution was equipment: the logic was not programmed to detect if the proximity switch at the brine dosing arm is detecting the motion of the arm when the production line is running.This allowed the production line continue to run without incurring a fault even though the brine pumps were not being driven.Therefore, no brine was being injected into the cells producing products with lower weights that was detected at the check weigher and diverted from the packaging line.

• 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: 9263339
• MDR Text Key: 220272856
• Report Number: 1066015-2019-00435
• 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: foreign,health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 02/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/31/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/01/2017
• Device Lot Number: J68754
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/10/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1